xml: <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/NCT06007664</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00224610</org_study_id>
      <secondary_id>1K01AG062754-01A1</secondary_id>
      <nct_id>NCT06007664</nct_id>
    </id_info>
    <brief_title>Tele-video to Improve Daily Activity</brief_title>
    <acronym>T-VIDA</acronym>
    <official_title>Leveraging Social Networks: a Novel Physical Activity Intervention for Senior Housing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</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 Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot study will test the feasibility of pairing a social network-based approach with a&#xD;
        6-week Occupational Therapist (OT)-led intervention administered remotely (via Zoom) to&#xD;
        increase physical function and activity among residents of a HUD subsidized&#xD;
        independent-living senior housing community. The intervention is called Tele-Video to Improve&#xD;
        Daily Activity (T-VIDA) and will be administered with two cohorts of residents in a single&#xD;
        community. The study has two main goals: 1) To determine if an OT-led program administered&#xD;
        remotely over the internet using Zoom is useful in helping residents increase their physical&#xD;
        activity; and 2) to determine if involving respected members of the community in the program&#xD;
        as Advisory Committee members has an impact on how much other residents participate in&#xD;
        program activities and engage in behaviors discussed. The OT intervention will be comprised&#xD;
        of a combination of adapted components from multiple evidence-based interventions including&#xD;
        individual meetings with an OT and OT-led group sessions. To evaluate the intervention pre-&#xD;
        and post-program interviews will be conducted with participants over the phone, and activity&#xD;
        monitoring will be conducted after both the pre- and post-program interviews for 7-days using&#xD;
        an activity monitoring device. The following hypotheses will be tested: 1) at least 75% (3 of&#xD;
        4) of identified residents will accept the invitation to serve on the Advisory Committee; 2)&#xD;
        Advisory Committee Members will attend at least 2 of 3 committee meetings; 3) Participants&#xD;
        will on average participate in at least 70% (7 of 10) of intervention activities; 4)&#xD;
        Residents knowing one or more committee members at baseline will participate in more&#xD;
        intervention activities compared to those who do not; and 5) The influence of knowing a&#xD;
        committee member on participation will be greater among residents reporting more pain at&#xD;
        baseline compared to those reporting less pain.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 23, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Process outcome - advisory committee members accept invitation</measure>
      <time_frame>1 week pre-intervention</time_frame>
      <description>Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 4.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Process outcome - advisory committee member participation</measure>
      <time_frame>Week 5 of intervention</time_frame>
      <description>Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Process outcome - individual activity participation</measure>
      <time_frame>Immediately after the intervention</time_frame>
      <description>Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Process outcome - group activity participation</measure>
      <time_frame>Immediately after the intervention</time_frame>
      <description>Number of group intervention activities attended by participants. Possible scores range from 0 to 4.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Process outcome - total activity participation</measure>
      <time_frame>Immediately after the intervention</time_frame>
      <description>Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Process outcome - number acitivites via zoom</measure>
      <time_frame>Immediately after the intervention</time_frame>
      <description>Number of activities attended via zoom as opposed to calling in by telephone. Scores frange from 0 to 10.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported physical activity</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>Modified Community Health Activities Model Program questionnaire. This includes 16 questions that measure the number of times and the frequency of each activity engaged in during a typical week in the past month on a scale ranging from 1=less than 1 hour to 6=9 or more hours. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in perceived barriers to physical activity</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This includes 17 questions that measure the degree to which specific things make it more difficult for participants to engage in 30 min of moderate intensity physical activity on 5 or more days a week. Questions are asked on a scale ranging from 1=much more difficult to 4=not al all more difficult. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain interference</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This includes 8 questions that measure how much pain interferes with daily acitivities. Questions are asked on a scale ranging from 1=not at all to 5=very much. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain intensity</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical function</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>The includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes ability to perform self-care, mobility, and household activities. Questions are asked about difficulty doing these activities on a scale ranging from 1=none to 4=alot. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-efficacy in activity</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This includes 10 questions that measure partcipants' confidence in doing a number of activities that will be discussed during the intervention. Questions are asked on a scale ranging from 1=completely confident to 6=not confident at all. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in number of other participants known</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This will include a measure of the number of other participants each particpant reports knowing. Possible scores range from 0 to 11. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in respect level of other participants</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sedentary behavior</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in number of steps</measure>
      <time_frame>1 week pre and 1 week post intervention</time_frame>
      <description>Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>occupational therapy intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tele-Video to Improve Daily Activity</intervention_name>
      <description>Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants.</description>
      <arm_group_label>occupational therapy intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  resident of the senior housing community of focus&#xD;
  &#xD;
            -  English-proficient&#xD;
  &#xD;
            -  ambulatory with or without assistive device (e.g., cane, walker)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  requiring use of a wheelchair for ambulation;&#xD;
  &#xD;
            -  requiring highly specialized equipment (e.g., spinal cord injury, leg amputation,&#xD;
               wound vacuum assisted closure, heavy leg boot);&#xD;
  &#xD;
            -  hospitalized within last 3 months;&#xD;
  &#xD;
            -  has probable dementia (TICSm score &lt;27);&#xD;
  &#xD;
            -  requiring ongoing complicated treatments (e.g., home oxygen use &gt;2 liters);&#xD;
