<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/NCT03033875</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092812</org_study_id>
    <secondary_id>1R01AG054079-01</secondary_id>
    <nct_id>NCT03033875</nct_id>
  </id_info>
  <brief_title>Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers</brief_title>
  <official_title>Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the psychoeducational program &quot;Tele-Savvy.&quot; Tele-Savvy&#xD;
      is an internet based, group education program developed from an in person program called&#xD;
      Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group&#xD;
      (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving&#xD;
      healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care&#xD;
      group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to&#xD;
      complete.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study addresses the reliance on family members to provide virtually all community-based&#xD;
      care for 5.3 million persons living with Alzheimer's disease and other dementias, a&#xD;
      population that will likely triple in the next 35 years. Unless researchers soon find a way&#xD;
      to prevent and cure dementing illnesses like Alzheimer's, the country will continue to face&#xD;
      an urgent need to find ways to sustain and bolster the capacity of these family caregivers to&#xD;
      manage the multiple daily care challenges they face and to preserve their well-being while&#xD;
      doing so. Without family caregivers, the burden of care could well overwhelm the formal&#xD;
      components of our care system. A number of psychoeducation programs for caregivers have been&#xD;
      effective in relieving distress, increasing self-efficacy, managing caregiving challenges,&#xD;
      and enabling caregivers to sustain care over longer periods of time. However, many&#xD;
      Alzheimer's caregivers cannot take part in these programs because virtually all such programs&#xD;
      require caregivers to arrange care for the care recipient while the caregivers attend the&#xD;
      programs. These are obstacles in rural or remote areas where transportation issues further&#xD;
      restrict caregivers' already limited access to caregiver programs, but they are no less a&#xD;
      problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our&#xD;
      ability to rely on caregivers as a continuing care resource for persons living with&#xD;
      Alzheimer's disease: there is a need for theory-driven psychoeducation programs that can be&#xD;
      made readily available to caregivers who may not be able to attend in-person programs.&#xD;
&#xD;
      This is a randomized trial to test a program designed to meet this critical need. This study&#xD;
      will test Tele-Savvy, an internet-based program based on the widely disseminated, in-person&#xD;
      Savvy Caregiver psychoeducation program. Delivered in scheduled videoconferences and&#xD;
      independently viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers'&#xD;
      skills and caregiving mastery, reduce adverse effects of caregiving, and improve the quality&#xD;
      of the lives of caregivers and care recipients.&#xD;
&#xD;
      Caregivers will be randomly assigned either to immediate Tele-Savvy participation groups or&#xD;
      to attention control or usual care groups that are invited to participate in Tele-Savvy six&#xD;
      months after baseline data collection. Each program takes 43 days to complete. In those 43&#xD;
      days, participants will be asked to take part in a video conference once per week (60-90&#xD;
      minutes) and view daily video lessons (7-15 minutes). The study includes 5 interviews over&#xD;
      the course of the 12 month study; the interviews at baseline and months 3 and 6 assess the&#xD;
      study outcome measures. These interviews will discuss participant's experience as a&#xD;
      caregiver. All interviews will be limited to 60 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">December 4, 2020</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>
    <intervention_model_description>Participants will be randomly assigned in a 2:2:1 ratio to the Tele-Savvy intervention, Healthy Living intervention, or usual care condition. Participants in the Healthy Living and usual care arms can take part i the Tele-Savvy intervention after a delay of 6 months.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zarit Burden Inventory (ZBI) Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) State Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS) Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Tele-Savvy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Tele-Savvy program immediately.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Healthy Living Education Program. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Informal caregivers of persons living with Alzheimer's disease will be randomized to continue to receive care through whatever arrangement has been in place. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele-Savvy</intervention_name>
    <description>The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers will receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.</description>
    <arm_group_label>Tele-Savvy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Living Education Program</intervention_name>
    <description>The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants will be asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant will also receive 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants will convene weekly for a video conference centered on the application of healthy living strategies. Facilitators will greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.</description>
    <arm_group_label>Attention Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informal caregivers (family/friends) of persons living with Alzheimer's disease or&#xD;
             another dementia&#xD;
&#xD;
          -  Participants must be providing at least 4 hours per day unpaid assistance, on average,&#xD;
             for a person in the early-middle stage of illness (Clinical Dementia Rating of greater&#xD;
             than or equal to 1 by home ADC) who is community-dwelling and for whom there is no&#xD;
             established plan for institutionalization in the next six months&#xD;
&#xD;
          -  Caregiver may or may not reside with their care recipient, but care recipients must&#xD;
             live in the community and not in an assisted living facility, nursing home, or another&#xD;
             institutional setting&#xD;
&#xD;
          -  Must have access to a computer or a mobile device with adequate internet connection,&#xD;
             microphone, and speakers (to be able to participate in teleconferences) and be able to&#xD;
             use email&#xD;
&#xD;
          -  Able to read, speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant must not be involved in another caregiver training study and must not&#xD;
             have participated in in-person Savvy Caregiver Program or Tele-Savvy previously&#xD;
&#xD;
