Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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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

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Multimorbidity Physical Deconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will be blinded to group allocation.

Study Groups

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Multicomponent Telerehabilitation Intervention (Group 1)

Veterans randomized to the MCTR group will complete the 24-week study intervention consisting of the Active (weeks 1-6), Transition (weeks 7-12), and Sustainability (weeks 13-24) phases. Participants will receive a total of 16 individual sessions (6 integrated, 4 high-intensity rehabilitation, and 6 self-management intervention sessions).

Group Type EXPERIMENTAL

Motivational Interviewing Techniques

Intervention Type BEHAVIORAL

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.

Physical Therapy Interventions

Intervention Type OTHER

Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise.

Education Control (Group 2)

This group will not receive any exercise intervention but will complete 16 sessions with research staff through videoconferencing. These visits will consist of standardized Health Status Update and education sessions on general health topics.

Group Type OTHER

Education

Intervention Type OTHER

Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc.

Health Status Updates

Intervention Type OTHER

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.

Physical Therapy Consult

Intervention Type OTHER

Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.

Interventions

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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.

Intervention Type BEHAVIORAL

Physical Therapy Interventions

Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise.

Intervention Type OTHER

Education

Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 years of age and older
* Multiple chronic conditions (Functional Comorbidity Index \> or = 3)
* Impaired physical function (\< or = 8 repetitions on 30 second sit to stand test)

Exclusion Criteria

* Life expectancy \< 12 months
* Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke)
* Moderate to severe dementia (\<11 on telephone Montreal Cognitive Assessment(T-MoCA))
* Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No