The Morehouse-Emory Cardiovascular Center for Health Equity Study: Clinical Intervention Project (NCT03308812) | Clinical Trial Compass
CompletedNot Applicable
The Morehouse-Emory Cardiovascular Center for Health Equity Study: Clinical Intervention Project
United States150 participantsStarted 2017-07-25
Plain-language summary
This study will recruit from participants in the Morehouse-Emory Cardiovascular (MECA) study for a clinical intervention examining cardiac outcomes between participants who are randomized to received Health360x (a web-based and mobile-based application) or Health360x plus personalized health coaching. Participants will receive instruction on using the Health360x application and will use Health360x alone or Health360x with a health coach for 6 months. Measures of cardiovascular health will be assessed at baseline and after the 6 month long intervention.
Who can participate
Age range
21 Years – 70 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:
* Already participating in the Baseline Clinical Study
* Life Simple 7 (LS7) score of 8 or lower
* Internet access
* Self-reported ability to participate in physical activity
* English fluency
Exclusion Criteria:
* Coronary Artery Disease (CAD) documented by CAD diagnosis or prior acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or chronic angina
* Aortic stenosis
* History of chronic diseases that may alter brachial artery flow-mediated vasodilation measurements, such as peripheral vascular disease, HIV/AIDS, lupus, or cancer
* Inability to participate in increased physical activity
* History of alcohol or drug abuse or psychiatric diagnosis that would interfere with ability to participate
* Women who are pregnant and/or breastfeeding
* Cognitive deficits severe enough to preclude participation or any medical or surgical problem that precludes meaningful participation
* Unwillingness to use the internet
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.