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

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)

Population: All participants; data from both groups will be pooled for analysis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.

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)

Population: All participants with complete data; data from both groups will be pooled for analysis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. Group 2 had 1 participant not complete this outcome measure.

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

Population: All Participants

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)

Population: All participants with complete data; data from both groups will be pooled for analysis.

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

Population: Number phone screened

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

Population: Total number of participants. The investigators considered retention to be study retention in addition to intervention retention, which included the outcome assessments at all time points. Thus, even though participants in Group 1 did not receive any intervention from weeks 12-24, they were still considered enrolled in the study until their 24 week outcome assessment was completed, they withdrew, or were lost to follow-up.

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).

Population: All participants with complete step count data will be analyzed. Since only pre-program and post-program data were collected, the data were pooled to increase statistical power.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.

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)

Population: Number of adverse events

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)

Population: All participants with complete data; data from both groups will be pooled for analysis.

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

Population: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.