Angina, StableNCT05562037
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
A study testing Stepped Care in people with Angina, Stable and Congestive Heart Failure, run by Peter Lindenauer, MD at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Angina, Stable, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Stepped Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2022to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Berkshire Medical Center, Inc
Pittsfield, Massachusetts, 01201
Baystate Health
Springfield, Massachusetts, 01199
About this study
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.
Read the 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.
- Being tested
- Stepped Care
- Medical subject headings
- Angina, Stable, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareOther
Patients meeting a non-response criterion will be stepped up to the next step
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Stepped Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Average number of eligible patients randomized per month
Measured: 3 years
Adherence
Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions
Measured: 8 weeks
Adherence
Average number of sessions attended in SC arm
Measured: 8 weeks
Retention
Proportion in SC arm completing outcome measures
Measured: 8 weeks
Burden of Data Collection
Baseline Measurement Completion- The investigators need to reach >80% of baseline data to move forward with this study
Measured: 8 weeks
Secondary outcomes (11)
PROMIS Dyspnea severity
NIH PROMIS computer adaptive test (CAT) to assess dyspnea severity.
Measured: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Dyspnea functional limitation
NIH PROMIS CAT to assess dyspnea functional limitation.
Measured: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Physical function
NIH PROMIS ACT to assess physical function.
Measured: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Social isolation
NIH PROMIS CAT to assess social isolation.
Measured: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS anxiety
NIH PROMIS CAT to assess anxiety.
Measured: 1 week prior to start and 1 week after completion of Rehabilitation
PROMIS Depression/Sadness
NIH PROMIS CAT to assess Depression/Sadness.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 1 week prior to start and 1 week after completion of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start8 Sep 2022
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Lindenauer, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Berkshire Medical Center
- Responsible party
- Sponsor-investigator, Peter Lindenauer, MD, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562037
- Sponsor's protocol ID
- R34HL156920
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pub5.
PubMed 30695817Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
PubMed 26730878Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
PubMed 27930803Lindenauer PK, Stefan MS, Pekow PS, Mazor KM, Priya A, Spitzer KA, Lagu TC, Pack QR, Pinto-Plata VM, ZuWallack R. Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries. JAMA. 2020 May 12;323(18):1813-1823. doi: 10.1001/jama.2020.4437.
PubMed 32396181Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2016 Mar-Apr;36(2):75-83. doi: 10.1097/HCR.0000000000000171.
PubMed 26906147Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
PubMed 26623686Drozda J Jr, Messer JV, Spertus J, Abramowitz B, Alexander K, Beam CT, Bonow RO, Burkiewicz JS, Crouch M, Goff DC Jr, Hellman R, James T 3rd, King ML, Machado EA Jr, Ortiz E, O'Toole M, Persell SD, Pines JM, Rybicki FJ, Sadwin LB, Sikkema JD, Smith PK, Torcson PJ, Wong JB; American Academy of Family Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; American Association of Clinical Endocrinologists; American College of Emergency Physicians; American College of Radiology; American Nurses Association; American Society of Health-System Pharmacists; Society of Hospital Medicine; Society of Thoracic Surgeons. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with coronary artery disease and hypertension: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2011 Jul 12;58(3):316-36. doi: 10.1016/j.jacc.2011.05.002. Epub 2011 Jun 14. No abstract available.
PubMed 21676572American Academy of Family Physicians; American Academy of Hospice and Palliative Medicine; American Nurses Association; American Society of Health-System Pharmacists; Heart Rhythm Society; Society of Hospital Medicine; Bonow RO, Ganiats TG, Beam CT, Blake K, Casey DE Jr, Goodlin SJ, Grady KL, Hundley RF, Jessup M, Lynn TE, Masoudi FA, Nilasena D, Pina IL, Rockswold PD, Sadwin LB, Sikkema JD, Sincak CA, Spertus J, Torcson PJ, Torres E, Williams MV, Wong JB; ACCF/AHA Task Force on Performance Measures; Peterson ED, Masoudi FA, DeLong E, Erwin JP 3rd, Fonarow GC, Goff DC Jr, Grady KL, Green LA, Heidenreich PA, Jenkins KJ, Loth A, Shahian DM. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2012 May 15;59(20):1812-32. doi: 10.1016/j.jacc.2012.03.013. Epub 2012 Apr 23. No abstract available.
