<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/NCT04428112</url>
  </required_header>
  <id_info>
    <org_study_id>18-25814</org_study_id>
    <secondary_id>5R01AG057855-02</secondary_id>
    <secondary_id>3R01AG057855-02S1</secondary_id>
    <nct_id>NCT04428112</nct_id>
  </id_info>
  <brief_title>Rural Dementia Caregiver Project</brief_title>
  <official_title>Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
      These caregivers are a vulnerable group due to their physical isolation and well-documented&#xD;
      rural disparities in health care access and quality. Many rural dementia caregivers&#xD;
      experience serious health consequences due to caregiving responsibilities that can limit&#xD;
      their ability to maintain their caregiving role. Thus, there is a pressing need for&#xD;
      effective, scalable, and accessible programs to support rural dementia caregivers.&#xD;
&#xD;
      Online programs offer a convenient and readily translatable option for program delivery&#xD;
      because they can be accessed by caregivers in the home and at the convenience of the user.&#xD;
      Building Better Caregivers is an online 6-week, interactive, small-group self-management,&#xD;
      social support, and skills-building workshop developed for caregivers of individuals with&#xD;
      Alzheimer's disease or related dementia.&#xD;
&#xD;
      The investigators will conduct a hybrid effectiveness-implementation randomized controlled&#xD;
      trial that will enroll and randomize 640 rural dementia caregivers into two groups: the&#xD;
      intervention (workshop) group and the attention control group. Caregivers will be recruited&#xD;
      throughout the United States. Primary outcomes will be caregiver stress and depression&#xD;
      symptoms. The investigators hypothesize that stress scores and depression symptoms will be&#xD;
      significantly improved at 12 months in the intervention group versus control group. The&#xD;
      investigators will also identify key strengths (facilitators) and weaknesses (barriers) of&#xD;
      workshop implementation. The investigators will use the RE-AIM implementation framework and a&#xD;
      mixed methods approach to identify implementation characteristics pertinent to both&#xD;
      caregivers and rural community organizations.&#xD;
&#xD;
      If the Building Better Caregivers workshop is proven to be effective, this research has the&#xD;
      potential to open new research horizons, particularly on how to reach and effectively support&#xD;
      isolated dementia caregivers in rural areas with an intervention that is scalable, even in&#xD;
      low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers,&#xD;
      some of those most isolated, it would also be expected to be scalable in other low-resourced&#xD;
      settings (e.g., in urban or suburban environments).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual numeric stress scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Personal Health Questionnaire Depression (PHQ-8) scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Short Caregiver Self-Efficacy scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Zarit Burden Interview-12 (ZBI-12) scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver self-rated general health score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in person with dementia general health score as reported by caregiver from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UCLA loneliness scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lubben Social isolation scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver health care utilization from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in person with dementia health care utilization as reported by caregiver from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from caregiver report for past 12 months to caregiver report for past 6 months; scored as single items; with higher scores indicating worse outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in caregiver benefits scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>4-items measuring potential benefits of caregiving (e.g., providing care made caregiver feel useful, closer to care partner, good about self, and allowed caregiver to learn new skills) from the Health and Retirement Study. The scale score is calculated by summing each item to produce a total score between 0 and 4, with higher scores indicating better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in exercise behavior scale score from baseline to 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>6-items measuring exercise behaviors. Exercise behaviors include stretching/strengthening; walking; swimming/aquatic; bicycling (including stationary bikes); other aerobic exercise equipment (stairmaster, rowing, etc.); or other aerobic exercise. The scale score is calculated by summing each item to produce a total score between 0 and 1080, with higher scores indicating better outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">640</enrollment>
  <condition>Depression</condition>
  <condition>Stress, Psychological</condition>
  <condition>Self Efficacy</condition>
  <condition>Loneliness</condition>
  <condition>Social Isolation</condition>
  <condition>Health Care Utilization</condition>
  <condition>Dementia</condition>
  <condition>Dementia Alzheimers</condition>
  <condition>Dementia of Alzheimer Type</condition>
  <condition>Dementia, Vascular</condition>
  <condition>Dementia Frontal</condition>
  <condition>Dementia, Lewy Body</condition>
  <condition>Dementia, Mixed</condition>
  <condition>Dementia in Parkinsons Disease</condition>
  <condition>Dementia, HIV</condition>
  <condition>Dementia Frontotemporal</condition>
  <condition>Dementia, Multi-Infarct</condition>
  <arm_group>
    <arm_group_label>Building Better Caregivers Workshop Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Building Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be offered the online workshop after the 12 month trial is completed if they so desire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Building Better Caregivers Workshop</intervention_name>
    <description>Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require &quot;real time&quot; attendance at pre-determined times.</description>
    <arm_group_label>Building Better Caregivers Workshop Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.</description>
    <arm_group_label>Attention Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Caring for person with dementia&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Able to access the internet&#xD;
&#xD;
          -  Providing care for ≥ 10 hours per week&#xD;
&#xD;
          -  Reporting a minimum stress level of 4 or more on a 10-point scale&#xD;
&#xD;
          -  Living in rural area of United States (self-identify or zip code is a Rural Urban&#xD;
             Commuting Area Codes (RUCA) defined rural area)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an anticipated inability to complete the 12-month follow-up (e.g., planned&#xD;
             travel)&#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>Veronica Yank, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregiver</keyword>
  <keyword>Caregiving</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia, Vascular</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
    <mesh_term>Dementia, Multi-Infarct</mesh_term>
    <mesh_term>CADASIL</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The data will become available beginning within 3 months of article publication and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04428112
org study id: 18-25814
secondary id: 5R01AG057855-02
secondary id: 3R01AG057855-02S1
nct id: NCT04428112
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
These caregivers are a vulnerable group due to their physical isolation and well-documented
      rural disparities in health care access and quality. Many rural dementia caregivers
      experience serious health consequences due to caregiving responsibilities that can limit
      their ability to maintain their caregiving role. Thus, there is a pressing need for
      effective, scalable, and accessible programs to support rural dementia caregivers.

