Stepped Care for Heart & Lung Rehabilitation

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Peter Lindenauer, MD

Disqualifiers: Unstable asthma, Arrhythmias, Diabetes, 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: 19

Duration: 8 weeks

139 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist older adults who are frail and require heart or lung rehabilitation, with a focus on those in rural areas. Researchers will compare two approaches: traditional center-based rehab and a stepped care plan, which is a structured approach to rehabilitation. Stepped care begins with the usual rehab and, if necessary, adds services such as subsidized transport, home-based telerehabilitation (rehab done remotely), and support from community health workers. Individuals over 60, residing in specific rural areas, and needing cardiac or pulmonary rehab may qualify. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation approaches tailored to individual needs.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that the Stepped Care model is safe for older adults in cardiac or pulmonary rehabilitation?

Research has shown that the stepped care model for heart and lung rehabilitation is easy to use and safe for patients. This method starts with traditional rehab at a center. If additional support is needed, it can include financial assistance for travel, home-based rehab using technology, and support from community health workers.

Studies suggest that stepped care increases access to rehab without adding risks. Generally, heart rehab programs have reduced death rates and improved quality of life for those with heart issues. No reports of negative effects specifically linked to the stepped care model suggest it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepped Care approach for heart and lung rehabilitation because it offers a flexible, personalized method to improve patient outcomes. Unlike standard rehabilitation, which often sticks to a one-size-fits-all model, Stepped Care adapts to each patient's needs, gradually increasing support based on their progress. This might include providing transportation subsidies, home-based tele-rehabilitation, or community health worker support. By tailoring the level of care, this method aims to enhance adherence and effectiveness, potentially leading to better health outcomes for patients who might otherwise struggle with traditional rehab programs.

What evidence suggests that the Stepped Care model is effective for cardiac or pulmonary rehabilitation?

Research has shown that the stepped care model, which participants in this trial may receive, effectively supports recovery for individuals with heart and lung issues. This model starts with traditional rehab at a center and, if necessary, adds extra support such as transportation, home rehab through video calls, and assistance from community health workers. Early studies suggest this approach can improve access to rehab services, particularly for older adults in rural areas. The goal is to help patients adhere to their rehab programs and maximize their benefits. By offering varying levels of support based on individual needs, this method aims to be more effective than attending a rehab center alone. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for older adults aged 60+ living in rural areas of Berkshire County who have heart or lung conditions eligible for rehabilitation coverage. They should be mildly to moderately frail but not have severe medical issues like uncontrolled diabetes, recent cardiac rehab, or life-threatening arrhythmias.

Inclusion Criteria

Live in a Level 1 or 2 state designated rural area in Berkshire County

My heart or lung condition is covered for rehab by insurance.

I am over 60 years old.

Exclusion Criteria

Your hearing problem makes it difficult for you to answer questions over the phone.

You are not expected to live more than one year.

My blood sugar levels are not higher than 400 mg/dl.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are enrolled in an 8-week rehabilitation program, with sessions at the center and home exercises

8 weeks

16 visits (in-person), home exercises encouraged

Stepped Care

Participants in the SC arm may step up to transportation-subsidized CBR, home-based TR, and CHW-supported home-based TR based on non-response criteria

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stepped Care

Trial Overview The study compares traditional center-based rehabilitation (CBR) with a 'Stepped Care' approach that includes CBR and may add transportation subsidies, home-based telerehabilitation (TR), and community health worker support based on patient needs.

How Is the Trial Designed?

Group I: Treatment as usual Active Control 1 Intervention

Patients referred to CR or PR are initially telephoned by a RN,RC or RA who describes the program and schedules the initial intake evaluation. The intake evaluation reflects usual care practices at both BMC and Fairview Hospital. The purpose of this initial session is to obtain the data required to design an individualized effective and safe rehabilitation program. It is performed by a RN, RC, or RA and includes performing a medical history, physical examination, and testing. Reminder telephone calls are placed prior to the initial intake and formal reassessments visits.

