Trials / Recruiting
RecruitingNCT06288438
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- VA Office of Research and Development · Federal
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.
Detailed description
The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Motivational Interviewing Techniques | Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. |
| OTHER | Physical Therapy Interventions | Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise. |
| OTHER | Education | Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc. |
| OTHER | Health Status Updates | Health Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances. |
| OTHER | Physical Therapy Consult | Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement. |
Timeline
- Start date
- 2024-04-18
- Primary completion
- 2026-11-02
- Completion
- 2028-03-31
- First posted
- 2024-03-01
- Last updated
- 2026-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06288438. Inclusion in this directory is not an endorsement.