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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
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)
Time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Physical Activity
Physical activity will be measured via accelerometry and will include average 7-day step count
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: Baseline
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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.
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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Weeks and 24 Weeks