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

NCT ID: NCT04942613

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2023-09-08

Brief Summary

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.

Detailed 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.

Conditions

Multimorbidity; Physical Deconditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multicomponent Telehealth Intervention (Group1)

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.

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

Qualitative Interview

Intervention Type: OTHER

Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.

Education (Group2)

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

Group Type: OTHER

Education

Intervention Type: OTHER

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

Qualitative Interview

Intervention Type: OTHER

Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.

Research Participants

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.

Group Type: OTHER

Qualitative Interview

Intervention Type: OTHER

Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.

Interventions

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

Intervention Type: OTHER

Qualitative Interview

Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer E. Stevens-Lapsley, PhD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-2773

Identifier Type: OTHER

Identifier Source: secondary_id

E3730-P

Identifier Type: -

Identifier Source: org_study_id