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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Technology-based Intervention for Improving Self-management Behaviors in Black Adults With Poor Cardiovascular Health: MECA Clinical Intervention Project

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Health360x
* Behavioral: Health Coach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health360x<br>Participants will use the Health360x application for 6 months. | Behavioral: Health360x<br>* 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.<br>* Other names: eHealthystrides;|
| Experimental: Health360x plus health coach<br>Participants will use the Health360x application and received personalized health coaching for 6 months. | Behavioral: Health360x<br>* 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.<br>* Other names: eHealthystrides;Behavioral: Health Coach<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Life Simple 7 (LS7) composite score | The Life Simple 7 (LS7) Cardiovascular Health Index is a public health metric by the American Heart Association (AHA) and is an index of modifiable health behaviors and cardiometabolic risk factors. The LS7 includes three health factors (blood pressure, fasting glucose, total cholesterol) and four health behaviors (body mass index (BMI), physical activity, healthy diet and smoking) and classifies each of them as ideal (score of 2), intermediate (score of 1) and poor (score of 0) levels. Total scores range from 0 to 14 and total scores between 0-4 are classified as inadequate, scores between 5-9 are considered average, and scores between 10-14 are classified as optimum cardiovascular health. | Baseline, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Blood pressure readings will be made three times with the subject at rest in the sitting position using a cuff of the appropriate size and a standardized procedure. The average of the three systolic blood pressure measurements will be calculated. Blood pressure will be categorized according to Joint National Committee recommendations. | Baseline, Month 6 | 
| Change in Diastolic Blood Pressure | Blood pressure readings will be made three times with the subject at rest in the sitting position using a cuff of the appropriate size and a standardized procedure. The average of the three diastolic blood pressure measurements will be calculated. Blood pressure will be categorized according to Joint National Committee recommendations. | Baseline, Month 6 | 
| Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ) | Dietary intake of fruits and vegetables will be assessed using the Lower Mississippi Delta Nutrition Intervention Research Initiative food frequency questionnaire (Delta NIRI FFQ). The Delta NIRI FFQ is a 283-item, interviewer administered questionnaire that asks if respondents have had certain food items in the past 24 hours, including foods that are commonly consumed in the southern United States. | Baseline, Month 6 | 
| Change in Blood Glucose | Blood glucose will be measured as milligrams per deciliter at Baseline, 3 months after the start of the intervention and at the end of the intervention at month 6. Normal, fasting blood glucose levels are between 70 to 100 mg/dL. | Baseline, Month 3, Month 6 | 
| Change in Distance Walked Daily | The total distance walked daily in miles will be measured by a pedometer or the exercise application for mobile devices. | Baseline, Month 3, Month 6 | 
| Change in Short Form-12 Health Survey Questionnaire (SF-12) score | The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. The total score for each subscale ranges from 0 to 100 and low values represent a poor health state while high values represent a good health state. | Baseline, Month 3, Month 6 | 
| Change in Stress Management | Participants will report on their stress management monthly via free text responses in an online format. | Baseline, then monthly through Month 6 | 
| Change in Weight | Participants will report their weight in pounds once per month during the intervention period. | Baseline, then monthly through Month 6 | 
| Change in Tobacco Use | Participants will report whether or not they have used tobacco once per month during the intervention period. | Baseline, then monthly through Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular health, Health coach, Cardiovascular risk factors, Ethnic disparities, Behavioral intervention, E-health lifestyle intervention, Health360x, eHealthyStrides