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Completed

NCT Number: NCT04942613

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Physical therapy interventions

Other

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

Education

Other

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

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.

Primary outcomes

  1. Adherence to the Multicomponent Telehealth Intervention

    Time frame: 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 outcomes

  1. Physical Activity

    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).

    Physical activity will be measured via accelerometry and will include average 7-day step count

  2. Feasibility of the Multicomponent Telehealth Intervention

    Time frame: 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.

  3. Acceptability of the Multicomponent Telehealth Intervention

    Time frame: 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."

  4. Participant Recruitment

    Time frame: 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.

  5. Satisfaction of the Multicomponent Telehealth Intervention

    Time frame: 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.

  6. Safety Event Count

    Time frame: 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

  7. Exercise Stages of Change Questionnaire

    Time frame: 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)

  8. Self-efficacy for Exercise (SEE) Scale

    Time frame: 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.

  9. 30 Second Sit to Stand

    Time frame: 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.

  10. Arm Curl Test

    Time frame: 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)

  11. 2-minute Step Test

    Time frame: 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.

  12. Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form

    Time frame: 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.

  13. 3-Item Loneliness Scale

    Time frame: 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.

  14. PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only

    Time frame: 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.

  15. Participant Retention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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