Clinical trial NCT06288438: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Official title: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multimorbidity
Physical Deconditioning
Keywords: telerehabilitation
high intensity
biobehavioral
social support
physical activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-03-01
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks.
Primary purpose: TREATMENT

Brief 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.

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.

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)

Primary outcomes:
measure: 2 Minute Step Test
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary outcomes:
measure: Arm Curl Test
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: 30 Second Sit To Stand
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Physical Activity
timeFrame: Will be collected at Baseline, 12 weeks, and 24 weeks.
measure: Exercise readiness to change
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Self-efficacy for Exercise Scale
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Self-efficacy of Managing Chronic Conditions
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: The Patient-Specific Functional Scale
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Physical Activity and Social Support Scale
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Geriatric Pain Measure
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
measure: Pain Coping Inventory
timeFrame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: