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

Not Applicable

Completed

Conditions: Physical Deconditioning
Multimorbidity

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

Registration Number: NCT04942613

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Research Participants	Qualitative Interview	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.
Multicomponent Telehealth Intervention (Group1)	Motivational Interviewing Techniques	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.
Education (Group2)	Qualitative Interview	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
Multicomponent Telehealth Intervention (Group1)	Physical Therapy Interventions	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.
Multicomponent Telehealth Intervention (Group1)	Qualitative Interview	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.
Education (Group2)	Education	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

Primary Outcome Measures

Name	Time	Method
Adherence to the Multicomponent Telehealth Intervention	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)	Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)

Secondary Outcome Measures

Name	Time	Method
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).	Physical activity will be measured via accelerometry and will include average 7-day step count
Feasibility of the Multicomponent Telehealth Intervention	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)	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.
Acceptability of the Multicomponent Telehealth Intervention	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)	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."
Participant Recruitment	Baseline	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.
Satisfaction of the Multicomponent Telehealth Intervention	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)	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.
Safety Event Count	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)	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
Exercise Stages of Change Questionnaire	Change from Baseline to 12 weeks	Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)
Self-efficacy for Exercise (SEE) Scale	Change from Baseline to 12 weeks	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.
30 Second Sit to Stand	Change from Baseline to 12 weeks	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.
Arm Curl Test	Change from Baseline to 12 weeks	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)
2-minute Step Test	Change from Baseline to 12 weeks	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.
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form	Change from Baseline to 12 weeks	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.
3-Item Loneliness Scale	Change from Baseline to 12 weeks	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.
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only	Change from Baseline to 12 weeks	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.
Participant Retention	12 Weeks and 24 Weeks	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.