MECA Clinical Intervention ( MECA Health360x)

NCT ID: NCT04791618

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2021-12-31

Brief Summary

The purpose of this research is to test whether a technology application(Health360x) that lets participants set goals for better health and track health can help participants reduce their heart disease risk. Investigators will compare life style intervention using Health360x alone with Health360xs plus health coach on AHA(American Heart Association) LS7 scores after 6 months.

Detailed Description

Study volunteers' participation in this study will last for 6 months. Investigators will ask participants to examine their own health behaviors. The purpose of the examination is to find the areas that need improvement so participants can work on them. Investigators will use technology in the form of Health360x to support participant efforts to change health behaviors.

This list below, shows the activities you will perform as part of this research.

Arm A ='High tech' Arm B='High tech high touch"

1. Recruitment Phone call: During this call, investigators will do the following:

• Collect email address
• Phone# that can receive text messages
• Contact information for 2 close friends/relatives

2. Investigators will email participants enrollment and welcome package that contains links to the

• Online screening form
• Consent form Please complete both forms

3. Investigators will send participants a link to online training videos and Health360x user manual that show how to use health360x and the online user manual

• Participants will show investigative team that they know how to use Health360x by completing a proficiency test

4. Investigators will have Live chat sessions to answer questions about the project by the health coach and PI. Participants can access these as needed

5. Participants will be assigned by chance, to High tech only(Arm A) or high tech and high touch(Arm B). Participant will receive an email notification of what study arm they are enrolled in

6. Self- assessment; LS7 score

7. Participant will receive a sleep/activity tracker; Investigators will work to obtain a Blood Pressure monitor through participants' usual health insurance

8. Weekly goal setting; personal action plan x4 weeks Arm A participants will receive email prompts to complete. Arm B participants will complete; 45minute-1 hour meetings with health coach (recorded)

9. Every 2-week goal setting; personal action plans x4 Arm A participants will receive email prompts to complete; Arm B participants will complete 45 minute-1 hour long meetings with health coach(recorded)

10. Every 1 monthly goal setting; personal action plan x3 Arm A participants will receive email prompts to complete; Arm B participants will complete 45 minute-1 hour long meetings with health coach(recorded)

Conditions

Cardiovascular Health; Self-management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health360x only (High tech)

Access to Health360x technology only for 6 months Behavioral: Health360x Participants will receive Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self- management skills. Every participant will view an orientation video which will include information on how to access Health360 from home and other internet connected devices; how to use activity monitors provided by the study and sphygmomanometer. They will receive an introduction to heart health curriculum, quizzes and discussion forums. 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 Helath360x application will be available online and by phone.

The Health360x application will send messages to participants in this arm reminding them to perform study related activities.

Group Type: ACTIVE_COMPARATOR

Health360x only (High tech)

Intervention Type: BEHAVIORAL

All participants will have access to Helath360x with reminders generated for goal setting.

Health360x plus Coach (High tech High touch)

Health360x technology plus health coach Behavioral: Health360x plus health coach Participants will receive all of the resources in Arm A and Health coach interactions.

The Health coach will send messages to participants in this arm reminding them to perform study related activities. The coach interactions will be focused on helping with attainment of self- management behaviors

Group Type: EXPERIMENTAL

Health360x plus health coach

Intervention Type: BEHAVIORAL

Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills

Health360x only (High tech)

Intervention Type: BEHAVIORAL

All participants will have access to Helath360x with reminders generated for goal setting.

Interventions

Health360x plus health coach

Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills

Intervention Type: BEHAVIORAL

Health360x only (High tech)

All participants will have access to Helath360x with reminders generated for goal setting.

Intervention Type: BEHAVIORAL

Other Intervention Names

Health coach intervention; Self management skills training; Goal setting; Monitoring; Healthy coping; e-Health lifestyle intervention; Self management skills training; Goal setting; Monitoring; Healthy coping

Eligibility Criteria

Inclusion Criteria

• Already participating in baseline clinical study
• Volunteers with AHA LS7 scores of 4 or lower who have access to internet (community or personal),self-reported ability to participate in physical activity, and English fluency.

Exclusion Criteria

• CAD documented by CAD diagnosis or prior acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or chronic angina; aortic stenosis; inability to participate in increased physical activity; history of alcohol or drug abuse or psychiatric diagnosis that would interfere with ability to participate.

Pregnant and/or breastfeeding women will be excluded. Cognitive deficits severe enough to preclude participation or any medical or surgical problem that precludes meaningful participation; unwillingness to use the internet

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Priscilla Pemu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herman Taylor, MD

Role: STUDY_CHAIR

Morehouse School of Medicine

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Emory University Clinical Research Network

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

809392

Identifier Type: -

Identifier Source: org_study_id