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

NCT05562037 | Completed DMC

• 1 other identifier: R34HL156920
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Average number of eligible patients randomized per month

  3 years

• Adherence

  Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions

  8 weeks

• Adherence

  Average number of sessions attended in SC arm

  8 weeks

• Retention

  Proportion in SC arm completing outcome measures

  8 weeks

• Burden of Data Collection

  Baseline Measurement Completion- The investigators need to reach \>80% of baseline data to move forward with this study

  8 weeks

Secondary Outcomes (11)

• PROMIS Dyspnea severity

  1 week prior to start and 1 week after completion of rehabilitation

• PROMIS Dyspnea functional limitation

  1 week prior to start and 1 week after completion of rehabilitation

• PROMIS Physical function

  1 week prior to start and 1 week after completion of rehabilitation

• PROMIS Social isolation

  1 week prior to start and 1 week after completion of rehabilitation

• PROMIS anxiety

  1 week prior to start and 1 week after completion of Rehabilitation

Other Outcomes (2)

• Secondary Feasibility Outcomes

  3 years

• Qualitative feasibility measure

  14 months from the time of first patient enrollment

Study Arms (2)

Treatment as usual

NO 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.

Stepped Care

ACTIVE COMPARATOR

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.

Other: Stepped Care

Interventions

Stepped Care OTHER

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

Stepped Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Peter Lindenauer, MD: lead
• Berkshire Medical Center: collaborator

Study Sites (2)

Berkshire Medical Center, Inc

Pittsfield, Massachusetts, 01201, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be obtained by a blinded research assistant over the phone within 1 week of completing the 8 week rehabilitation program
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The planned research is to improve enrollment, adherence and completion of CR and PR using stepped care (SC). The proposed SC model enables a patient-centered approach by matching intensity of treatment with individual patient needs.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: September 30, 2022
• Study Start: September 8, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)