NCT06007664

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

August 17, 2023

Results QC Date

October 17, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

physical activityphysical function

Outcome Measures

Primary Outcomes (6)

  • 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 1.

    1 week pre-intervention

  • 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

  • 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, 6 weeks after the intervention started

  • Process Outcome - Group Activity Participation

    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

    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 - Number Acitivites Via Zoom

    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 Outcomes (10)

  • Change in Self-reported Physical Activity

    1 week pre and 1 week post the 6-week intervention

  • Change in Perceived Barriers to Physical Activity

    1 week pre and 1 week post the 6-week intervention

  • Change in Pain Interference

    1 week pre and 1 week post the 6-week intervention

  • Change in Pain Intensity

    1 week pre and 1 week post the 6-week intervention

  • Change in Physical Function Difficulty

    1 week pre and 1 week post the 6-week intervention

  • +5 more secondary outcomes

Study Arms (1)

occupational therapy intervention group

EXPERIMENTAL
Behavioral: Tele-Video to Improve Daily Activity

Interventions

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.

occupational therapy intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resident of the senior housing community of focus
  • English-proficient
  • ambulatory with or without assistive device (e.g., cane, walker)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Noah J. Webster
Organization
University of Michigan

Study Officials

  • Noah J Webster, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist, Survey Research Center, Institute for Social Research

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

August 23, 2023

Primary Completion

November 26, 2024

Study Completion

December 10, 2024

Last Updated

December 11, 2025

Results First Posted

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting 6 months after publication

Locations