          -  Uncorrectable vision or hearing deficits that might impede participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Hepburn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kovaleva M, Blevins L, Griffiths PC, Hepburn K. An Online Program for Caregivers of Persons Living With Dementia: Lessons Learned. J Appl Gerontol. 2019 Feb;38(2):159-182. doi: 10.1177/0733464817705958. Epub 2017 May 1.</citation>
    <PMID>28460557</PMID>
  </reference>
  <reference>
    <citation>Kovaleva MA, Bilsborough E, Griffiths PC, Nocera J, Higgins M, Epps F, Kilgore K, Lindauer A, Morhardt D, Shah RC, Hepburn K. Testing Tele-Savvy: Protocol for a randomized controlled trial. Res Nurs Health. 2018 Apr;41(2):107-120. doi: 10.1002/nur.21859. Epub 2018 Feb 5.</citation>
    <PMID>29399825</PMID>
  </reference>
  <results_reference>
    <citation>Hepburn K, Nocera J, Higgins M, Epps F, Brewster GS, Lindauer A, Morhardt D, Shah R, Bonds K, Nash R, Griffiths PC. Results of a Randomized Trial Testing the Efficacy of Tele-Savvy, an Online Synchronous/Asynchronous Psychoeducation Program for Family Caregivers of Persons Living with Dementia. Gerontologist. 2022 Apr 20;62(4):616-628. doi: 10.1093/geront/gnab029.</citation>
    <PMID>33640979</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>December 3, 2021</results_first_submitted>
  <results_first_submitted_qc>January 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2022</results_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Kenneth Hepburn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</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>December 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03033875/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03033875/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participant enrollment began May 18, 2017 and all study follow up was completed by December 4, 2020. Data collection to assess the outcome measures for this study occurred through the interview at month 6. Study activities continued through month 12 while participants in the Attention Control and Usual Care groups had the opportunity to have the Tele-Savvy intervention.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tele-Savvy Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.&#xD;
The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.</description>
        </group>
        <group group_id="P2">
          <title>Attention Control Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.&#xD;
The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants are asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant also receives 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants convene weekly for a video conference centered on the application of healthy living strategies. Facilitators greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.</description>
        </group>
        <group group_id="P3">
          <title>Usual Care Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 3 Assessment</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="83"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 6 Assessment</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="87"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tele-Savvy Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
        </group>
        <group group_id="B2">
          <title>Attention Control Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
        </group>
        <group group_id="B3">
          <title>Usual Care Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
        </group>
        <group group_id="B4">
          <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="96"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="54"/>
            <count group_id="B4" value="261"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="66.0" spread="10.9"/>
                    <measurement group_id="B2" value="63.8" spread="11.6"/>
                    <measurement group_id="B3" value="63.7" spread="10.7"/>
                    <measurement group_id="B4" value="64.6" spread="11.2"/>
                  </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="72"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                  </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>
              <title>Caregiver race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="192"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American/Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of person cared for</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.1" spread="8.6"/>
                    <measurement group_id="B2" value="74.4" spread="10.6"/>
                    <measurement group_id="B3" value="74.4" spread="10.3"/>
                    <measurement group_id="B4" value="74.6" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Relation to person cared for</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Spouse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-spouse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Zarit Burden Inventory (ZBI) Score</title>
        <description>The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Inventory (ZBI) Score</title>
          <description>The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.34" spread="13.77"/>
                    <measurement group_id="O2" value="35.78" spread="14.66"/>
                    <measurement group_id="O3" value="35.94" spread="15.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.26" spread="13.03"/>
                    <measurement group_id="O2" value="36.28" spread="13.49"/>
                    <measurement group_id="O3" value="37.82" spread="15.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="80"/>
                    <count group_id="O3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.54" spread="13.63"/>
                    <measurement group_id="O2" value="35.91" spread="12.96"/>
                    <measurement group_id="O3" value="37.48" spread="17.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>State-Trait Anxiety Inventory (STAI) State Score</title>
        <description>The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>State-Trait Anxiety Inventory (STAI) State Score</title>
          <description>The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.07" spread="11.96"/>
                    <measurement group_id="O2" value="34.61" spread="13.13"/>
                    <measurement group_id="O3" value="33.41" spread="11.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.90" spread="12.31"/>
                    <measurement group_id="O2" value="32.96" spread="11.50"/>
                    <measurement group_id="O3" value="35.00" spread="12.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.22" spread="9.97"/>
                    <measurement group_id="O2" value="34.07" spread="11.83"/>
                    <measurement group_id="O3" value="35.41" spread="12.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score</title>
        <description>The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score</title>
          <description>The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.14" spread="9.98"/>
                    <measurement group_id="O2" value="12.06" spread="10.09"/>
                    <measurement group_id="O3" value="11.08" spread="8.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.45" spread="9.23"/>
                    <measurement group_id="O2" value="10.52" spread="9.18"/>
