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

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VA Office of Research and Development

Status

Enrolling

Conditions

Multimorbidity
Physical Deconditioning

Treatments

Other: Physical Therapy Consult
Other: Physical Therapy Interventions
Other: Education
Other: Health Status Updates
Behavioral: Motivational Interviewing Techniques

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06288438
E5012-R
23-2306 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

126 participants in 2 patient groups

Multicomponent Telerehabilitation Intervention (Group 1)
Experimental group
Description:
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).
Treatment:
Behavioral: Motivational Interviewing Techniques
Other: Physical Therapy Interventions
Education Control (Group 2)
Other group
Description:
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.
Treatment:
Other: Health Status Updates
Other: Education
Other: Physical Therapy Consult

Trial contacts and locations

1

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Central trial contact

Maggie Givan, MA; Jennifer E Stevens-Lapsley, PhD

Data sourced from clinicaltrials.gov

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