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

Multimorbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942613
• Other study ID #: E3730-P
• Secondary ID: 21-2773
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: September 8, 2023

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 8, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multimorbidity
• Physical Deconditioning

Intervention

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

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Adherence will be measured as a proportion of the number of sessions attended out of the number prescribed per protocol	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary	Physical Activity	Physical activity will be measured via accelerometry and will include average 7-day step count	Change from Baseline to 12 weeks
Secondary	Feasibility of the Program	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	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary	Qualitative Interview #2	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.	to occur within 3 to 6 months of Qualitative Interview #1
Secondary	Acceptability of the Program	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.	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary	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.	through study completion, an average of 1.5 years
Secondary	Satisfaction of the Program	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	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary	Safety Event Count	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	Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary	Exercise readiness to change	Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)	Change from Baseline to 12 weeks
Secondary	Self-efficacy for Exercise	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.	Change from Baseline to 12 weeks
Secondary	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.	Change from Baseline to 12 weeks
Secondary	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)	Change from Baseline to 12 weeks
Secondary	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.	Change from Baseline to 12 weeks
Secondary	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. Higher scores indicated better mobility and less impairment/disability	Change from Baseline to 12 weeks
Secondary	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.	Change from Baseline to 12 weeks
Secondary	PROMIS-29+2 Profile v2.1	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.	Change from Baseline to 12 weeks
Secondary	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.	through study completion, an average of 1.5 years
Secondary	Qualitative Interview #1	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.	to occur within 3 weeks of program completion