- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421999
Tele-video to Improve Daily Activity 2.0 (T-VIDA-2)
April 8, 2026 updated by: Noah J Webster, University of Michigan
Feasibility of a Remote Social Network-Based Occupational Therapy Intervention to Address Physical Function, Activity and Pain in Affordable Senior Housing
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community.
The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention.
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.
The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- resident of proposed intervention community (HUD subsidized independent-living senior housing community);
- English-proficient;
- ambulatory with or without assistive device (e.g., cane, walker)
Exclusion Criteria:
- requiring use of a wheelchair for ambulation;
- requiring highly specialized equipment (e.g., spinal cord injury, leg amputation, wound vacuum assisted closure, heavy leg boot);
- hospitalized within last 3 months;
- has probable dementia (TICSm score <27);
- requiring ongoing complicated treatments (e.g., home oxygen use >2 liters);
- has an active and untreated mental health condition; and
- meets CDC recommendations for physical activity (150+ minutes of moderate-intensity aerobic activity during typical week).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Occupational therapy intervention group
|
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community.
The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention.
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.
The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Process Outcome - Advisory Committee Member Participation
Time Frame: Week 5 of intervention
|
Number of committee meetings attended by Advisory Committee Members.
Possible scores range from 0 to 3.
|
Week 5 of intervention
|
|
Process Outcome - Individual Activity Participation
Time Frame: Immediately after the intervention, 6 weeks after the intervention started
|
Number of individual (one-on-one) intervention activities attended by participants.
Possible scores range from 0 to 6.
|
Immediately after the intervention, 6 weeks after the intervention started
|
|
Process Outcome - Group Activity Participation
Time Frame: Immediately after the intervention, 6 weeks after the intervention started
|
Number of group intervention activities attended by participants.
Possible scores range from 0 to 4.
|
Immediately after the intervention, 6 weeks after the intervention started
|
|
Process Outcome - Total Activity Participation
Time Frame: Immediately after the intervention, 6 weeks after the intervention started
|
Total number of intervention activities attended by participants (individual and group).
Possible scores range from 0 to 10.
|
Immediately after the intervention, 6 weeks after the intervention started
|
|
Process Outcome - Advisory Committee Members Accept Invitation
Time Frame: 1 week pre-intervention
|
Number of originally identified potential Advisory Committee Members who accept the invitation to serve on the committee.
Possible scores range from 0 to 2.
|
1 week pre-intervention
|
|
Process Outcome - Number Activities Via Zoom
Time Frame: Immediately after the intervention, 6 weeks after the intervention started
|
Number of activities attended via zoom as opposed to calling in by telephone.
Possible scores range from 0 to 10.
|
Immediately after the intervention, 6 weeks after the intervention started
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-reported Physical Activity
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
Modified Community Health Activities Model Program questionnaire.
This includes 16 questions/items that measure the number of times and the frequency of each activity engaged in during a typical week in the past month.
The response scale for each of the 16 items ranges from 1=less than 1 hour to 6=9 or more hours.
On this scale, higher values represent a better outcome.
A total self-reported physical activity score is calculated by averaging the score of all 16 items.
The range for the total score also ranges from 1 to 6. Change will be measured by creating a difference score between the pre and post intervention total scores.
Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Perceived Barriers to Physical Activity
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
This includes 17 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week.
The response scale for each of the 17 items ranges from 1=not at all more difficult to 4=much more difficult.
On this scale, lower values represent a better outcome.
A total perceived barriers to physical activity score is calculated by averaging the score of all 17 items.
The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores.
Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Pain Interference
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
This includes 8 questions/items that measure how much pain interferes with daily activities.
The response scale for each the 8 items ranges from 1=not at all to 5=very much.
On this scale, lower values represent a better outcome.
A total pain interference score is calculated by averaging the score of all 8 items.
The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores.
Negative change scores represent a better outcome, i.e., a decrease in pain interference.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Pain Intensity
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
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.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Physical Function Difficulty
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
This includes a modified version of the National Health and Aging Trends Study disability and functioning measure.
The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities.
The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot.
On this scale, lower values represent a better outcome.
A total physical function difficulty score is calculated by averaging the score of all 11 items.
The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores.
Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Self-efficacy in Activity
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention.
The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident.
On this scale, higher values represent a better outcome.
A total self-efficacy in activity score is calculated by averaging the score of all 10 items.
The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores.
Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Percentage of Other Participants Known
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
This will include a measure of the percentage of other participants each participant reports knowing.
Possible scores range from 0 to 100.
Change will be measured by creating a difference score between the pre and post intervention scores.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Respect Level of Other Participants
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
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.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Sedentary Behavior
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
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.
|
1 week pre and 1 week post the 6-week intervention
|
|
Change in Number of Steps
Time Frame: 1 week pre and 1 week post the 6-week intervention
|
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.
|
1 week pre and 1 week post the 6-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noah J Webster, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2026
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00238400
- P30AG022845 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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