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

Completed · Not applicable

Conditions studied: Angina, Stable, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT05562037

Run by

Peter Lindenauer, MD

People needed

139

Starts

2022-09-08

Expected to finish

2025-03-30

Last updated by the study team

2025-07-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Berkshire Medical Center, Inc — Pittsfield, Massachusetts, United States
• Baystate Health — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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