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

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Unstable Angina; Cardiovascular Diseases; Systolic Heart Failure
• Interventions: Behavioral: Movn Mobile App

• Registration Number: NCT03446313
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Study Start: 2018-02-28
• Primary Completion: 2019-04-05
• Study Completion: 2019-04-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVN Group	Movn Mobile App	Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab.

Primary Outcome Measures

Name	Time	Method
Physical activity	Physical activity will be measured over the duration of two months.	Physical activity will be measured by a six minute walk test.

Secondary Outcome Measures

Name	Time	Method
Depression	Depression will be measured at baseline and at month 2.	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.
Self-efficacy	Self-efficacy will be measured at baseline and at month 2.	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.
Satisfaction with the app	Satisfaction will be measured at month 2 through individual interviews.	Satisfaction with the app will be measured by interviewing a subset of participants.

Trial Locations

Locations (1)

John Muir Medical Center; 🇺🇸 Walnut Creek, California, United States