Tele-video to Improve Daily Activity

Physical Inactivity Clinical Trial

— T-VIDA  

Official title:

Leveraging Social Networks: a Novel Physical Activity Intervention for Senior Housing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007664
• Other study ID #: HUM00224610
• Secondary ID: 1K01AG062754-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Noah J Webster, PhD
• Phone: 734-936-3075
• Email: njwebs[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• resident of the senior housing community of focus

• 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 active mental health condition judged to pose significant barrier to participation; and

• meets CDC recommendations for physical activity (150+ minutes of moderate-intensity aerobic activity during typical week).

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Tele-Video to Improve Daily Activity
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Process outcome - advisory committee members accept invitation	Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 4.	1 week pre-intervention
Primary	Process outcome - advisory committee member participation	Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.	Week 5 of intervention
Primary	Process outcome - individual activity participation	Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.	Immediately after the intervention
Primary	Process outcome - group activity participation	Number of group intervention activities attended by participants. Possible scores range from 0 to 4.	Immediately after the intervention
Primary	Process outcome - total activity participation	Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.	Immediately after the intervention
Primary	Process outcome - number acitivites via zoom	Number of activities attended via zoom as opposed to calling in by telephone. Scores frange from 0 to 10.	Immediately after the intervention
Secondary	Change in self-reported physical activity	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.	1 week pre and 1 week post intervention
Secondary	Change in perceived barriers to physical activity	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.	1 week pre and 1 week post intervention
Secondary	Change in pain interference	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.	1 week pre and 1 week post intervention
Secondary	Change in pain intensity	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 intervention
Secondary	Change in physical function	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.	1 week pre and 1 week post intervention
Secondary	Change in self-efficacy in activity	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.	1 week pre and 1 week post intervention
Secondary	Change in number of other participants known	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.	1 week pre and 1 week post intervention
Secondary	Change in respect level of other participants	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 intervention
Secondary	Change in sedentary behavior	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 intervention
Secondary	Change in number of steps	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 intervention