Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rura… (NCT05562037) | Clinical Trial Compass
CompletedNot Applicable
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
United States139 participantsStarted 2022-09-08
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cardi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.