<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/NCT01699503</url>
  </required_header>
  <id_info>
    <org_study_id>R01AG040220-01A1</org_study_id>
    <secondary_id>1R01AG040220-01A1</secondary_id>
    <nct_id>NCT01699503</nct_id>
  </id_info>
  <brief_title>Indiana University Dementia Screening Trial</brief_title>
  <acronym>IU-CHOICE</acronym>
  <official_title>Indiana University Dementia Screening Trial: The IU CHOICE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to conduct a randomized clinical trial assessing the harms and&#xD;
      benefits of screening for dementia, compared to no screening for dementia, among 4,000 older&#xD;
      adults, cared for in typical, primary care practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this proposal is to address the question of whether the benefits outweigh&#xD;
      the harms of routine screening for dementia among older adults in primary care when the&#xD;
      screening program is coupled with primary care practices prepared to provide care for those&#xD;
      who screen positive.&#xD;
&#xD;
      The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing&#xD;
      the harms and benefits of screening for dementia, compared to no screening for dementia,&#xD;
      among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to&#xD;
      deliver best practices dementia care.&#xD;
&#xD;
      Primary Specific Aim 1:&#xD;
&#xD;
      Test the impact of dementia screening on health-related quality of life of the patient at 12&#xD;
      months.&#xD;
&#xD;
      Primary Specific Aim 2:&#xD;
&#xD;
      Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month&#xD;
      (i.e., primary potential harms).&#xD;
&#xD;
      Secondary Aims: Estimate the cost effectiveness of dementia screening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 22, 2017</completion_date>
  <primary_completion_date type="Actual">November 22, 2017</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>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Related Quality of Life (HRQOL)</measure>
    <time_frame>1 month, 6 months, 12 months</time_frame>
    <description>The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>1 month, 6 months, 12 months</time_frame>
    <description>The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder Scale (GAD-7)</measure>
    <time_frame>1 month, 6 months, 12 months</time_frame>
    <description>The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Health Care Utilization</measure>
    <time_frame>12 months</time_frame>
    <description>The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Advance Directive at 12 Months</measure>
    <time_frame>12 months</time_frame>
    <description>The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4005</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>No Screening</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Screening Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Collaborative Dementia Care Program</intervention_name>
    <description>Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
    <arm_group_label>Screening Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults age 65 and older;&#xD;
&#xD;
          -  at least one office visit to their primary care physician within the previous year;&#xD;
&#xD;
          -  no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or&#xD;
             the presence of prescription for anti-dementia medications (cholinesterase inhibitors&#xD;
             or memantine);&#xD;
&#xD;
          -  ability to consent to participate in the study; and&#xD;
&#xD;
          -  ability to communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adults who are a permanent resident of a nursing facility;&#xD;
&#xD;
          -  a serious mental illness such as bipolar disorder or schizophrenia as determined by&#xD;
             the presence of related ICD-9 codes indicative of such an illness; or&#xD;
&#xD;
          -  a pre-existing diagnosis of dementia or cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malaz Boustani, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regenstrief Institute, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IU Health-Primary Care Clinics</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wishard Health Services-Primary Care Clinics</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Arnett Primary Care Clinics</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20. doi: 10.1002/gps.1983.</citation>
    <PMID>18232061</PMID>
  </reference>
  <reference>
    <citation>Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.</citation>
    <PMID>12779304</PMID>
  </reference>
  <reference>
    <citation>Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.</citation>
    <PMID>21438862</PMID>
  </reference>
  <reference>
    <citation>Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.</citation>
    <PMID>22690979</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>October 31, 2018</results_first_submitted>
  <results_first_submitted_qc>January 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 23, 2019</results_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Regenstrief Institute, Inc.</investigator_affiliation>
    <investigator_full_name>Nicole R. Fowler, PhD</investigator_full_name>
    <investigator_title>Regenstrief Institute, IU Center for Aging Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT01699503/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Screening Group</title>
          <description>Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen (MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
        </group>
        <group group_id="P2">
          <title>No Screening</title>
          <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2008"/>
                <participants group_id="P2" count="1997"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Baseline</title>
              <participants_list>
                <participants group_id="P1" count="1723"/>
                <participants group_id="P2" count="1693"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="998"/>
                <participants group_id="P2" count="1022"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="903"/>
                <participants group_id="P2" count="893"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1008"/>
                <participants group_id="P2" count="992"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1000"/>
                <participants group_id="P2" count="1005"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded due to quality</title>
              <participants_list>
                <participants group_id="P1" count="783"/>
                <participants group_id="P2" count="791"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Screening Group</title>
          <description>Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen(MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
        </group>
        <group group_id="B2">
          <title>No Screening</title>
          <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</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="1723"/>
            <count group_id="B2" value="1693"/>
            <count group_id="B3" value="3416"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.2" spread="7.0"/>
                    <measurement group_id="B2" value="74.1" spread="6.8"/>
                    <measurement group_id="B3" value="74.1" spread="6.9"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1167"/>
                    <measurement group_id="B2" value="1089"/>
                    <measurement group_id="B3" value="2256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="556"/>
                    <measurement group_id="B2" value="604"/>
                    <measurement group_id="B3" value="1160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="526"/>
                    <measurement group_id="B2" value="530"/>
                    <measurement group_id="B3" value="1056"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1164"/>
                    <measurement group_id="B2" value="1137"/>
                    <measurement group_id="B3" value="2301"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Co-morbidity status, no (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Cancer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="379"/>
                    <measurement group_id="B2" value="392"/>
                    <measurement group_id="B3" value="771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic Lung Disease/Emphysema/COPD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="698"/>
                    <measurement group_id="B2" value="655"/>
                    <measurement group_id="B3" value="1353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congestive Heart Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="301"/>
                    <measurement group_id="B2" value="311"/>
                    <measurement group_id="B3" value="612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peripheral Vascular Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="257"/>
                    <measurement group_id="B3" value="510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coronary Artery Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="567"/>
                    <measurement group_id="B2" value="585"/>
                    <measurement group_id="B3" value="1152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="731"/>
                    <measurement group_id="B2" value="685"/>
                    <measurement group_id="B3" value="1416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1428"/>
                    <measurement group_id="B2" value="1383"/>
                    <measurement group_id="B3" value="2811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="390"/>
                    <measurement group_id="B2" value="393"/>
                    <measurement group_id="B3" value="783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson co-morbidity score, mean (SD)</title>
          <description>The Charlson Comorbidity Index is a method of predicting mortality by classifying or weighting co-morbid conditions. Each of the 12 comorbidity categories has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. Scores range from 0-24. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" spread="2.8"/>
                    <measurement group_id="B2" value="2.8" spread="3.0"/>
                    <measurement group_id="B3" value="2.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education level, no (%)</title>
          <population>22 participants refused to answer their education level</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1712"/>
                    <count group_id="B2" value="1682"/>
                    <count group_id="B3" value="3394"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="363"/>
                    <measurement group_id="B2" value="357"/>
                    <measurement group_id="B3" value="720"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="571"/>
                    <measurement group_id="B2" value="556"/>
                    <measurement group_id="B3" value="1127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college or college degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="778"/>
                    <measurement group_id="B2" value="769"/>
                    <measurement group_id="B3" value="1547"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-reported social support¥, mean (SD)</title>
          <description>Measured with the MOS-5 Social Support Inventory. The MOS Social Support Survey, a brief multidimensional self administered instrument, was selected to assess perceived support.The higher the score, the more perceived support. Scores range from 0-100.&#xD;
Compute raw score by adding scores on these 5 items Raw scores on this scale range from 5-25. Compute transformed score as follows: [(Raw score-5)/20] x 100</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.0" spread="4.5"/>
                    <measurement group_id="B2" value="20.8" spread="4.6"/>
                    <measurement group_id="B3" value="20.9" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study Site, no (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Urban, safety net health system</title>
                  <measurement_list>
                    <measurement group_id="B1" value="725"/>
                    <measurement group_id="B2" value="709"/>
                    <measurement group_id="B3" value="1434"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rural health system</title>
                  <measurement_list>
                    <measurement group_id="B1" value="653"/>
                    <measurement group_id="B2" value="624"/>
                    <measurement group_id="B3" value="1277"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Suburban and urban academic health system</title>
                  <measurement_list>
                    <measurement group_id="B1" value="345"/>
                    <measurement group_id="B2" value="360"/>
                    <measurement group_id="B3" value="705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health-related quality of life, mean (SD)</title>
