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

NCT04942613 | Completed Results

• 2 other identifiers: E3730-P21-2773
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimorbidity; Physical Deconditioning

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adherence to the Multicomponent Telehealth Intervention

  Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)

  Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Secondary Outcomes (15)

• Physical Activity

  Change from pre-program (baseline for Group 1, 12 weeks for Group 2) to post-program (12 weeks for Group 1, 24 weeks for Group 2).

• Feasibility of the Multicomponent Telehealth Intervention

  Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

• Acceptability of the Multicomponent Telehealth Intervention

  Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

• Participant Recruitment

  Baseline

• Satisfaction of the Multicomponent Telehealth Intervention

  Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Study Arms (3)

Multicomponent Telehealth Intervention (Group1)

EXPERIMENTAL

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.

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

Education (Group2)

OTHER

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

Other: Education; Other: Qualitative Interview

Research Participants

OTHER

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.

Other: Qualitative Interview

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 Telehealth Intervention (Group1)

Physical Therapy Interventions OTHER

strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise

Multicomponent Telehealth Intervention (Group1)

Education OTHER

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

Education (Group2)

Qualitative Interview 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); Multicomponent Telehealth Intervention (Group1); Research Participants

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 (Charlson Comorbidity Index 3)
• Impaired physical function (\< or = 10 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 without caregiver assistance (\< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
• Unstable medical condition precluding safe participation in progressive 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, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Jennifer Stevens-Lapsley
• Organization: University of Colorado Denver, Anschutz Medical Campus

jennifer.stevens-lapsley@cuanschutz.edu

303.724.9170

Study Officials

• Jennifer E. Stevens-Lapsley, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Participants will be randomized to 1 of 2 groups: Group1 will receive the intervention first for 12 weeks, and Group2 will receive the waitlist control for 12 weeks. At the end of 12 weeks, Group2 will crossover to the intervention.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 28, 2021
• Study Start: October 22, 2021
• Primary Completion: August 7, 2023
• Study Completion: September 8, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)