<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01690117</url>
  </required_header>
  <id_info>
    <org_study_id>IIA5-2512FSB552</org_study_id>
    <nct_id>NCT01690117</nct_id>
  </id_info>
  <brief_title>German Adaptation of REACH II</brief_title>
  <acronym>GE-REACH</acronym>
  <official_title>German Adaptation of Resources to Enhance Alzheimer's Caregiver Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leipzig</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to adapt, to implement and to evaluate an support program&#xD;
      for family caregivers of patients suffering from Alzheimers'Disease (AD). The intervention&#xD;
      was comprehensive developed and successful evaluated in the USA and is called Resources to&#xD;
      Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the effectiveness of&#xD;
      this German adaptation of REACH II the present implementation study is designed as randomized&#xD;
      and controlled trial. Primary outcome is reducing family caregiver burden.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caring for elderly people with dementia imposes a heavy strain on care providers like family&#xD;
      caregivers and puts them at risk of psychological and physical morbidity. A variety of&#xD;
      psychosocial interventions have been developed which aim at improving caregiver emotional and&#xD;
      physical health. These interventions differ in terms of treatment delivery (individual or&#xD;
      group format) and content (education, symptom appraisal, problem solving, skill building,&#xD;
      stress management or behavior modification). Systematic reviews and meta analyses have&#xD;
      concluded that individualized programs have a greater impact than group interventions, and&#xD;
      problem solving or behavior modification strategies are superior to education alone.&#xD;
      Structured multi-component interventions may also reduce the risk of patients home&#xD;
      admissions.&#xD;
&#xD;
      The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot;&#xD;
      (REACH II) is a multimodal, individualized and structured multi-component intervention&#xD;
      program for family caregivers and was successfully evaluated in a multisite, randomized and&#xD;
      controlled trial in the USA. The overall objectives of REACH II are to identify and reduce&#xD;
      modificable risk factors to enhance the well-being of the caregivers and to enhance the&#xD;
      quality of care. It takes place at caregivers home and focuses on 5 domains that are&#xD;
      important to caregivers: reducing depression, decreasing burden, improving self care,&#xD;
      enhancing social support, and managing problem behaviours.&#xD;
&#xD;
      Since there is a lack of effective treatment programs for family caregivers of demented&#xD;
      persons in the German Health system respectively care system the purpose of the present study&#xD;
      is to adapt and to implement REACH II to the care system conditions of a medium-sized East&#xD;
      German town (Leipzig). To test the effects of this adapted intervention program the present&#xD;
      study is design as unisite, randomized and controlled trail. Primary outcome is reducing&#xD;
      family caregiver burden.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6</measure>
    <time_frame>baseline and 6 month</time_frame>
    <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</measure>
    <time_frame>baseline and month 6</time_frame>
    <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</measure>
    <time_frame>baseline and month 9</time_frame>
    <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Dementia</condition>
  <condition>Family Caregiver</condition>
  <arm_group>
    <arm_group_label>GE-REACH-program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GE-REACH-program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GE-REACH-program</intervention_name>
    <description>The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
    <arm_group_label>GE-REACH-program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  age 21 years or older&#xD;
&#xD;
          -  living with or sharing cooking facilities with the care recipient&#xD;
&#xD;
          -  providing care for a relative with a medical diagnosed Alzheimer disease or related&#xD;
             disorder, vascular dementia or behavior variant frontotemporal dementia for at least 4&#xD;
             hours per day for at least the past 6 months&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Involvment in another caregiver intervention&#xD;
&#xD;
          -  actual psychiatric diagnosis of mental illness&#xD;
&#xD;
          -  illness that would prevent 6 months of study participation&#xD;
&#xD;
          -  forthcoming institutionalization of the person being cared.&#xD;
&#xD;
        Other requirements were logistic, including having a telephone, planning to remain in the&#xD;
        geographic area for at least 6 months, and competency in German.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hermann-Josef Gertz, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik und Poliklinik für Psychiatrie der Universität Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Psychiatrie und Psychotherapie</name>
      <address>
        <city>Leipzig</city>
        <state>Saxonia</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.</citation>
    <PMID>17116917</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>July 1, 2016</results_first_submitted>
  <results_first_submitted_qc>October 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 29, 2016</results_first_posted>
  <last_update_submitted>October 5, 2016</last_update_submitted>
  <last_update_submitted_qc>October 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>Hermann-Josef Gertz</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>family caregiver</keyword>
  <keyword>dementia</keyword>
  <keyword>intervention</keyword>
  <keyword>implementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DeREACH-program</title>
          <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Post-Measurement</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DeREACH-program</title>
          <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.3" spread="8.1"/>
                    <measurement group_id="B2" value="73.9" spread="8.2"/>
                    <measurement group_id="B3" value="73.1" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6</title>
        <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>DeREACH-program</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6</title>
          <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).</description>
          <population>The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="8.41"/>
                    <measurement group_id="O2" value="7.05" spread="8.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.83</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.82</ci_lower_limit>
            <ci_upper_limit>11.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9</title>
        <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>DeREACH-program</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9</title>
          <description>The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).</description>
          <population>The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="8.86"/>
                    <measurement group_id="O2" value="8.10" spread="8.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>9.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6</title>
        <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and 6 month</time_frame>
        <population>The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>DeREACH-program</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6</title>
          <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)</description>
          <population>The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.40" spread="3.48"/>
                    <measurement group_id="O2" value="1.59" spread="5.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>4.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9</title>
