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

NCT06288438 | Recruiting

• 2 other identifiers: E5012-R23-2306
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multimorbidity; Physical Deconditioning

Keywords

telerehabilitation; high intensity; biobehavioral; social support; physical activity

Outcome Measures

Primary Outcomes (1)

• 2 Minute Step Test

  This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance.

  Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

Secondary Outcomes (14)

• Arm Curl Test

  Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

• 30 Second Sit To Stand

  Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

• Physical Activity

  Will be collected at Baseline, 12 weeks, and 24 weeks.

• Exercise readiness to change

  Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

• Self-efficacy for Exercise Scale

  Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

Study Arms (2)

Multicomponent Telerehabilitation Intervention (Group 1)

EXPERIMENTAL

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).

Behavioral: Motivational Interviewing Techniques; Other: Physical Therapy Interventions

Education Control (Group 2)

OTHER

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.

Other: Education; Other: Health Status Updates; Other: Physical Therapy Consult

Interventions

Motivational Interviewing Techniques 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.

Multicomponent Telerehabilitation Intervention (Group 1)

Physical Therapy Interventions OTHER

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

Multicomponent Telerehabilitation Intervention (Group 1)

Education OTHER

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

Education Control (Group 2)

Health Status Updates 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.

Education Control (Group 2)

Physical Therapy Consult OTHER

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

Education Control (Group 2)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jennifer E. Stevens-Lapsley, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer E Stevens-Lapsley, PhD

CONTACT

(303) 949-9304; Jennifer.Stevens-Lapsley@va.gov

Maggie Givan, MA

CONTACT

(719) 251-7533; maggie.givan@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)