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

Trial Summary

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 data supports the effectiveness of the treatment Multicomponent Telerehabilitation?

Research shows that telerehabilitation can be effective for stroke survivors and patients with coronary artery disease, offering a flexible and accessible way to receive care from home. It helps maintain therapeutic relationships and provides strategies to prevent functional decline, making it a promising option for managing multiple health conditions. ^{1 2 3 4 5}

How is the Multicomponent Telerehabilitation treatment different from other treatments for multi-morbidity?

Multicomponent Telerehabilitation is unique because it allows patients to receive rehabilitation care remotely, making it more accessible and flexible compared to traditional in-person treatments. This approach has been successfully used for conditions like stroke and coronary artery disease, offering a novel way to manage chronic diseases from a distance. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Jennifer E. Stevens-Lapsley, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

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

Life expectancy < 12 months

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Standardization of the assessment process within telerehabilitation in chronic diseases: a scoping meta-review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in Rehabilitation. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Telerehabilitation for Stroke Survivors: Systematic Review and Meta-Analysis. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transition to Multidisciplinary Pediatric Telerehabilitation during the COVID-19 Pandemic: Strategy Development and Implementation. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of Muvity: A telerehabilitation system for chronic post-stroke subjects. [2022]

7. England 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. [2023]