        <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>DeREACH-program</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9</title>
          <description>PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)</description>
          <population>The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="4.00"/>
                    <measurement group_id="O2" value="1.10" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.06</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.87</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>3.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6</title>
        <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6</title>
          <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)</description>
          <population>The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="3.09"/>
                    <measurement group_id="O2" value="0.05" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.30</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9</title>
        <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>usual care&#xD;
The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9</title>
          <description>PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)</description>
          <population>The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="2.65"/>
                    <measurement group_id="O2" value="0.68" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.24</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>2.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6</title>
        <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6</title>
          <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)</description>
          <population>The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="4.86"/>
                    <measurement group_id="O2" value="0.21" spread="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.50</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9</title>
        <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9</title>
          <description>ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)</description>
          <population>The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.55" spread="5.39"/>
                    <measurement group_id="O2" value="-0.74" spread="4.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.88</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.86</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.63</ci_lower_limit>
            <ci_upper_limit>2.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</title>
        <description>SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</title>
          <description>SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
          <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="8.70"/>
                    <measurement group_id="O2" value="-2.53" spread="8.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-4.93</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.74</ci_lower_limit>
            <ci_upper_limit>-1.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</title>
        <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</title>
          <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
          <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.87" spread="10.66"/>
                    <measurement group_id="O2" value="-4.62" spread="8.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.31</ci_lower_limit>
            <ci_upper_limit>-3.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</title>
        <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6</title>
          <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)</description>
          <population>The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="9.96"/>
                    <measurement group_id="O2" value="-1.31" spread="7.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.98</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.86</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</title>
        <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9</title>
          <description>SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)</description>
          <population>The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="9.59"/>
                    <measurement group_id="O2" value="0.19" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.91</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.96</ci_lower_limit>
            <ci_upper_limit>4.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</title>
        <description>RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</title>
          <description>RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)</description>
          <population>The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.62" spread="7.21"/>
                    <measurement group_id="O2" value="1.29" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>5.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</title>
        <description>The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</title>
          <description>The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)</description>
          <population>The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.41" spread="8.02"/>
                    <measurement group_id="O2" value="3.09" spread="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>8.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</title>
        <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)</description>
        <time_frame>baseline and month 6</time_frame>
        <population>The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6</title>
          <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)</description>
          <population>The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.46" spread="7.26"/>
                    <measurement group_id="O2" value="2.34" spread="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.40</ci_lower_limit>
            <ci_upper_limit>-0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</title>
        <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)</description>
        <time_frame>baseline and month 9</time_frame>
        <population>The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>DeREACH-program&#xD;
DeREACH-program: The intervention program &quot;Resources to Enhance Alzheimer's Caregivers Health -second step&quot; (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The informal caregivers of the control group only receive the standard supply of health care Services.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9</title>
          <description>RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)</description>
          <population>The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.17" spread="7.87"/>
                    <measurement group_id="O2" value="3.24" spread="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.78</ci_lower_limit>
            <ci_upper_limit>10.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Dr. Hermann-Josef Gertz</name_or_title>
      <organization>University of Leipzig, Medical Faculty, Clinic and Policlinic for Psychiatry and Psychotherapy</organization>
      <phone>0049 (0)341 97 24420</phone>
      <email>Hermann-Josef.Gertz@medizin.uni-leipzig.de</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01690117
org study id: IIA5-2512FSB552
nct id: NCT01690117
lead sponsor: 
has dmc: No
The purpose of the present study is to adapt, to implement and to evaluate an support program
      for family caregivers of patients suffering from Alzheimers'Disease (AD). The intervention
      was comprehensive developed and successful evaluated in the USA and is called Resources to
      Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the effectiveness of
      this German adaptation of REACH II the present implementation study is designed as randomized
      and controlled trial. Primary outcome is reducing family caregiver burden.