          <description>Measured by the Health Utilities Index (HUI). A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death.The HUI classification system is comprised of 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain - each with 5 or 6 levels of ability/disability.Single-attribute scores of morbidity are defined on a scale such the worst level has a score of 0.00 and the best level has a score of 1.00. The higher the score, the better the health related quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.67" spread="0.27"/>
                    <measurement group_id="B2" value="0.67" spread="0.27"/>
                    <measurement group_id="B3" value="0.67" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depressive symptoms, mean (SD)</title>
          <description>Measured by the Patient Health Questionaire-9 (PHQ-9). The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day).Scores range from 0-27. A higher score means higher depressive symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.23" spread="4.07"/>
                    <measurement group_id="B2" value="3.06" spread="3.69"/>
                    <measurement group_id="B3" value="3.15" spread="3.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anxiety, mean (SD)</title>
          <description>Measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a valid and efficient tool for screening for Generalized Anxiety Disorder and assessing its severity in clinical practice and research.Scores range from 0-21, with 0-3 points for each of seven questions. A higher score is associated with more severe anxiety.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1723"/>
                    <count group_id="B2" value="1693"/>
                    <count group_id="B3" value="3416"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.79" spread="3.33"/>
                    <measurement group_id="B2" value="1.77" spread="3.19"/>
                    <measurement group_id="B3" value="1.78" spread="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Health Related Quality of Life (HRQOL)</title>
        <description>The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.</description>
        <time_frame>1 month, 6 months, 12 months</time_frame>
        <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Screening Group</title>
            <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
          </group>
          <group group_id="O2">
            <title>No Screening</title>
            <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life (HRQOL)</title>
          <description>The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.</description>
          <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</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="1723"/>
                <count group_id="O2" value="1693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="974"/>
                    <count group_id="O2" value="1000"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.24"/>
                    <measurement group_id="O2" value="0.69" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="885"/>
                    <count group_id="O2" value="875"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.26"/>
                    <measurement group_id="O2" value="0.70" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="993"/>
                    <count group_id="O2" value="976"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.27"/>
                    <measurement group_id="O2" value="0.68" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Health Questionnaire (PHQ-9)</title>
        <description>The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.</description>
        <time_frame>1 month, 6 months, 12 months</time_frame>
        <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Screening Group</title>
            <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
          </group>
          <group group_id="O2">
            <title>No Screening</title>
            <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire (PHQ-9)</title>
          <description>The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.</description>
          <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</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="1723"/>
                <count group_id="O2" value="1693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="996"/>
                    <count group_id="O2" value="1022"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="3.22"/>
                    <measurement group_id="O2" value="2.46" spread="3.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="903"/>
                    <count group_id="O2" value="893"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="3.43"/>
                    <measurement group_id="O2" value="2.45" spread="3.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1006"/>
                    <count group_id="O2" value="992"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" spread="3.69"/>
                    <measurement group_id="O2" value="2.82" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Generalized Anxiety Disorder Scale (GAD-7)</title>
        <description>The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.</description>
        <time_frame>1 month, 6 months, 12 months</time_frame>
        <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Screening Group</title>
            <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
          </group>
          <group group_id="O2">
            <title>No Screening</title>
            <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Generalized Anxiety Disorder Scale (GAD-7)</title>
          <description>The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.</description>
          <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</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="1723"/>
                <count group_id="O2" value="1693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="997"/>
                    <count group_id="O2" value="1022"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.16" spread="2.57"/>
                    <measurement group_id="O2" value="1.24" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="903"/>
                    <count group_id="O2" value="893"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="2.60"/>
                    <measurement group_id="O2" value="1.13" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1005"/>
                    <count group_id="O2" value="992"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="2.77"/>
                    <measurement group_id="O2" value="1.45" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Health Care Utilization</title>
        <description>The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Screening Group</title>
            <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
          </group>
          <group group_id="O2">
            <title>No Screening</title>
            <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Health Care Utilization</title>
          <description>The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1723"/>
                <count group_id="O2" value="1693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with at least 1 ED visit in 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510"/>
                    <measurement group_id="O2" value="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with at least 1 hospitalization in 12 mo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336"/>
                    <measurement group_id="O2" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Advance Directive at 12 Months</title>
        <description>The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.</description>
        <time_frame>12 months</time_frame>
        <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Screening Group</title>
            <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
          </group>
          <group group_id="O2">
            <title>No Screening</title>
            <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Advance Directive at 12 Months</title>
          <description>The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.</description>
          <population>The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="992"/>
                <count group_id="O2" value="1008"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="653"/>
                    <measurement group_id="O2" value="644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Screening Group</title>
          <description>Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.&#xD;
Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
        </group>
        <group group_id="E2">
          <title>No Screening</title>
          <description>Subjects who are randomized into the non-screening arm will receive the usual standard of care.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="1723"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="1693"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="1723"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="1693"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Incident Severe Depression (</sub_title>
                <description>Severe Depression is defined as PHQ-9 score of 15+</description>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="1723"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="1693"/>
              </event>
              <event>
                <sub_title>Incident Severe Anxiety</sub_title>
                <description>Severe Anxiety is defined as GAD-7 score of 15 - 21</description>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="1723"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="1693"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="1723"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1693"/>
              </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>Dr. Nicole Fowler</name_or_title>
      <organization>Indiana University</organization>
      <phone>317-274-9021</phone>
      <email>fowlern@iupui.edu</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/NCT01699503
org study id: R01AG040220-01A1
secondary id: 1R01AG040220-01A1
nct id: NCT01699503
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to conduct a randomized clinical trial assessing the harms and
      benefits of screening for dementia, compared to no screening for dementia, among 4,000 older
      adults, cared for in typical, primary care practices.
The objective of this proposal is to address the question of whether the benefits outweigh
      the harms of routine screening for dementia among older adults in primary care when the
      screening program is coupled with primary care practices prepared to provide care for those
      who screen positive.

      The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing
      the harms and benefits of screening for dementia, compared to no screening for dementia,
      among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to
      deliver best practices dementia care.

      Primary Specific Aim 1:

      Test the impact of dementia screening on health-related quality of life of the patient at 12
      months.

      Primary Specific Aim 2:

      Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month
      (i.e., primary potential harms).

      Secondary Aims: Estimate the cost effectiveness of dementia screening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Health Related Quality of Life (HRQOL)
time frame: 1 month, 6 months, 12 months
description: The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.
measure: Patient Health Questionnaire (PHQ-9)
time frame: 1 month, 6 months, 12 months
description: The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.
measure: Generalized Anxiety Disorder Scale (GAD-7)
time frame: 1 month, 6 months, 12 months
description: The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.
measure: Number of Participants With Health Care Utilization
time frame: 12 months
description: The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.
measure: Number of Participants With an Advance Directive at 12 Months
time frame: 12 months
description: The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.
arm group label: No Screening
arm group type: No Intervention
description: Subjects who are randomized into the non-screening arm will receive the usual standard of care.
arm group label: Screening Group
arm group type: Experimental
description: Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.
intervention type: Behavioral
intervention name: Collaborative Dementia Care Program
description: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
arm group label: Screening Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Malaz Boustani, MD, MPH
role: Principal Investigator
affiliation: Regenstrief Institute, Inc.
facility: 
facility: 
facility: 
country: United States
citation: Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20. doi: 10.1002/gps.1983.
PMID: 18232061
citation: Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.
PMID: 12779304
citation: Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.
PMID: 21438862
citation: Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.
PMID: 22690979
responsible party type: Principal Investigator
investigator affiliation: Regenstrief Institute, Inc.
investigator full name: Nicole R. Fowler, PhD
investigator title: Regenstrief Institute, IU Center for Aging Research Scientist
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 