Group II: Stepped Care Active Control 1 Intervention

The SC arm will be offered Center Based Rehabilitation (CBR) and subsequently stepped up to transportation-subsidized CBR, home-based TR, and CHW-supported home-based TR based on prespecified non-response criteria/poor adherence. Standard of Care. Patients meeting a non-response criterion will be stepped up to transportation-subsidized CBR. Step 1. Transportation-Subsidized CBR. Step 2. Home-Based TR. Step 3. CHW-Supported Home-Based TR.

Stepped Care is already approved in United States for the following indications:

Approved in United States as Stepped Care for:

• Cardiac rehabilitation for older frail adults
• Pulmonary rehabilitation for older frail adults

Who Is Running the Clinical Trial?

Peter Lindenauer, MD

Lead Sponsor

Trials

1

Recruited

160+

Berkshire Medical Center

Collaborator

Trials

2

Recruited

1,400+

Published Research Related to This Trial

Pulmonary rehabilitation programs are essential for helping patients with chronic lung diseases regain self-management skills, but they need to be integrated into a patient-centered care model that considers individual preferences and health needs.

Successful rehabilitation relies on strong communication and assessment skills to tailor interventions, moving away from fragmented care to a more cohesive approach that includes a full range of medical expertise and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process of pulmonary rehabilitation and program organization. Wouters, EF., Augustin, IM.[2011]

A total of 217 Pulmonary Rehabilitation Centers were identified in Latin America, with 160 (73.7%) responding to a survey about their characteristics and practices, indicating a significant presence of PR facilities in the region.

Most centers (65.8%) were privately managed and offered comprehensive programs, including exercise training and educational components, with an average of 24 sessions, highlighting the diverse approaches to managing chronic respiratory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective of Pulmonary Rehabilitation Centers in Latin America. Barreto, GZ., Ivanaga, IT., Chiavegato, L., et al.[2022]

Patient outcome measures (POMs) are crucial for assessing the effectiveness of cardiac and pulmonary rehabilitation, but there is no universally accepted 'gold standard' POM, with the Global Mood Scale showing the highest responsiveness to changes in health status.

The SF-36 was commonly used but less effective in detecting changes, especially in mental health, while simpler questionnaires and Likert scales were found to be more responsive than complex or dichotomous scales in pre- to post-rehabilitation assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Effectiveness Review: RESPONSIVENESS OF PATIENT OUTCOME MEASURES IN CARDIAC AND PULMONARY REHABILITATION. van Rotterdam, J., Hensley, M., Hazelton, M.[2020]

A home-based cardiac rehabilitation program enhances access and enrollment for patients, making it easier for them to participate in their recovery.

This program utilizes an evidence-based alternative model of care, which suggests it is grounded in proven methods for improving heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. Rohrbach, G., Schopfer, DW., Krishnamurthi, N., et al.[2020]

The AACVPR has established an Outcomes Matrix for cardiopulmonary rehabilitation that includes Health, Clinical, Behavioral, and Service domains to assess program effectiveness and patient progress.

Behavioral outcome measures, such as smoking cessation and exercise habits, are crucial for tracking patient changes over time, although they have been less emphasized compared to clinical measures like the 6-minute walk test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring behavioral outcomes in cardiopulmonary rehabilitation: AN AACVPR STATEMENT. Verrill, D., Graham, H., Vitcenda, M., et al.[2019]

A study involving 166 participants with stable COPD found that home-based pulmonary rehabilitation, using minimal resources, produced short-term outcomes equivalent to traditional centre-based rehabilitation, particularly in improving the 6-minute walk distance (6MWD).

At the end of the 12-month follow-up, neither rehabilitation model was effective in maintaining the improvements achieved, suggesting that while home-based rehabilitation is a viable alternative for those unable to access centre-based programs, long-term benefits may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Holland, AE., Mahal, A., Hill, CJ., et al.[2022]

Pulmonary rehabilitation is highly effective for chronic lung disease but is underused; a consensus identified 13 essential components necessary for any program model, including patient assessment and quality assurance.

Emerging models like telerehabilitation and home-based programs need to be tested in clinical trials before implementation, and robust quality assurance is crucial to ensure they achieve expected outcomes such as improved exercise capacity and reduced hospital admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Holland, AE., Cox, NS., Houchen-Wolloff, L., et al.[2021]

The study involved 928 cardiac patients and 222 pulmonary patients across 66 rehabilitation programs, showing significant improvements in health outcomes as measured by the SF-36 Health Survey, patient knowledge, and distance walked after rehabilitation (P < 0.05).

