Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am considered vulnerable to moderately frail according to the Clinical Frailty Scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Burden of Data Collection
Recruitment
+1 moreSecondary outcome measures
6 Minute walk test (6-MWT)
EuroQol (EQ-5D-5L)
PASE
+8 moreOther outcome measures
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited for this research experiment?
"Indeed, clinicaltrials.gov has documented that this medical experiment is actively recruiting participants; the trial was posted on September 8th 2022 and last modified on October 19th 2022. Two sites are looking to enrol 120 patients."
Answered by AI
Are there opportunities available for individuals to participate in this scientific experiment?
"Confirmed by clinicaltrials.gov, this study is presently recruiting participants for the trial that began on September 8th 2022 and was most recently modified on October 19th 2022."
Answered by AI
What is the primary focus of this exploration?
"This long-term clinical trial seeks to measure Adherence as its primary outcome after a duration of three years. Secondary goals include quantifying Smoking via self-reported data, and utilizing NIH PROMIS CAT scales to evaluate Social Isolation and Depression/Sadness."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've been struggling with th I s for a few years and nothing has helped. I keep going down the rabbit hole.
PatientReceived 1 prior treatment
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger