Clinical trial NCT03308812: The Morehouse-Emory Cardiovascular Center for Health Equity Study: Clinical Intervention Project
Official title: Impact of Technology-based Intervention for Improving Self-management Behaviors in Black Adults With Poor Cardiovascular Health: MECA Clinical Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular health
Health coach
Cardiovascular risk factors
Ethnic disparities
Behavioral intervention
E-health lifestyle intervention
Health360x
eHealthyStrides
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-10-13
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Life Simple 7 (LS7) composite score
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, Month 6
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline, Month 6
measure: Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)
timeFrame: Baseline, Month 6
measure: Change in Blood Glucose
timeFrame: Baseline, Month 3, Month 6
measure: Change in Distance Walked Daily
timeFrame: Baseline, Month 3, Month 6
measure: Change in Short Form-12 Health Survey Questionnaire (SF-12) score
timeFrame: Baseline, Month 3, Month 6
measure: Change in Stress Management
timeFrame: Baseline, then monthly through Month 6
measure: Change in Weight
timeFrame: Baseline, then monthly through Month 6
measure: Change in Tobacco Use
timeFrame: Baseline, then monthly through Month 6
Other outcomes:
measure: Change in High-sensitivity C-reactive Protein (HsCRP)
timeFrame: Baseline, Month 6
measure: Change in Plasma Cysteine
timeFrame: Baseline, Month 6
measure: Change in Cystine
timeFrame: Baseline, Month 6
measure: Change in CD34+ Cell Count
timeFrame: Baseline, Month 6
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Baseline, Month 6
measure: Change in Reactive Hyperemia Index (RHI)
timeFrame: Baseline, Month 6
measure: Change in Glutathione
timeFrame: Baseline, Month 6
measure: Change in circulating progenitor cells (CPC) CD34+/CD133+
timeFrame: Baseline, Month 6
measure: Change in circulating progenitor cells (CPCs) CD34+/VEGF2R+
timeFrame: Baseline, Month 6
measure: Change in Augmentation Index
timeFrame: Baseline, Month 6
measure: Change in Carotid Intima Media Thickness (CIMT)
timeFrame: Baseline, Month 6
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine, Clinical Research Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Clinical Research Network
state: Georgia
Study officials:
affiliation: Emory University
name: Arshed Quyyumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Islam SJ, Kim JH, Topel M, Liu C, Ko YA, Mujahid MS, Sims M, Mubasher M, Ejaz K, Morgan-Billingslea J, Jones K, Waller EK, Jones D, Uppal K, Dunbar SB, Pemu P, Vaccarino V, Searles CD, Baltrus P, Lewis TT, Quyyumi AA, Taylor H. Cardiovascular Risk and Resilience Among Black Adults: Rationale and Design of the MECA Study. J Am Heart Assoc. 2020 May 5;9(9):e015247. doi: 10.1161/JAHA.119.015247. Epub 2020 Apr 28.