Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach

VA Office of Research and Development

Status: Completed

Conditions: Multimorbidity; Physical Deconditioning

Treatments: Other: Education; Other: Qualitative Interview; Other: Physical Therapy Interventions; Behavioral: Motivational Interviewing Techniques

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04942613

21-2773 (Other Identifier)

E3730-P

Details and patient eligibility

About

The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.

Full description

The aims of this study are to determine the feasibility and acceptability of the multicomponent telerehabilitation program and to preliminarily assess participant outcomes. The multicomponent program/intervention consists of 3 core components: 1) high-intensity rehabilitation interventions, 2) biobehavioral interventions, and 3) social support. The delivery of the program is supported by various technologies allowing for synchronous and asynchronous care and monitoring. Synchronous telerehabilitation will occur individually and in virtual groups. Feasibility and acceptability will be assessed by Veteran adherence to program components and validated surveys. Preliminary responsiveness will be assessed primarily by change in 7-day average step count and secondarily by other physical function tests and patient reported outcome measures. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation strategies for medically complex older Veterans who lack access to standard in-person rehabilitation services.

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 years of age and older
• Multiple chronic conditions (Charlson Comorbidity Index 3)
• Impaired physical function (< or = 10 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 without caregiver assistance (< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
• Unstable medical condition precluding safe participation in progressive rehabilitation (e.g. unstable angina)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Multicomponent Telehealth Intervention (Group1)

Experimental group

Description:

This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program.

Treatment:

Behavioral: Motivational Interviewing Techniques

Other: Physical Therapy Interventions

Other: Qualitative Interview

Education (Group2)

Other group

Description:

This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention

Treatment:

Other: Qualitative Interview

Other: Education

Research Participants

Other group

Description:

Participants will be asked to complete up to 2 semi-structured interviews following completion of the 12-week multicomponent intervention. The first interview will occur within 3 weeks of program completion (by week 15 for Group 1 and by week 27 for Group 2). The second interview will occur between 3 to 6 months after the first interview.

Treatment:

Other: Qualitative Interview