      Online programs offer a convenient and readily translatable option for program delivery
      because they can be accessed by caregivers in the home and at the convenience of the user.
      Building Better Caregivers is an online 6-week, interactive, small-group self-management,
      social support, and skills-building workshop developed for caregivers of individuals with
      Alzheimer's disease or related dementia.

      The investigators will conduct a hybrid effectiveness-implementation randomized controlled
      trial that will enroll and randomize 640 rural dementia caregivers into two groups: the
      intervention (workshop) group and the attention control group. Caregivers will be recruited
      throughout the United States. Primary outcomes will be caregiver stress and depression
      symptoms. The investigators hypothesize that stress scores and depression symptoms will be
      significantly improved at 12 months in the intervention group versus control group. The
      investigators will also identify key strengths (facilitators) and weaknesses (barriers) of
      workshop implementation. The investigators will use the RE-AIM implementation framework and a
      mixed methods approach to identify implementation characteristics pertinent to both
      caregivers and rural community organizations.

      If the Building Better Caregivers workshop is proven to be effective, this research has the
      potential to open new research horizons, particularly on how to reach and effectively support
      isolated dementia caregivers in rural areas with an intervention that is scalable, even in
      low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers,
      some of those most isolated, it would also be expected to be scalable in other low-resourced
      settings (e.g., in urban or suburban environments).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Change in visual numeric stress scale score from baseline to 12 months
time frame: Baseline and 12 months
description: A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
measure: Change in Personal Health Questionnaire Depression (PHQ-8) scale score from baseline to 12 months
time frame: Baseline and 12 months
description: Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
measure: Change in Short Caregiver Self-Efficacy scale score from baseline to 12 months
time frame: Baseline and 12 months
description: Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome.
measure: Change in Zarit Burden Interview-12 (ZBI-12) scale score from baseline to 12 months
time frame: Baseline and 12 months
description: Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
measure: Change in caregiver self-rated general health score from baseline to 12 months
time frame: Baseline and 12 months
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
measure: Change in person with dementia general health score as reported by caregiver from baseline to 12 months
time frame: Baseline and 12 months
description: Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
measure: Change in UCLA loneliness scale score from baseline to 12 months
time frame: Baseline and 12 months
description: UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome.
measure: Change in Lubben Social isolation scale score from baseline to 12 months
time frame: Baseline and 12 months
description: Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome.
measure: Change in caregiver health care utilization from baseline to 12 months
time frame: Baseline and 12 months
description: 3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome.
measure: Change in person with dementia health care utilization as reported by caregiver from baseline to 12 months
time frame: Baseline and 12 months
description: 3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from caregiver report for past 12 months to caregiver report for past 6 months; scored as single items; with higher scores indicating worse outcome.
measure: Change in caregiver benefits scale score from baseline to 12 months
time frame: Baseline and 12 months
description: 4-items measuring potential benefits of caregiving (e.g., providing care made caregiver feel useful, closer to care partner, good about self, and allowed caregiver to learn new skills) from the Health and Retirement Study. The scale score is calculated by summing each item to produce a total score between 0 and 4, with higher scores indicating better outcome.
measure: Change in exercise behavior scale score from baseline to 12 months
time frame: Baseline and 12 months
description: 6-items measuring exercise behaviors. Exercise behaviors include stretching/strengthening; walking; swimming/aquatic; bicycling (including stationary bikes); other aerobic exercise equipment (stairmaster, rowing, etc.); or other aerobic exercise. The scale score is calculated by summing each item to produce a total score between 0 and 1080, with higher scores indicating better outcome.
arm group label: Building Better Caregivers Workshop Group
arm group type: Experimental
description: Building Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization.
arm group label: Attention Control Group
arm group type: Active Comparator
description: Participants will be offered the online workshop after the 12 month trial is completed if they so desire.
intervention type: Behavioral
intervention name: Building Better Caregivers Workshop
description: Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require "real time" attendance at pre-determined times.
arm group label: Building Better Caregivers Workshop Group
intervention type: Behavioral
intervention name: Attention Control
description: Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.
arm group label: Attention Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Veronica Yank, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dementia
mesh term: Alzheimer Disease
mesh term: Dementia, Vascular
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia
mesh term: Lewy Body Disease
mesh term: Dementia, Multi-Infarct
mesh term: CADASIL
mesh term: Stress, Psychological
sharing ipd: Yes
ipd description: The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).
ipd info type: Study Protocol
ipd time frame: The data will become available beginning within 3 months of article publication and ending 5 years following article publication.
ipd access criteria: The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).