The Morehouse-Emory Cardiovascular Center for Health Equity Study: Clinical Intervention Project
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): Health360x; Health Coach
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will view an orientation video which will include information on how to access the program from home and other internet access sites, how to use their activity monitor and sphygmomanometers, introduction to the curriculum, quizzes and discussion boards. Participants will be encouraged to upload their data at least once a week and to access the curriculum as often as desired. Technological and customer service support related to use of the application will be available 24 hours by phone.; Participants will be contacted by the health coach in the first week of the study to review their initial self-management behavioral goals and approaches. Follow up calls will occur each week for the first month, biweekly for the second and third months, and then once per month for the remainder of the study (months 4-6).
Other intervention name(s): eHealthystrides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular health; Health coach; Cardiovascular risk factors; Ethnic disparities; Behavioral intervention; E-health lifestyle intervention; Health360x; eHealthyStrides