Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions

Multimorbidity Clinical Trial

Official title:

Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288438
• Other study ID #: E5012-R
• Secondary ID: 23-2306
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Jennifer E Stevens-Lapsley, PhD
• Phone: (303) 949-9304
• Email: Jennifer.Stevens-Lapsley[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.

Description:

The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: March 31, 2028
• Est. primary completion date: November 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years of age and older
• Multiple chronic conditions (Functional Comorbidity Index > or = 3)
• Impaired physical function (< or = 8 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 (<11 on telephone Montreal Cognitive Assessment(T-MoCA))
• Medical conditions precluding safe participation in high-intensity 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, etc.
• Health Status Updates
Health Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances.
• Physical Therapy Consult
Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.

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	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 6 weeks, 12 weeks, and 24 weeks compared to the control group.
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 a 8 pound weight and females use a 5 pound weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
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 repetitions indicate better lower extremity strength.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Physical Activity	Physical activity will be measured via accelerometry and will include an averaged daily step count.	Will be collected at Baseline, 12 weeks, and 24 weeks.
Secondary	Exercise readiness to change	Four-item survey collected via interview format, and it is used to categorize participants into stages of change according to the Transtheoretical Model, possible stages include: (pre-contemplating, contemplation, preparation, action, and maintenance).	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Self-efficacy for Exercise Scale	A 9-item survey, each item is scored on a scale of 0 (not confident) to 10 (very confident) and higher scores indicate greater self-efficacy.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Self-efficacy of Managing Chronic Conditions	A 8-item survey rated on a 5-point Likert scale [I am not at all confident (1) to I am very confident (5)], and higher scored indicates better self-efficacy.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	The Patient-Specific Functional Scale	This is a questionnaire collected via interview format that quantifies activity or participation limitations that are important to the patient. Each participant identifies 3 activities that are important and that they are currently unable to do or having difficult performing due to their health; each item is then rated on a 0 (unable to preform activity) 0 to 10 (able to perform activity at the same level as before injury or problem) scale. The total score is an average of the 3 activities.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
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 in response to the prompt, "How much difficulty do you currently have..." Total scores range from 18 to 72 and higher scores indicate less difficulty with physical tasks.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey	This is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is one pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. Higher scores indicate more of the concept being measured.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a	An 8-item questionnaire rated on a 1 (never) to 5 (always) Likert scale. Higher scores indicate greater perceptions of loneliness and isolation, which is considered a worse outcome.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a	Includes 7 items rated on a 1 (not at all) to 5 (very much) Likert scale. Higher scores indicate greater satisfaction with discretionary social activities.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Physical Activity and Social Support Scale	A 20 -item survey rated on a scale of 1 (never true) to 7 (always true) that measures emotional, informational, instrumental, validation, and companionship support related to physical activity. Higher scores indicated greater levels of perceived social support.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Geriatric Pain Measure	Consists of 22 items scored as yes (1 point) or no (0 points) that assess whether or not a person does or would have pain during activities. There are also 2 items measured on a scale of 0 (no pain) to 10 (worst pain). Total scores range from 0-42 and adjusted scores range from 0-100 with higher scores indicating worse pain.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary	Pain Coping Inventory	This measures both active (transformation, distraction, reducing demands) and passive (retreating, worrying, resting) coping strategies. The inventory includes 34 items rated on a scale from 1 (hardly ever) to 4 (very often). Higher scores indicate more frequent use of each specific coping strategy.	Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.