  &#xD;
            -  has active mental health condition judged to pose significant barrier to&#xD;
               participation; and&#xD;
  &#xD;
            -  meets CDC recommendations for physical activity (150+ minutes of moderate-intensity&#xD;
               aerobic activity during typical week).&#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>Noah J Webster, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Noah J Webster, PhD</last_name>
      <phone>734-936-3075</phone>
      <email>njwebs@umich.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Noah J Webster</investigator_full_name>
      <investigator_title>Associate Research Scientist, Survey Research Center, Institute for Social Research</investigator_title>
    </responsible_party>
    <keyword>physical activity</keyword>
    <keyword>physical function</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007664
  org study id: HUM00224610
  secondary id: 1K01AG062754-01A1
  nct id: NCT06007664
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This pilot study will test the feasibility of pairing a social network-based approach with a
        6-week Occupational Therapist (OT)-led intervention administered remotely (via Zoom) to
        increase physical function and activity among residents of a HUD subsidized
        independent-living senior housing community. The intervention is called Tele-Video to Improve
        Daily Activity (T-VIDA) and will be administered with two cohorts of residents in a single
        community. The study has two main goals: 1) To determine if an OT-led program administered
        remotely over the internet using Zoom is useful in helping residents increase their physical
        activity; and 2) to determine if involving respected members of the community in the program
        as Advisory Committee members has an impact on how much other residents participate in
        program activities and engage in behaviors discussed. The OT intervention will be comprised
        of a combination of adapted components from multiple evidence-based interventions including
        individual meetings with an OT and OT-led group sessions. To evaluate the intervention pre-
        and post-program interviews will be conducted with participants over the phone, and activity
        monitoring will be conducted after both the pre- and post-program interviews for 7-days using
        an activity monitoring device. The following hypotheses will be tested: 1) at least 75% (3 of
        4) of identified residents will accept the invitation to serve on the Advisory Committee; 2)
        Advisory Committee Members will attend at least 2 of 3 committee meetings; 3) Participants
        will on average participate in at least 70% (7 of 10) of intervention activities; 4)
        Residents knowing one or more committee members at baseline will participate in more
        intervention activities compared to those who do not; and 5) The influence of knowing a
        committee member on participation will be greater among residents reporting more pain at
        baseline compared to those reporting less pain.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Process outcome - advisory committee members accept invitation
  time frame: 1 week pre-intervention
  description: Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 4.
  measure: Process outcome - advisory committee member participation
  time frame: Week 5 of intervention
  description: Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.
  measure: Process outcome - individual activity participation
  time frame: Immediately after the intervention
  description: Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.
  measure: Process outcome - group activity participation
  time frame: Immediately after the intervention
  description: Number of group intervention activities attended by participants. Possible scores range from 0 to 4.
  measure: Process outcome - total activity participation
  time frame: Immediately after the intervention
  description: Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.
  measure: Process outcome - number acitivites via zoom
  time frame: Immediately after the intervention
  description: Number of activities attended via zoom as opposed to calling in by telephone. Scores frange from 0 to 10.
  measure: Change in self-reported physical activity
  time frame: 1 week pre and 1 week post intervention
  description: Modified Community Health Activities Model Program questionnaire. This includes 16 questions that measure the number of times and the frequency of each activity engaged in during a typical week in the past month on a scale ranging from 1=less than 1 hour to 6=9 or more hours. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in perceived barriers to physical activity
  time frame: 1 week pre and 1 week post intervention
  description: This includes 17 questions that measure the degree to which specific things make it more difficult for participants to engage in 30 min of moderate intensity physical activity on 5 or more days a week. Questions are asked on a scale ranging from 1=much more difficult to 4=not al all more difficult. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in pain interference
  time frame: 1 week pre and 1 week post intervention
  description: This includes 8 questions that measure how much pain interferes with daily acitivities. Questions are asked on a scale ranging from 1=not at all to 5=very much. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in pain intensity
  time frame: 1 week pre and 1 week post intervention
  description: This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in physical function
  time frame: 1 week pre and 1 week post intervention
  description: The includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes ability to perform self-care, mobility, and household activities. Questions are asked about difficulty doing these activities on a scale ranging from 1=none to 4=alot. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in self-efficacy in activity
  time frame: 1 week pre and 1 week post intervention
  description: This includes 10 questions that measure partcipants' confidence in doing a number of activities that will be discussed during the intervention. Questions are asked on a scale ranging from 1=completely confident to 6=not confident at all. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in number of other participants known
  time frame: 1 week pre and 1 week post intervention
  description: This will include a measure of the number of other participants each particpant reports knowing. Possible scores range from 0 to 11. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in respect level of other participants
  time frame: 1 week pre and 1 week post intervention
  description: This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in sedentary behavior
  time frame: 1 week pre and 1 week post intervention
  description: Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
  measure: Change in number of steps
  time frame: 1 week pre and 1 week post intervention
  description: Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
  arm group label: occupational therapy intervention group
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Tele-Video to Improve Daily Activity
  description: Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants.
  arm group label: occupational therapy intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Noah J Webster, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Noah J Webster, PhD
  phone: 734-936-3075
  email: njwebs@umich.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Noah J Webster
  investigator title: Associate Research Scientist, Survey Research Center, Institute for Social Research
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Starting 6 months after publication