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

• ClinicalTrials.gov Identifier: NCT04942613
• Recruitment Status: Recruiting
• First Posted: June 28, 2021
• Last Update Posted: May 16, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multimorbidity; Physical Deconditioning	Behavioral: Motivational Interviewing Techniques; Other: Physical Therapy Interventions; Other: Education; Other: Qualitative Interview	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be randomized to 1 of 2 groups: Group1 will receive the intervention first for 12 weeks, and Group2 will receive the waitlist control for 12 weeks. At the end of 12 weeks, Group2 will crossover to the intervention.
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessor will be blinded to group allocation
• Primary Purpose: Treatment
• Official Title: Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
• Actual Study Start Date: October 22, 2021
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Adherence [ Time Frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) ]
   Adherence will be measured as a proportion of the number of sessions attended out of the number prescribed per protocol

Secondary Outcome Measures :

1. Physical Activity [ Time Frame: Change from Baseline to 12 weeks ]
   Physical activity will be measured via accelerometry and will include average 7-day step count
2. Qualitative Interview #2 [ Time Frame: to occur within 3 to 6 months of Qualitative Interview #1 ]
   Individual key informant interview conducted through the same virtual platform participants will have used throughout program participation. Interviews will last approximately 30-45 minutes, and the investigators will attempt to interview all participants who completed Qualitative Interview #1. Questions will explore factors that participants associate with maintenance of physical activity up to 6 months after program completion, with an emphasis on social support, strategies learned from biobehavioral interventions, and technology.
3. Feasibility of the Program [ 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. Higher scores indicate greater feasibility of the program
4. Acceptability of the Program [ 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. Higher scores indicated greater acceptability of the program.
5. Participant Recruitment [ Time Frame: through study completion, an average of 1.5 years ]
   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.
6. Satisfaction of the Program [ 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 assess via the VA's approved survey: V-signals. It consists of 11 items rated on a 5-point Likert scale (strongly disagree to strongly agree), and higher scores indicated better satisfaction
7. 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 adverse events and severe adverse events counted from baseline to program end. Events will be categorized by type
8. Exercise readiness to change [ 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)
9. Self-efficacy for Exercise [ 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), and higher scores indicated better self-efficacy.
10. 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.
11. 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)
12. 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.
13. 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. Higher scores indicated better mobility and less impairment/disability
14. 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.
15. PROMIS-29+2 Profile v2.1 [ Time Frame: Change from Baseline to 12 weeks ]
    This is a patient reported outcome measure to assess quality of life (summative score), social support (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. Higher scores for subscales listed indicate better quality of life, social support, and mental health.
16. Participant Retention [ Time Frame: through study completion, an average of 1.5 years ]
    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.
17. Qualitative Interview #1 [ Time Frame: to occur within 3 weeks of program completion ]
    Individual key informant interview conducted through the same virtual platform participants will have used throughout program participation. Interviews will last approximately 45-60 minutes, and participants will be purposively sampled according to group randomization. Questions will explore factors that participants associate with program engagement and participation as well as short-term changes in physical activity.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Contacts

Contact: Jennifer E Stevens-Lapsley, PhD; (303) 949-9304; Jennifer.Stevens-Lapsley@va.gov

Contact: Michelle R Rauzi, DPT; (208) 630-4002; michelle.rauzi@va.gov

Locations

United States, Colorado

Rocky Mountain Regional VA Medical Center, Aurora, CO; Recruiting

Aurora, Colorado, United States, 80045

Contact: Jennifer E Stevens-Lapsley, PhD 303-949-9304 Jennifer.Stevens-Lapsley@va.gov

Principal Investigator: Jennifer E. Stevens-Lapsley, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Jennifer E. Stevens-Lapsley, PhD; Rocky Mountain Regional VA Medical Center, Aurora, CO

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04942613
• Other Study ID Numbers: E3730-P; 21-2773 ( Other Identifier: COMIRB )
• First Posted: June 28, 2021
• Last Update Posted: May 16, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

telerehabilitation; high intensity; biobehavioral; social support; physical activity