PubMed 22534627Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. doi: 10.1016/j.jacc.2007.02.013. No abstract available.
PubMed 17692738O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):485-510. doi: 10.1016/j.jacc.2012.11.018. Epub 2012 Dec 17. No abstract available.
PubMed 23256913Rubin R. Although Cardiac Rehab Saves Lives, Few Eligible Patients Take Part. JAMA. 2019 Aug 6;322(5):386-388. doi: 10.1001/jama.2019.8604. No abstract available.
PubMed 31314061Arena R, Williams M, Forman DE, Cahalin LP, Coke L, Myers J, Hamm L, Kris-Etherton P, Humphrey R, Bittner V, Lavie CJ; American Heart Association Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity and Metabolism. Increasing referral and participation rates to outpatient cardiac rehabilitation: the valuable role of healthcare professionals in the inpatient and home health settings: a science advisory from the American Heart Association. Circulation. 2012 Mar 13;125(10):1321-9. doi: 10.1161/CIR.0b013e318246b1e5. Epub 2012 Jan 30. No abstract available.
PubMed 22291128Nishi SP, Zhang W, Kuo YF, Sharma G. Pulmonary Rehabilitation Utilization in Older Adults With Chronic Obstructive Pulmonary Disease, 2003 to 2012. J Cardiopulm Rehabil Prev. 2016 Sep-Oct;36(5):375-82. doi: 10.1097/HCR.0000000000000194.
PubMed 27428819Spitzer KA, Stefan MS, Priya A, Pack QR, Pekow PS, Lagu T, Pinto-Plata VM, ZuWallack RL, Lindenauer PK. Participation in Pulmonary Rehabilitation after Hospitalization for Chronic Obstructive Pulmonary Disease among Medicare Beneficiaries. Ann Am Thorac Soc. 2019 Jan;16(1):99-106. doi: 10.1513/AnnalsATS.201805-332OC.
PubMed 30417670Vercammen-Grandjean C, Schopfer DW, Zhang N, Whooley MA. Participation in Pulmonary Rehabilitation by Veterans Health Administration and Medicare Beneficiaries After Hospitalization for Chronic Obstructive Pulmonary Disease. J Cardiopulm Rehabil Prev. 2018 Nov;38(6):406-410. doi: 10.1097/HCR.0000000000000357.
PubMed 30252780
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
- ClinicalTrials.gov ID
- NCT05562037
- Acronym / sponsor ID
- R34HL156920
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Peter Lindenauer, MDUniversity, hospital or other
- Collaborators
- Berkshire Medical Center
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Stepped CareThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped CarePatients meeting a non-response criterion will be stepped up to the next step | Other | Stepped Care |
Primary outcome
Recruitment
Time frame: 3 years
Average number of eligible patients randomized per month
Adherence
Time frame: 8 weeks
Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions
Adherence
Time frame: 8 weeks
Average number of sessions attended in SC arm
Retention
Time frame: 8 weeks
Proportion in SC arm completing outcome measures
Burden of Data Collection
Time frame: 8 weeks
Baseline Measurement Completion- The investigators need to reach >80% of baseline data to move forward with this study
11 secondary outcomes
PROMIS Dyspnea severity
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Dyspnea functional limitation
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Physical function
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Social isolation
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS anxiety
Time frame: 1 week prior to start and 1 week after completion of Rehabilitation
PROMIS Depression/Sadness
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PASE
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
EuroQol (EQ-5D-5L)
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Smoking
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
6 Minute walk test (6-MWT)
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Short Physical Performance Battery (SPPB)
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Results publication: PubMed 30695817Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pub5.
