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Behavioural Intervention
Mobile Health Rehabilitation for Heart Disease (RESILIENT Trial)
N/A
Waitlist Available
Led By John Dodson, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥65
Capable of self-consent
Must not have
Moderate or severe cognitive impairment
Severe osteoarthritis, or joint replacement within last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a mobile health program can help improve heart function in older adults compared to traditional care. A total of 400 patients will be enrolled and followed for at least 3 months.
Who is the study for?
This trial is for older adults aged 65 or above who have been hospitalized for ischemic heart disease (like a heart attack, stent placement, or bypass surgery) recently. They must be able to walk, give consent themselves, and use mobile health technology in English or Spanish. People with severe movement disorders, very short life expectancy, severe cognitive issues, certain recent surgeries or conditions that limit walking are not eligible.
What is being tested?
The RESILIENT study tests if a mobile health cardiac rehab program (mHealth-CR) can improve the physical function of older adults after hospitalization due to heart disease better than standard care. Participants will either receive mHealth-CR or usual care in a ratio of 3:1 by random selection.
What are the potential side effects?
Since this trial involves non-drug interventions like using mobile health technology for rehabilitation exercises at home rather than medication side effects may include discomfort from exercise and potential injury if exercises are performed improperly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
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I am able to understand and agree to the study on my own.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant memory or thinking problems.
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I have severe joint pain or had a joint replacement recently.
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I regularly use a walker to move around.
Select...
I cannot use mobile health apps in English or Spanish.
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I have a groin injury from a heart procedure that stops me from walking quickly.
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I have Parkinson's disease or a similar movement disorder.
Select...
I cannot walk by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average weekly percent completion of the mHealth-CR program
Change in 6-minute walking distance (6MWD)
Secondary study objectives
Change in 12-Item Short Form Survey (SF-12) score
Change in Activities of Daily Living (ADLs)
Change in Basic Activities of Daily Living (BADLs)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mHealth-CRExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,185 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
15,910 Patients Enrolled for Coronary Artery Disease
National Institutes of Health (NIH)NIH
2,815 Previous Clinical Trials
8,161,247 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
11,491 Patients Enrolled for Coronary Artery Disease
John Dodson, MDPrincipal InvestigatorNew York Langone Health
3 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a left ventricular assist device.I can follow study instructions and perform tasks like a 6-minute walk test.The doctors think there are other safety concerns or you might not follow the study rules.I have significant memory or thinking problems.I have severe joint pain or had a joint replacement recently.I regularly use a walker to move around.I completed a heart rehab program in the last 3 months.I cannot use mobile health apps in English or Spanish.I have a groin injury from a heart procedure that stops me from walking quickly.Doctors think you may live for less than 3 months.You are currently on the waiting list for a heart transplant.You are in prison.I have Parkinson's disease or a similar movement disorder.I am 65 years old or older.I am currently in the hospital or was hospitalized in the last 2 weeks for a heart attack or heart surgery.I am able to understand and agree to the study on my own.I cannot walk by myself.
Research Study Groups:
This trial has the following groups:- Group 1: mHealth-CR
- Group 2: Usual 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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