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The Morehouse-Emory Cardiovascular Center for Health Equity Study: Clinical Intervention Project (MECA)

Emory University logo

Emory University

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Behavioral: Health360x
Behavioral: Health Coach

Study type

Interventional

Funder types

Other

Identifiers

NCT03308812
IRB00083584

Details and patient eligibility

About

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.

Full description

The internet can be an effective tool for driving behavior change but minority populations are less likely to engage or use this tool effectively. Health information technology (also called ehealth or e-health) can provide continuous and systematic connections to patients that will support their personal roles and responsibilities in their health care management. Ehealth technology allows for the tailoring of tools to the individual, timely information delivery, standardized messaging, layered content for more motivated participants, and the potential for greater efficiency/cost savings. Ehealth is able to provide effective and sustainable self-management tools for patients with chronic diseases. There is a significant trend towards information seeking on the internet among populations that have lower health literacy and are less trusting of the health system but, although minority and health disparities populations have increasing access to wireless and mobile technology, this has not translated to increased use of ehealth technologies.

The ehealth application used in this study aims to use the internet to engage vulnerable populations in improving their cardiovascular health. The intervention uses an enriched information environment, dynamic, personalized feedback on relevant health parameters, and social networks to impact health literacy, optimism and other resilience factors. This study will test two approaches to engagement with a robust ehealth application (Health360x) for high risk minority patients who reside in resilient and at risk neighborhoods within metro Atlanta. The Health360x application is a system that frames behavior as changeable and adaptable in a bidirectional manner, based on the behavioral constructs of Capability, Opportunity, and Motivation. Capability is the psychological and physical capacity to engage in the activity concerned, including the necessary knowledge and skills. Opportunity refers to factors that lie outside the individual, that facilitate or prompt the behavior. Motivation is largely governed by the brain processes that energize and direct behavior, including goal directed conscious decision-making, habitual processes, emotional response, as well as analytical decision-making.

This study is part of a larger project that is a partnership between investigators at Emory University and Morehouse School of Medicine who are actively involved in investigating ethnic disparities and incorporating the role of resilience factors in improving health status among black persons in metro Atlanta. The aim of this multi-disciplinary team is to establish a unique cohort in order to examine the associations between personal factors (psychosocial factors, socio-economic class, healthy behaviors and health beliefs) and environmental influences (neighborhood) on health behaviors and physiologic measures.

Four hundred subjects from "at risk" and "resilient" census tracks in metro Atlanta who completed the population surveys will be invited to participate in the Baseline Clinical Study, which is part of the Morehouse-Emory Cardiovascular (MECA) Center for Health Equity Study. The clinical trial described here will recruit 150 participants from the 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.

Enrollment

150 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Health360x
Active Comparator group
Description:
Participants will use the Health360x application for 6 months.
Treatment:
Behavioral: Health360x
Health360x plus health coach
Experimental group
Description:
Participants will use the Health360x application and received personalized health coaching for 6 months.
Treatment:
Behavioral: Health Coach
Behavioral: Health360x

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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