Caring for elderly people with dementia imposes a heavy strain on care providers like family
      caregivers and puts them at risk of psychological and physical morbidity. A variety of
      psychosocial interventions have been developed which aim at improving caregiver emotional and
      physical health. These interventions differ in terms of treatment delivery (individual or
      group format) and content (education, symptom appraisal, problem solving, skill building,
      stress management or behavior modification). Systematic reviews and meta analyses have
      concluded that individualized programs have a greater impact than group interventions, and
      problem solving or behavior modification strategies are superior to education alone.
      Structured multi-component interventions may also reduce the risk of patients home
      admissions.

      The intervention program "Resources to Enhance Alzheimer's Caregivers Health -second step"
      (REACH II) is a multimodal, individualized and structured multi-component intervention
      program for family caregivers and was successfully evaluated in a multisite, randomized and
      controlled trial in the USA. The overall objectives of REACH II are to identify and reduce
      modificable risk factors to enhance the well-being of the caregivers and to enhance the
      quality of care. It takes place at caregivers home and focuses on 5 domains that are
      important to caregivers: reducing depression, decreasing burden, improving self care,
      enhancing social support, and managing problem behaviours.

      Since there is a lack of effective treatment programs for family caregivers of demented
      persons in the German Health system respectively care system the purpose of the present study
      is to adapt and to implement REACH II to the care system conditions of a medium-sized East
      German town (Leipzig). To test the effects of this adapted intervention program the present
      study is design as unisite, randomized and controlled trail. Primary outcome is reducing
      family caregiver burden.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
time frame: baseline and month 6
description: The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).
measure: Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9
time frame: baseline and month 9
description: The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).
measure: Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
time frame: baseline and 6 month
description: PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9
time frame: baseline and month 9
description: PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)
measure: Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6
time frame: baseline and month 6
description: PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9
time frame: baseline and month 9
description: PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)
measure: Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6
time frame: baseline and month 6
description: ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)
measure: Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9
time frame: baseline and month 9
description: ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)
measure: Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
time frame: baseline and month 6
description: SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
time frame: baseline and month 9
description: SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)
measure: Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
time frame: baseline and month 6
description: SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
time frame: baseline and month 9
description: SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)
measure: Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
time frame: baseline and month 6
description: RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
time frame: baseline and month 9
description: The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)
measure: Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
time frame: baseline and month 6
description: RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)
measure: Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
time frame: baseline and month 9
description: RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)
arm group label: GE-REACH-program
arm group type: Experimental
description: GE-REACH-program
arm group label: control group
arm group type: No Intervention
description: usual care
intervention type: Behavioral
intervention name: GE-REACH-program
description: The intervention program "Resources to Enhance Alzheimer's Caregivers Health -second step" (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers
arm group label: GE-REACH-program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hermann-Josef Gertz, Prof. Dr.
role: Principal Investigator
affiliation: Klinik und Poliklinik für Psychiatrie der Universität Leipzig
facility: 
country: Germany
citation: Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
PMID: 17116917
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: Hermann-Josef Gertz
investigator title: Prof. Dr.
mesh term: Dementia
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 