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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Uncontrolled diabetes (resting blood glucose >400 mg/dl)
Significant cognitive deficit and/or psychiatric illness that interferes with ability to provide consent, follow directions, or adhere to study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Summary
This trial will focus on older adults who are candidates for cardiac or pulmonary rehabilitation and who are vulnerable, mildly or moderately frail. The goal is to see if stepped care, which includes traditional center-based rehabilitation as well as transportation-subsidized CBR, home-based telerehabilitation, and community health worker-supported home-based telerehabilitation, is more effective than treatment as usual.
Who is the study for?
This trial is for older adults aged 60+ living in rural areas of Berkshire County who have heart or lung conditions eligible for rehabilitation coverage. They should be mildly to moderately frail but not have severe medical issues like uncontrolled diabetes, recent cardiac rehab, or life-threatening arrhythmias.
What is being tested?
The study compares traditional center-based rehabilitation (CBR) with a 'Stepped Care' approach that includes CBR and may add transportation subsidies, home-based telerehabilitation (TR), and community health worker support based on patient needs.
What are the potential side effects?
Since the interventions involve different forms of rehabilitation care rather than medication, side effects are minimal but could include typical exercise-related risks such as muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart or lung condition is covered for rehab by insurance.
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I am considered vulnerable to moderately frail according to the Clinical Frailty Scale.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood sugar levels are not higher than 400 mg/dl.
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I do not have any mental health issues that prevent me from understanding or following study instructions.
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I have irregular heartbeats from the lower chambers of my heart.
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I am scheduled for surgery or a transplant.
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I have unstable chest pain.
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I have heart failure that is not well-managed.
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I do not have active inflammation of the heart.
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I have severe lung blood pressure or heart issues due to lung conditions.
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I have had fainting spells due to an irregular heartbeat.
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My oxygen levels are below 85% without extra oxygen or with my usual extra oxygen.
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I have been to lung or heart rehab in the last 2 years.
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I have had a severe asthma attack requiring hospital or ED visit in the last 3 months.
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I do not have a fever or any sudden illness.
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I experience severe shortness of breath during exercise that oxygen doesn't help.
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I do not have uncontrolled irregular heartbeats.
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My blood pressure drops significantly when I stand up, causing symptoms.
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I have severe heart valve symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence
Burden of Data Collection
Recruitment
+1 moreSecondary study objectives
6 Minute walk test (6-MWT)
EuroQol (EQ-5D-5L)
PASE
+8 moreOther study objectives
Secondary Feasibility Outcomes
Trial Design
2Treatment groups
Active Control
Group I: Treatment as usualActive Control1 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.
Group II: Stepped CareActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Peter Lindenauer, MDLead Sponsor
Berkshire Medical CenterOTHER
1 Previous Clinical Trials
1,288 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hearing problem makes it difficult for you to answer questions over the phone.My heart or lung condition is covered for rehab by insurance.You are not expected to live more than one year.My blood sugar levels are not higher than 400 mg/dl.I do not have any mental health issues that prevent me from understanding or following study instructions.I am over 60 years old.I have irregular heartbeats from the lower chambers of my heart.I am scheduled for surgery or a transplant.I have unstable chest pain.I have heart failure that is not well-managed.I do not have active inflammation of the heart.I have severe lung blood pressure or heart issues due to lung conditions.Your heart's resting position shows a displacement of more than 2mm.I have had fainting spells due to an irregular heartbeat.You have a severe heart block without a pacemaker.My oxygen levels are below 85% without extra oxygen or with my usual extra oxygen.I have been to lung or heart rehab in the last 2 years.I have had a severe asthma attack requiring hospital or ED visit in the last 3 months.I do not have a fever or any sudden illness.I experience severe shortness of breath during exercise that oxygen doesn't help.I do not have conditions like severe arthritis or liver/kidney diseases that prevent me from exercising.I do not have uncontrolled irregular heartbeats.My blood pressure drops significantly when I stand up, causing symptoms.I am considered vulnerable to moderately frail according to the Clinical Frailty Scale.Your blood pressure when you are not active is higher than 200mmHg.Your diastolic blood pressure when you are resting is higher than 100mmHg.I have severe heart valve symptoms.Your heart beats too fast, more than 120 times per minute, and it cannot be controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as usual
- Group 2: Stepped Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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