Stepped Care for Heart & Lung Rehabilitation

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: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This feasibility trial will focus on older adults 60+ who are candidates for cardiac or pulmonary rehabilitation and who are vulnerable, mildly or moderately frail. We will randomize older frail adults living in rural regions of the county to Treatment as usual (TAU) or Stepped care (SC). TAU refers to center-based rehabilitation (CBR). Patients randomized to SC will be enrolled in traditional CBR and based on prespecified non-response criteria, will step up to three services: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR.

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 data supports the idea that Stepped Care for Heart & Lung Rehabilitation is an effective treatment?

The available research shows that Stepped Care for Heart & Lung Rehabilitation is effective because it includes essential components like patient assessment and personalized program content, which lead to improved exercise capacity, better quality of life, and fewer hospital visits. Compared to traditional center-based programs, newer models like home-based rehabilitation have shown similar positive outcomes, making them a viable alternative. This suggests that Stepped Care can be as effective as other rehabilitation methods, especially when tailored to individual needs. ^{1 2 3 4 5}

What safety data is available for Stepped Care in heart and lung rehabilitation?

The provided research does not directly address the safety data for Stepped Care in heart and lung rehabilitation. However, it discusses the benefits and outcomes of cardiac rehabilitation programs, including home-based and center-based models. These studies highlight the effectiveness of cardiac rehabilitation in reducing mortality and improving exercise capacity, but specific safety data for Stepped Care or its variations is not mentioned. ^{6 7 8 9 10}

Is the treatment Stepped Care for Heart & Lung Rehabilitation promising?

Yes, the Stepped Care treatment for Heart & Lung Rehabilitation is promising because it combines different levels of care to improve access and effectiveness. It can help people with heart and lung issues by offering personalized and flexible rehabilitation options, which can lead to better health outcomes like improved exercise ability and quality of life. ^{1 7 11 12 13}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. [2021]

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

Measuring behavioral outcomes in cardiopulmonary rehabilitation: AN AACVPR STATEMENT. [2019]

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

A Comparative Effectiveness Review: RESPONSIVENESS OF PATIENT OUTCOME MEASURES IN CARDIAC AND PULMONARY REHABILITATION. [2020]

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

Feasibility of a multi-state outcomes program for cardiopulmonary rehabilitation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. [2022]

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

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. [2020]

7. England 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. [2023]

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

Cardiac rehabilitation: a contemporary review. [2016]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Obesity Related Index and Exercise Capacity Between Center-Based and Home-Based Cardiac Rehabilitation Programs. [2020]

10. Portugal pubmed.ncbi.nlm.nih.gov

Digital home-based multidisciplinary cardiac rehabilitation: How to counteract physical inactivity during the COVID-19 pandemic. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Process of pulmonary rehabilitation and program organization. [2011]

12. England pubmed.ncbi.nlm.nih.gov

Perspective of Pulmonary Rehabilitation Centers in Latin America. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

[Efficacy of pulmonary rehabilitation]. [2011]