Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether using a mobile app increases adherence to a heart healthy prescription after discharge from a cardiac rehab program.

Detailed Description
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Ongoing maintenance of physical activity after cardiac rehab is an important part of preventing secondary cardiac events in patients with ischemic heart disease. Our central hypothesis is that monitoring and promotion of health-related behaviors by increasing patient-provider communication through a mobile device after discharge from cardiac rehab increased adherence to a heart healthy prescription over time. Participants will be randomly assigned to use a mobile app or serve as the control group. All participants will have an activity tracker to track their activity for two months.

Official Title
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A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)

Conditions
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Ischemic Heart Disease, Unstable Angina, Systolic Heart Failure, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Movn Mobile App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age History of cardiovascular disease that qualified patient for cardiac rehab (i.e. ischemic heart disease, history of unstable angina, systolic heart failure with ejection fraction at 35% or less, and Class II to IV symptoms, coronary artery bypass graft surgery, valve replacement) Own a smartphone or tablet Exclusion Criteria: Cognitive impairment Lack of English proficiency/literacy Clinical conditions including: unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, symptomatic anemia, active infection, uncontrolled hypertension (resting diastolic > 100 mmHg, systolic > 180 mmHg), decompensated heart failure NYHA class 3-4, current unstable angina, 2nd or 3rd degree heart block, or uncontrolled high grade exercise-induced ventricular ectopy

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MVN Group<br>Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab. | Behavioral: Movn Mobile App<br>* The Movn app will have each participant's personalized instructions for post-cardiac rehab integrated into it including medication reminders, physical activity prompts, educational materials, and patient-reported outcomes.<br>|
| No Intervention: Usual Care<br>Participants assigned to the Usual Care group will receive standard instructions and educational handouts after they are discharged from cardiac rehab. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activity will be measured by an activity tracker. | Physical activity will be measured over the duration of two months. | 
| Physical activity | Physical activity will be measured by a six minute walk test. | Physical activity will be measured over the duration of two months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores can range from 5 to greater than 20 with 5 indicating minimal symptoms and 20 indicating severe major depression. | Depression will be measured at baseline and at month 2. | 
| Self-efficacy | Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0-100 with 0 indicating no self-efficacy and 100 indicating high self-efficacy. | Self-efficacy will be measured at baseline and at month 2. | 
| Satisfaction with the app | Satisfaction with the app will be measured by interviewing a subset of participants. | Satisfaction will be measured at month 2 through individual interviews. |