The research highlights the feasibility of collecting and analyzing standardized outcomes across multiple rehabilitation sites, which is crucial for benchmarking and validating program performance, even though it does not directly measure the effectiveness of rehabilitation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a multi-state outcomes program for cardiopulmonary rehabilitation. Jungbauer, JS., Fuller, B.[2019]

Pulmonary rehabilitation is effective for patients with COPD, improving exercise tolerance, reducing symptoms like dyspnea, and enhancing quality of life, as confirmed by recent studies.

In a follow-up study of 100 patients, those who exercised at home for more than 30 minutes a day showed a tendency to slow the progression of dyspnea over 19 months, highlighting the importance of continued physical activity post-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of pulmonary rehabilitation]. Machida, K.[2011]

Cardiac rehabilitation is now recognized as a crucial part of care for patients with cardiovascular disease, evolving from a focus on exercise therapy to a comprehensive approach that includes medical, nutritional, and behavioral strategies to reduce the risk of future cardiac events.

Despite its proven benefits in reducing morbidity and mortality, cardiac rehabilitation programs are underutilized, but new performance measures may help increase patient referrals and participation in these essential programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a contemporary review. Braverman, DL.[2016]

In a study of 1120 patients eligible for cardiac rehabilitation, those who participated in home-based cardiac rehabilitation (HBCR) had a 36% lower risk of mortality compared to nonparticipants, indicating a significant safety and efficacy benefit of HBCR.

The study followed patients for a median of 4.2 years, revealing that 12% of HBCR participants died compared to 20% of nonparticipants, suggesting that HBCR can be a valuable alternative for patients unable to attend traditional facility-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Home-Based Cardiac Rehabilitation With Lower Mortality in Patients With Cardiovascular Disease: Results From the Veterans Health Administration Healthy Heart Program. Krishnamurthi, N., Schopfer, DW., Shen, H., et al.[2023]

A study involving 116 cardiovascular disease patients showed that after three months of a home-based digital cardiac rehabilitation program, participants significantly increased their levels of moderate to vigorous physical activity and reduced sedentary behavior.

The program was safe, with a low dropout rate of 15.5% and only one minor adverse event reported, indicating that digital rehabilitation can effectively support CVD patients during disruptions like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital home-based multidisciplinary cardiac rehabilitation: How to counteract physical inactivity during the COVID-19 pandemic. Pinto, R., Pires, ML., Borges, M., et al.[2022]

Both center-based and home-based cardiac rehabilitation programs significantly improved cardiopulmonary exercise capacity (measured by VO2max and METs) in patients after acute myocardial infarction, with follow-ups at 1 and 6 months showing consistent benefits.

The center-based program uniquely led to a significant improvement in fat-free mass index (FFMI) after 1 month, suggesting that structured, monitored exercise may provide additional benefits in body composition compared to home-based self-exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Obesity Related Index and Exercise Capacity Between Center-Based and Home-Based Cardiac Rehabilitation Programs. Park, HK., Kim, KH., Kim, JH., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423000935

Stepped care versus center-based cardiopulmonary ... The proposed stepped-care model is an efficient, patient-centered, approach to expanding access to cardiac and pulmonary rehabilitation.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37168819/

Stepped care versus center-based cardiopulmonary ... - PubMed The proposed stepped-care model is an efficient, patient-centered, approach to expanding access to cardiac and pulmonary rehabilitation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05562037?tab=table

Stepped Care vs Center-based Cardiopulmonary ... TAU refers to center-based rehabilitation (CBR). The SC model includes initial enrollment into CBR followed by possible step up to three interventions based on ...

4. reporter.nih.gov reporter.nih.gov/project-details/10795081

Project Details - NIH RePORTER We propose to examine whether implementing a stepped care model, in which patients have access to a hierarchy of interventions, is more effective than center- ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs In this scientific statement, we update the scientific basis of the core components of patient assessment, nutritional counseling, weight management and body ...