                    <measurement group_id="O3" value="12.07" spread="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.51" spread="8.16"/>
                    <measurement group_id="O2" value="11.65" spread="10.08"/>
                    <measurement group_id="O3" value="12.93" spread="9.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score</title>
        <description>The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score</title>
          <description>The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.84" spread="9.78"/>
                    <measurement group_id="O2" value="12.34" spread="11.89"/>
                    <measurement group_id="O3" value="13.47" spread="12.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.36" spread="7.90"/>
                    <measurement group_id="O2" value="11.60" spread="9.01"/>
                    <measurement group_id="O3" value="14.50" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.30" spread="8.26"/>
                    <measurement group_id="O2" value="12.28" spread="9.82"/>
                    <measurement group_id="O3" value="15.00" spread="12.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score</title>
        <description>The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score</title>
          <description>The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.11" spread="2.12"/>
                    <measurement group_id="O2" value="12.44" spread="1.94"/>
                    <measurement group_id="O3" value="12.31" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.21" spread="1.46"/>
                    <measurement group_id="O2" value="12.49" spread="1.98"/>
                    <measurement group_id="O3" value="11.98" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.07" spread="1.71"/>
                    <measurement group_id="O2" value="12.62" spread="2.15"/>
                    <measurement group_id="O3" value="12.52" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score</title>
        <description>The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score</title>
          <description>The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.27" spread="2.12"/>
                    <measurement group_id="O2" value="11.63" spread="2.00"/>
                    <measurement group_id="O3" value="11.43" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.03" spread="2.06"/>
                    <measurement group_id="O2" value="11.35" spread="2.39"/>
                    <measurement group_id="O3" value="11.40" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.93" spread="2.21"/>
                    <measurement group_id="O2" value="11.78" spread="1.94"/>
                    <measurement group_id="O3" value="11.22" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Stress Scale (PSS) Score</title>
        <description>The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-Savvy Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
          <group group_id="O3">
            <title>Usual Care Group</title>
            <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress Scale (PSS) Score</title>
          <description>The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.</description>
          <population>This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.</population>
          <units>score 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="96"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.50" spread="8.93"/>
                    <measurement group_id="O2" value="22.66" spread="8.21"/>
                    <measurement group_id="O3" value="21.73" spread="7.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.77" spread="6.93"/>
                    <measurement group_id="O2" value="21.24" spread="7.63"/>
                    <measurement group_id="O3" value="23.86" spread="6.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="80"/>
                    <count group_id="O3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.72" spread="7.10"/>
                    <measurement group_id="O2" value="22.14" spread="8.08"/>
                    <measurement group_id="O3" value="23.50" spread="7.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Information on adverse events was collected beginning when individuals gave consent to participate in the study through the final study assessment (up to 12 months).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tele-Savvy Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.</description>
        </group>
        <group group_id="E2">
          <title>Attention Control Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
        </group>
        <group group_id="E3">
          <title>Usual Care Group</title>
          <description>Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </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="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Kenneth Hepburn</name_or_title>
      <organization>Emory University</organization>
      <phone>404-712-9286</phone>
      <email>khepbur@emory.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/NCT03033875
org study id: IRB00092812
secondary id: 1R01AG054079-01
nct id: NCT03033875
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the psychoeducational program "Tele-Savvy." Tele-Savvy
      is an internet based, group education program developed from an in person program called
      Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group
      (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving
      healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care
      group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to
      complete.
This study addresses the reliance on family members to provide virtually all community-based
      care for 5.3 million persons living with Alzheimer's disease and other dementias, a
      population that will likely triple in the next 35 years. Unless researchers soon find a way
      to prevent and cure dementing illnesses like Alzheimer's, the country will continue to face
      an urgent need to find ways to sustain and bolster the capacity of these family caregivers to
      manage the multiple daily care challenges they face and to preserve their well-being while
      doing so. Without family caregivers, the burden of care could well overwhelm the formal
      components of our care system. A number of psychoeducation programs for caregivers have been
      effective in relieving distress, increasing self-efficacy, managing caregiving challenges,
      and enabling caregivers to sustain care over longer periods of time. However, many
      Alzheimer's caregivers cannot take part in these programs because virtually all such programs
      require caregivers to arrange care for the care recipient while the caregivers attend the
      programs. These are obstacles in rural or remote areas where transportation issues further
      restrict caregivers' already limited access to caregiver programs, but they are no less a
      problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our
      ability to rely on caregivers as a continuing care resource for persons living with
      Alzheimer's disease: there is a need for theory-driven psychoeducation programs that can be
      made readily available to caregivers who may not be able to attend in-person programs.