- Results publication: PubMed 26730878Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
- Results publication: PubMed 27930803Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
- Results publication: PubMed 32396181Lindenauer PK, Stefan MS, Pekow PS, Mazor KM, Priya A, Spitzer KA, Lagu TC, Pack QR, Pinto-Plata VM, ZuWallack R. Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries. JAMA. 2020 May 12;323(18):1813-1823. doi: 10.1001/jama.2020.4437.
- Results publication: PubMed 26906147Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2016 Mar-Apr;36(2):75-83. doi: 10.1097/HCR.0000000000000171.
- Results publication: PubMed 26623686Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
- Results publication: PubMed 21676572Drozda J Jr, Messer JV, Spertus J, Abramowitz B, Alexander K, Beam CT, Bonow RO, Burkiewicz JS, Crouch M, Goff DC Jr, Hellman R, James T 3rd, King ML, Machado EA Jr, Ortiz E, O'Toole M, Persell SD, Pines JM, Rybicki FJ, Sadwin LB, Sikkema JD, Smith PK, Torcson PJ, Wong JB; American Academy of Family Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; American Association of Clinical Endocrinologists; American College of Emergency Physicians; American College of Radiology; American Nurses Association; American Society of Health-System Pharmacists; Society of Hospital Medicine; Society of Thoracic Surgeons. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with coronary artery disease and hypertension: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2011 Jul 12;58(3):316-36. doi: 10.1016/j.jacc.2011.05.002. Epub 2011 Jun 14. No abstract available.
- Results publication: PubMed 22534627American Academy of Family Physicians; American Academy of Hospice and Palliative Medicine; American Nurses Association; American Society of Health-System Pharmacists; Heart Rhythm Society; Society of Hospital Medicine; Bonow RO, Ganiats TG, Beam CT, Blake K, Casey DE Jr, Goodlin SJ, Grady KL, Hundley RF, Jessup M, Lynn TE, Masoudi FA, Nilasena D, Pina IL, Rockswold PD, Sadwin LB, Sikkema JD, Sincak CA, Spertus J, Torcson PJ, Torres E, Williams MV, Wong JB; ACCF/AHA Task Force on Performance Measures; Peterson ED, Masoudi FA, DeLong E, Erwin JP 3rd, Fonarow GC, Goff DC Jr, Grady KL, Green LA, Heidenreich PA, Jenkins KJ, Loth A, Shahian DM. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2012 May 15;59(20):1812-32. doi: 10.1016/j.jacc.2012.03.013. Epub 2012 Apr 23. No abstract available.
- Results publication: PubMed 17692738Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. doi: 10.1016/j.jacc.2007.02.013. No abstract available.
- Results publication: PubMed 23256913O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):485-510. doi: 10.1016/j.jacc.2012.11.018. Epub 2012 Dec 17. No abstract available.
- Results publication: PubMed 31314061Rubin R. Although Cardiac Rehab Saves Lives, Few Eligible Patients Take Part. JAMA. 2019 Aug 6;322(5):386-388. doi: 10.1001/jama.2019.8604. No abstract available.
- Results publication: PubMed 22291128Arena R, Williams M, Forman DE, Cahalin LP, Coke L, Myers J, Hamm L, Kris-Etherton P, Humphrey R, Bittner V, Lavie CJ; American Heart Association Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity and Metabolism. Increasing referral and participation rates to outpatient cardiac rehabilitation: the valuable role of healthcare professionals in the inpatient and home health settings: a science advisory from the American Heart Association. Circulation. 2012 Mar 13;125(10):1321-9. doi: 10.1161/CIR.0b013e318246b1e5. Epub 2012 Jan 30. No abstract available.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care in people with Angina, Stable and Congestive Heart Failure, run by Peter Lindenauer, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562037, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.