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

NCT ID: NCT03446313

Last Updated: 2025-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-04-05

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.

Conditions

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Ischemic Heart Disease Unstable Angina Systolic Heart Failure Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MVN Group

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

Group Type EXPERIMENTAL

Movn Mobile App

Intervention Type BEHAVIORAL

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.

Usual Care

Participants assigned to the Usual Care group will receive standard instructions and educational handouts after they are discharged from cardiac rehab.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Park, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF, John Muir Medical Center

Locations

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John Muir Medical Center

Concord, California, United States

Site Status

John Muir Medical Center

Walnut Creek, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33861204 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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17-22717

Identifier Type: OTHER

Identifier Source: secondary_id

Mobile4Heart

Identifier Type: -

Identifier Source: org_study_id

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