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

Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability

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.

Study Overview

• Status: Completed
• Conditions: Physical Deconditioning; Multimorbidity
• Intervention / Treatment: Behavioral: Motivational Interviewing Techniques; Other: Physical Therapy Interventions; Other: Qualitative Interview; Other: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other: Physical Therapy Interventions; strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise; 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.
Other: 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	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.; Other: Education; Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-Item Loneliness Scale	This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.	Change from Baseline to 12 weeks
Physical Activity	Physical activity will be measured via accelerometry and will include average 7-day step count	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	Feasibility will be measured through a validated survey: Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater feasibility of the program.	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Acceptability of the Multicomponent Telehealth Intervention	Acceptability will be measured through a validated survey: Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater acceptability of the program."	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Participant Recruitment	Recruitment will be tracked as part of feasibility and to inform a future trial. Recruitment will be reported as a proportion of those enrolled out of the total number screened via phone screen.	Baseline
Satisfaction of the Multicomponent Telehealth Intervention	Participation satisfaction with care provided via telerehabilitation will be assessed via the VA's approved survey: V-signals. It consists of 11 items rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree). The average of the 11 items are reported. Higher scores indicate better satisfaction.	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Safety Event Count	The Safety Event Count is the cumulative number of study related (possibly, probably, or definitely) adverse events and severe adverse events counted from baseline to program end. Events will be categorized by type	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Exercise Stages of Change Questionnaire	Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)	Change from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale	Nine item questionnaire used to measure an individual's self-efficacy for exercising under different conditions. Each item is rated on a scale of 0 (not confident) to 10 (confident). The average of the 9 items is calculated; higher scores indicate better self-efficacy. The change from baseline to 12 weeks is calculated as 12 weeks minus baseline; thus, positive change scores indicate improvement in self-efficacy.	Change from Baseline to 12 weeks
30 Second Sit to Stand	The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function.	Change from Baseline to 12 weeks
Arm Curl Test	This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (biceps curls) as possible in 30 seconds. Males use an 8lb weight and females use a 5lb weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)	Change from Baseline to 12 weeks
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 12 weeks
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form	This questionnaire consists of 18 items rated on a 4-point Likert scale from 1 (unable) to 4 (none) to address the prompt: How much difficulty do you currently have. The total score is reported by summing each item; scores can range from 18 to 72. Higher scores indicate better mobility and less impairment/disability.	Change from Baseline to 12 weeks
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only	This is a patient reported outcome measure to assess physical health (subscale) and mental health (subscale). It is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is 1 pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. PROMIS scores were transformed to a T-score where 50 represents the population mean, and the standard deviation is 10. The method reported by Hays et al. in 2018 was used to calculate the physical health and mental health subscales. Higher scores for subscales listed indicate better physical and mental health.	Change from Baseline to 12 weeks
Participant Retention	Participant retention will be tracked as part of feasibility and to inform a future trial. Retention will be reported as a proportion of the total number of participants who complete all outcome measure timepoints out of the total who complete baseline measures.	12 Weeks and 24 Weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jennifer E. Stevens-Lapsley, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; social support; telerehabilitation; high intensity; biobehavioral
• Other Study ID Numbers: E3730-P; 21-2773 (Other Identifier: COMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No