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Cardiovascular DiseasesMECANCT03308812

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

A study testing Health360x and Health Coach in people with Cardiovascular Diseases, run by Emory University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Health360x and Health Coach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
3 sitesUnited States
Study dates
25 Jul 2017to 30 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

United States3 sites
  • Grady Health System

    Atlanta, Georgia, 30303

  • Morehouse School of Medicine, Clinical Research Center

    Atlanta, Georgia, 30310

  • Emory University Clinical Research Network

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Health360x, Health Coach
Keywords
Cardiovascular health, Health coach, Cardiovascular risk factors, Ethnic disparities, Behavioral intervention, E-health lifestyle intervention, Health360x, eHealthyStrides
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health360xBehavioural

    Also called eHealthystrides

    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.

  • Health CoachBehavioural

    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).

Study groups in NCT03308812
Study groupRoleWhat they receive
Health360xActive comparatorParticipants will use the Health360x application for 6 months.
Receives: Behavioral: Health360x
Health360x plus health coachExperimentalParticipants will use the Health360x application and received personalized health coaching for 6 months.
Receives: Behavioral: Health360x; Behavioral: Health Coach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Month 6

Secondary outcomes (9)
  1. 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.

    Measured: Baseline, Month 6

  2. 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.

    Measured: Baseline, Month 6

  3. 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.

    Measured: Baseline, Month 6

  4. 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.

    Measured: Baseline, Month 3, Month 6

  5. 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.

    Measured: Baseline, Month 3, Month 6

  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.

    Measured: Baseline, Month 3, Month 6

  7. Change in Stress Management

    Participants will report on their stress management monthly via free text responses in an online format.

    Measured: Baseline, then monthly through Month 6

  8. Change in Weight

    Participants will report their weight in pounds once per month during the intervention period.

    Measured: Baseline, then monthly through Month 6

  9. Change in Tobacco Use

    Participants will report whether or not they have used tobacco once per month during the intervention period.

    Measured: Baseline, then monthly through Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study start25 Jul 2017
  3. Primary completion30 Jan 2020
  4. Study completion30 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308812
Sponsor's protocol ID
IRB00083584
Acronym
MECA
Status last verified
Mar 2020
First submitted
9 Oct 2017
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32340530

Questions about this trial

What is this clinical trial studying?

A study testing Health360x and Health Coach in people with Cardiovascular Diseases, run by Emory University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Life Simple 7 (LS7) composite score (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03308812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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