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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Ischemic Heart Disease; Unstable Angina; Systolic Heart Failure
• Intervention / Treatment: Behavioral: Movn Mobile App

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center
    • Walnut Creek, California, United States, 94958
      • John Muir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MVN Group; 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; 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.
NO_INTERVENTION: Usual Care; 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?

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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Linda Park, PhD, UCSF, John Muir Medical Center

Publications and helpful links

General Publications

• Park LG, Elnaggar A, Lee SJ, Merek S, Hoffmann TJ, Von Oppenfeld J, Ignacio N, Whooley MA. Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Apr 16;5(4):e20468. doi: 10.2196/20468.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): April 5, 2019
• Study Completion (ACTUAL): April 5, 2019

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Angina, Unstable; Heart Failure, Systolic
• Other Study ID Numbers: Mobile4Heart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No