Telerehabilitation for Multi-morbidity

Overseen By Maggie Givan, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological disorders, Dementia, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new telerehabilitation program, Multicomponent Telerehabilitation, can improve strength and physical function in older Veterans with complex health conditions more effectively than traditional methods. Participants in the experimental group will undergo a 24-week program that includes high-intensity rehab, self-management, and social support via telehealth. The control group will receive health education sessions without exercise intervention. Veterans aged 60 or older with multiple chronic conditions and difficulties in physical activities, such as repeatedly standing up from a chair, might be suitable candidates for this trial. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative rehabilitation methods that could enhance their quality of life.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telerehabilitation program is safe for older Veterans?

A previous study found the telerehabilitation program to be as safe as traditional in-person physical therapy. Most reported safety issues related to participants' existing health conditions, not the program itself, suggesting it is generally well-tolerated. Participants completed their sessions without major problems, demonstrating the program's practicality and safety for older adults with multiple health issues. Thus, while joining involves trying something new, it appears as safe as regular physical therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multicomponent telerehabilitation approach for managing multi-morbidity because it offers a unique blend of integrated, high-intensity rehabilitation and self-management sessions, all delivered via telehealth. Unlike traditional in-person rehabilitation programs, this method provides flexibility and accessibility for patients, allowing them to engage in their treatment from home. Additionally, the structured phases—Active, Transition, and Sustainability—are designed to support long-term health improvements and empower patients to manage their conditions independently. This approach could significantly enhance the convenience and effectiveness of rehabilitation for individuals with multiple chronic conditions.

What evidence suggests that the Multicomponent Telerehabilitation program could be effective for improving physical function in older Veterans?

Studies have shown that guided telerehabilitation can help older adults improve their physical abilities. In this trial, participants in the Multicomponent TeleRehabilitation (MCTR) group will engage in a program combining intense rehabilitation exercises, coaching, and social support to enhance physical function. Previous participants in similar programs demonstrated increased strength and improved performance in daily activities. Research also shows that older veterans find this approach practical and acceptable. This suggests that the MCTR program could effectively help older veterans with complex medical needs maintain their physical abilities and quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer E. Stevens-Lapsley, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for older Veterans with multiple chronic health conditions and physical weakness, who often feel socially isolated. They should be able to engage in high-intensity rehabilitation and self-management programs via telehealth. Specific eligibility details are not provided.

Inclusion Criteria

Multiple chronic conditions (Functional Comorbidity Index > or = 3)

I am 60 years old or older.

I can do 8 or fewer chair stands in 30 seconds.

Exclusion Criteria

Life expectancy < 12 months

Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA))

I do not have a worsening neurological condition like ALS or a recent stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Phase

Participants engage in high-intensity rehabilitation and self-management interventions

6 weeks

6 integrated sessions, 4 high-intensity rehabilitation sessions, 6 self-management intervention sessions

Transition Phase

Participants continue with rehabilitation and self-management interventions with a focus on transitioning to self-directed activities

6 weeks

Sustainability Phase

Participants focus on sustaining physical function and self-management practices

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multicomponent Telerehabilitation

Trial Overview The study tests a Multicomponent Telerehabilitation (MCTR) program that combines motivational talks, physical therapy, health updates, consultations, and education against traditional rehab methods to see if it better improves strength and function.

How Is the Trial Designed?

Group I: Multicomponent Telerehabilitation Intervention (Group 1) Experimental Treatment 2 Interventions

Veterans randomized to the MCTR group will complete the 24-week study intervention consisting of the Active (weeks 1-6), Transition (weeks 7-12), and Sustainability (weeks 13-24) phases. Participants will receive a total of 16 individual sessions (6 integrated, 4 high-intensity rehabilitation, and 6 self-management intervention sessions).

Group II: Education Control (Group 2) Experimental Treatment 3 Interventions

This group will not receive any exercise intervention but will complete 16 sessions with research staff through videoconferencing. These visits will consist of standardized Health Status Update and education sessions on general health topics.

Multicomponent Telerehabilitation is already approved in United States for the following indications:

Approved in United States as Telerehabilitation for:

• Rehabilitation for medically complex older Veterans with complex health conditions

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A systematic review of 15 studies involving 1339 poststroke patients found that telerehabilitation did not show significant differences in key rehabilitation outcomes compared to traditional care, indicating its efficacy may be comparable to usual rehabilitation methods.