      This is a randomized trial to test a program designed to meet this critical need. This study
      will test Tele-Savvy, an internet-based program based on the widely disseminated, in-person
      Savvy Caregiver psychoeducation program. Delivered in scheduled videoconferences and
      independently viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers'
      skills and caregiving mastery, reduce adverse effects of caregiving, and improve the quality
      of the lives of caregivers and care recipients.

      Caregivers will be randomly assigned either to immediate Tele-Savvy participation groups or
      to attention control or usual care groups that are invited to participate in Tele-Savvy six
      months after baseline data collection. Each program takes 43 days to complete. In those 43
      days, participants will be asked to take part in a video conference once per week (60-90
      minutes) and view daily video lessons (7-15 minutes). The study includes 5 interviews over
      the course of the 12 month study; the interviews at baseline and months 3 and 6 assess the
      study outcome measures. These interviews will discuss participant's experience as a
      caregiver. All interviews will be limited to 60 minutes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned in a 2:2:1 ratio to the Tele-Savvy intervention, Healthy Living intervention, or usual care condition. Participants in the Healthy Living and usual care arms can take part i the Tele-Savvy intervention after a delay of 6 months.
primary purpose: Other
masking: None (Open Label)
measure: Zarit Burden Inventory (ZBI) Score
time frame: Baseline, Month 3, Month 6
description: The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)
measure: State-Trait Anxiety Inventory (STAI) State Score
time frame: Baseline, Month 3, Month 6
description: The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
measure: Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score
time frame: Baseline, Month 3, Month 6
description: The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
time frame: Baseline, Month 3, Month 6
description: The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.
measure: Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score
time frame: Baseline, Month 3, Month 6
description: The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.
measure: Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score
time frame: Baseline, Month 3, Month 6
description: The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.
measure: Perceived Stress Scale (PSS) Score
time frame: Baseline, Month 3, Month 6
description: The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.
arm group label: Tele-Savvy Group
arm group type: Experimental
description: Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Tele-Savvy program immediately.
arm group label: Attention Control Group
arm group type: Other
description: Informal caregivers of persons living with Alzheimer's disease will be randomized to participate in the Healthy Living Education Program. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.
arm group label: Usual Care Group
arm group type: No Intervention
description: Informal caregivers of persons living with Alzheimer's disease will be randomized to continue to receive care through whatever arrangement has been in place. Persons in this group will be able to participate in the Tele-Savvy intervention after a delay of 6 months.
intervention type: Behavioral
intervention name: Tele-Savvy
description: The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers will receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.
arm group label: Tele-Savvy Group
intervention type: Behavioral
intervention name: Healthy Living Education Program
description: The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants will be asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant will also receive 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants will convene weekly for a video conference centered on the application of healthy living strategies. Facilitators will greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.
arm group label: Attention Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth Hepburn, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
citation: Kovaleva M, Blevins L, Griffiths PC, Hepburn K. An Online Program for Caregivers of Persons Living With Dementia: Lessons Learned. J Appl Gerontol. 2019 Feb;38(2):159-182. doi: 10.1177/0733464817705958. Epub 2017 May 1.
PMID: 28460557
citation: Kovaleva MA, Bilsborough E, Griffiths PC, Nocera J, Higgins M, Epps F, Kilgore K, Lindauer A, Morhardt D, Shah RC, Hepburn K. Testing Tele-Savvy: Protocol for a randomized controlled trial. Res Nurs Health. 2018 Apr;41(2):107-120. doi: 10.1002/nur.21859. Epub 2018 Feb 5.
PMID: 29399825
citation: Hepburn K, Nocera J, Higgins M, Epps F, Brewster GS, Lindauer A, Morhardt D, Shah R, Bonds K, Nash R, Griffiths PC. Results of a Randomized Trial Testing the Efficacy of Tele-Savvy, an Online Synchronous/Asynchronous Psychoeducation Program for Family Caregivers of Persons Living with Dementia. Gerontologist. 2022 Apr 20;62(4):616-628. doi: 10.1093/geront/gnab029.
PMID: 33640979
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Kenneth Hepburn
investigator title: Professor
mesh term: Alzheimer Disease
mesh term: Dementia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 