Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

NCT ID: NCT05562037

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2025-03-30

Brief Summary

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. The investigators 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.

Detailed Description

Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients with heart and lung disease living in rural communities have even lower rates of participation.

The objective of this proposal is to test the feasibility of performing a full-scale randomized controlled trial (RCT) to compare the effectiveness and value of a stepped care (SC) model versus treatment as usual (TAU) in older frail adults living rural counties. 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 prespecified non-response criteria: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR. Unlike traditional SC models, the initial treatment in this model, i.e. CBR, is not the least resource intensive. CBR was chosen as the initial option because it is currently considered the standard of care.

The investigators will conduct a parallel, 2-arm, randomized controlled feasibility trial. Eligible participants will be randomized to TAU (CBR) or SC. Because of the urgent need to address underuse of both CR and PR in rural regions, the proposed feasibility trial will enroll patients referred to either CR or PR. Both arms include an in-person intake evaluation conducted by a certified rehabilitation nurse in the rehabilitation center to determine exercise tolerance and design a tailored 8-week rehabilitation program. Patients randomized to TAU participate in two weekly sessions at the center and are encouraged to exercise at home in between sessions. Patients randomized to the SC arm will also be enrolled in the CBR program. Those who meet prespecified non-response criteria will be stepped up to transportation-subsidized CBR. Providing transportation may not be sufficient for frail older adults who are reluctant to leave their homes in the winter, unfamiliar with exercising, or do not want to exercise in a group setting. Thus, non-responders, will be stepped up to home-based TR. Home-based rehabilitation will be supported by Chanl Health, a virtual platform that supports education and self-management, remote monitoring, and coaching by rehabilitation specialists. Non-responders will be stepped up to CHW-supported home-based TR. The CHW will be help participants use the mobile app, access educational materials, clarify educational content, and exercise during biweekly in-person visits.

Purpose: Heart and lung disease are the first and third leading causes of mortality in the US, respectively. Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients living in rural communities have even lower rates of participation. Home-based CR and PR has been developed with the goal of improving uptake, and low to moderate strength evidence indicates that these programs are as effective as center-based programs. Further work is needed, however, to examine how best to increase utilization of CR and PR in rural communities. While several studies have examined approaches to improve referral and enrollment, there is little evidence on how to optimize adherence to CR, and no evidence how to optimize adherence to PR.

Conditions

Angina, Stable; Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Treatment as usual

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 Type: NO_INTERVENTION

No interventions assigned to this group

Stepped Care

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.

Group Type: ACTIVE_COMPARATOR

Stepped Care

Intervention Type: OTHER

Patients meeting a non-response criterion will be stepped up to the next step

Interventions

Stepped Care

Patients meeting a non-response criterion will be stepped up to the next step

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older adults (greater than 60 years of age)
• Live in a Level 1 or 2 state designated rural area in Berkshire County
• Has a condition qualifying for reimbursement (by government or private insurance) for cardiac or pulmonary rehabilitation
• Score of 4, 5 or 6 on the Clinical Frailty Scale(24) (corresponding to vulnerable, mildly frail, and moderately frail)

Exclusion Criteria

Attended pulmonary or cardiac rehabilitation within the previous two years

• Resting pulse oximetry < 85% on room air or while breathing the prescribed level of supplemental oxygen
• Unstable asthma with hospital admission or ED visit within previous three months
• Severe exercise-induced hypoxemia, not correctable with oxygen supplementation
• Acute systemic illness or fever
• Complex ventricular arrhythmias
• Resting systolic blood pressure greater than 200mmhg
• Resting diastolic blood pressure greater than 100mmhg
• Orthostatic blood pressure (BP) drop of >20 mm Hg with symptoms
• History of arrhythmia with syncope
• Severe symptomatic valvular disease
• Unstable angina
• Uncontrolled atrial or ventricular arrhythmias
• Uncontrolled sinus tachycardia (>120 BPM)
• Uncompensated congestive heart failure
• Third degree heart block without a pacemaker
• Active pericarditis or myocarditis
• Acute cor pulmonale, severe pulmonary hypertension
• Resting ST displacement > 2mm
• Uncontrolled diabetes (resting blood glucose >400 mg/dl)
• Conditions other than pulmonary or cardiac that prohibit exercise (e.g., arthritis, severe neurologic, hepatic or renal disease)
• Planned surgery or transplantation
• Hearing impairment limiting ability to participate in data collection by telephone
• Life expectancy less than one year
• Significant cognitive deficit and/or psychiatric illness that interferes with ability to provide consent, follow directions, or adhere to study procedures
• referral to cardiac rehab after coronary artery bypass graph (CABG) and valvular surgery

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berkshire Medical Center

OTHER

Sponsor Role: collaborator

Peter Lindenauer, MD

OTHER

Sponsor Role: lead

Responsible Party

Peter Lindenauer, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Berkshire Medical Center, Inc

Pittsfield, Massachusetts, United States

Baystate Health

Springfield, Massachusetts, United States

Countries

United States

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Other Identifiers

R34HL156920

Identifier Type: NIH

Identifier Source: org_study_id

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