Telerehabilitation was associated with lower costs, saving approximately $867 compared to usual care, suggesting it could be a cost-effective alternative, especially for patients in remote or underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation for Stroke Survivors: Systematic Review and Meta-Analysis. Tchero, H., Tabue Teguo, M., Lannuzel, A., et al.[2019]

In a study involving ten chronic post-stroke subjects, the telerehabilitation system Muvity showed potential benefits, with four out of six participants improving their ability to perform daily activities and five reporting less pain compared to conventional therapy.

While the results were promising, indicating that Muvity could be a motivating and effective complement to traditional rehabilitation, the differences were not statistically significant, highlighting the need for further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of Muvity: A telerehabilitation system for chronic post-stroke subjects. Garcia, A., Mayans, B., Margelí, C., et al.[2022]

Telerehabilitation can effectively maintain therapeutic relationships and provide support for families during pediatric rehabilitation, as shown by feedback from 67 sessions involving children averaging 11.3 years old.

Therapists reported a stronger ability to maintain therapeutic alliances compared to achieving other goals, indicating that while telerehabilitation is effective, there may be challenges in delivering certain aspects of care, especially for younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition to Multidisciplinary Pediatric Telerehabilitation during the COVID-19 Pandemic: Strategy Development and Implementation. Krasovsky, T., Silberg, T., Barak, S., et al.[2021]

Cardiac telerehabilitation significantly improves long-term cardiopulmonary fitness in patients with coronary artery disease (CAD), showing a mean difference of 1.61 in peak oxygen uptake compared to traditional center-based rehabilitation.

Patients participating in cardiac telerehabilitation also experience an improvement in quality of life, with a mean difference of 0.92, while maintaining a high completion rate of 80% and a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. Zhong, W., Liu, R., Cheng, H., et al.[2023]

A scoping meta-review of 80 studies on telerehabilitation (TR) for chronic diseases revealed that the most commonly assessed domains were 'social aspects' and 'clinical efficacy', while 'safety aspects' were rarely evaluated, indicating a gap in safety assessment in TR research.

The review identified that assessments of TR interventions predominantly occurred during pilot studies and randomized trials, suggesting a need for more comprehensive evaluation during all phases of TR development to improve future research and standardization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of the assessment process within telerehabilitation in chronic diseases: a scoping meta-review. Chapel, B., Alexandre, F., Heraud, N., et al.[2022]

The pilot study involving 44 COVID-19 survivors showed that a fully remote telerehabilitation program was safe and feasible, with no serious adverse events reported and a high adherence rate of 93% among participants receiving the intervention.

Both the intervention and control groups experienced meaningful improvements in function and balance, indicating that while the telerehabilitation program was effective, further studies are needed to fully assess its efficacy compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. Capin, JJ., Jolley, SE., Morrow, M., et al.[2023]

Telerehabilitation effectively delivers rehabilitation services to patients in their homes, helping to overcome barriers related to geography, physical limitations, and cognitive challenges.

The rapid advancement of technology has created new applications for telerehabilitation, but there is a need for well-designed studies to establish best practices and ensure its integration into the healthcare system in a cost-effective manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in Rehabilitation. Galea, MD.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06288438

Multicomponent Telerehabilitation to Engage Veterans in ... The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10898211/

Effectiveness of guided telerehabilitation on functional ... To systematically review the effectiveness of guided telerehabilitation on improving functional performance in community-dwelling older adults.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37709508/

Multicomponent telerehabilitation programme for older ... The telerehabilitation programme included four core components: (1) High-intensity rehabilitation, (2) Coaching interventions, (3) Social support and (4) ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/28324897.2024.2340549

Older veteran experiences of using technology during a ... The feasibility trial evaluated a MultiComponent TeleRehabilitation (MCTR) program designed to improve physical function, perceived health, and daily physical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04942613

Engaging Medically Complex Veterans in Tele-Rehabilitation ... The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39777862/

Multicomponent telerehabilitation program for veterans with ... Most in-session safety events were related to underlying medical conditions and consistent with in-person physical rehabilitation safety events.

7. fimt-rc.org fimt-rc.org/article/20230914-multicomponent-telerehabilitation-programme-for-older-veterans-with-multimorbidity-a-programme-evaluation

Multicomponent telerehabilitation programme for older veterans with ... This programme evaluation assessed the safety, feasibility and change in patient outcomes for a multicomponent telerehabilitation programme. Methods ...

8. centreforevidence.org centreforevidence.org/article/20250108-multicomponent-telerehabilitation-program-for-veterans-with-multimorbidity-a-randomized-controlled-feasibility-study

Multicomponent telerehabilitation program for Veterans ... Main Outcome Measures: The primary outcome was combined adherence (>75% of participants attending ≥80% sessions). Acceptability was measured by the ...