An interventional study of Stepped Care in Angina, Stable, Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, sponsored by Peter Lindenauer, MD. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Peter Lindenauer, MD · Not applicable, Interventional, and Supportive care
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.
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.
345 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.
This study's enrollment of 139 is close to the median of 150 across 236 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →This is the only study on the registry with Peter Lindenauer, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Attended pulmonary or cardiac rehabilitation within the previous two years
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.
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
Patients meeting a non-response criterion will be stepped up to the next step
Recruitment
Average number of eligible patients randomized per month
Time frame: 3 years
Adherence
Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions
Time frame: 8 weeks
Adherence
Average number of sessions attended in SC arm
Time frame: 8 weeks
Retention
Proportion in SC arm completing outcome measures
Time frame: 8 weeks
Burden of Data Collection
Baseline Measurement Completion- The investigators need to reach \>80% of baseline data to move forward with this study
Time frame: 8 weeks
PROMIS Dyspnea severity
NIH PROMIS computer adaptive test (CAT) to assess dyspnea severity.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Dyspnea functional limitation
NIH PROMIS CAT to assess dyspnea functional limitation.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Physical function
NIH PROMIS ACT to assess physical function.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Social isolation
NIH PROMIS CAT to assess social isolation.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS anxiety
NIH PROMIS CAT to assess anxiety.
Time frame: 1 week prior to start and 1 week after completion of Rehabilitation
PROMIS Depression/Sadness
NIH PROMIS CAT to assess Depression/Sadness.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PASE
Physical Activity Scale for the elderly. The PASE is a brief, 12-item, reliable, validated questionnaire used to measure physical activity in older adults. Activities are scored using frequency, duration and intensity parameters over the previous week.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
EuroQol (EQ-5D-5L)
Health-related quality of life will be measured using the EuroQol (EQ-5D-5L). The EQ-5D-5L is a well-validated and widely used generic health status questionnaire that measures amount of difficulty with mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Smoking
Smoking will be quantified by self-report (number of cigarettes smoked per day)
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
6 Minute walk test (6-MWT)
The 6-MWT is a widely used and well-validated measure of functional exercise capacity. The 6-MWT measures the distance that a patient can walk quickly on a flat, hard surface over six minutes. It is self-paced and assesses sub-maximal aerobic capacity and endurance.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Short Physical Performance Battery (SPPB)
Physical Function and Mobility will be measured using SPPB which includes a walking speed test, a hierarchal balance test (feet side by side, semi tandem stance, tandem stance), and a 5-times sit to stand test, each scored on a 0-4 scale.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Secondary Feasibility Outcomes
The investigators will look at data already obtained in the research project to determine the number of non-response criteria and average number of days on each step to develop a new protocol for a randomized clinical trial.
Time frame: 3 years
Qualitative feasibility measure
Semi-structured telephone interviews of randomly selected 15 participants to evaluate feasibility of study interventions. Interviews will elicit participants' views and experiences with all aspects of the intervention including personnel, components of the rehabilitation program, data collection procedures, their likes and dislikes about the SC program, and when relevant, reasons for non-adherence. The research staff will also interview the CHW and feedback from RNs to determine the factors that facilitated or impeded the delivery of the intervention and to identify procedures in the protocol which could be improved upon for the full-scale trial.
Time frame: 14 months from the time of first patient enrollment
Plan to share: No — The investigators will adhere to the policy to share data collected by NIH-sponsored research. Investigators will ensure that the mechanisms to share the data are created while safeguarding the privacy of participants and protecting confidential and proprietary data. Prior to sharing, data will be stripped of all identifiers and specific strategies will be employed to minimize the risks of unauthorized disclosure of participants, including indirect information that could lead to deductive disclosure of participants' identities. Even so, in order to ensure protection of subjects, investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.