Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational Interviewing Techniques, Physical Therapy Interventions, Education, Health Status Updates.
- Who it may be relevant to
- Registry conditions: Multimorbidity, Physical Deconditioning. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
Overview
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.
Detailed 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.
Interventions
- 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 Education
Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc. - Other 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. - Other Physical Therapy Consult
Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.
Primary outcome measures
- 2 Minute Step Test [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
Secondary outcome measures (12)
- Arm Curl Test [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- 30 Second Sit To Stand [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Physical Activity [Time frame: Will be collected at Baseline, 12 weeks, and 24 weeks.]
- Exercise readiness to change [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Self-efficacy for Exercise Scale [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Self-efficacy of Managing Chronic Conditions [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- The Patient-Specific Functional Scale [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
- Physical Activity and Social Support Scale [Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Identifiers
NCT: NCT06288438 · E5012-R · 23-2306