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Clinical Trials/NCT03446313
NCT03446313
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country60 target enrollmentFebruary 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
University of California, San Francisco
Enrollment
60
Locations
1
Primary Endpoint
Steps Per Day
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2018
End Date
April 5, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Steps Per Day

Time Frame: Two months

Physical activity will be measured by steps per day using activity tracker.

6MWT

Time Frame: 2 months

Physical activity will be measured by a six minute walk test.

Secondary Outcomes

  • PHQ-9(2 months)
  • Exercise Self-Efficacy Scale (EXSE)(2 months)
  • Acceptability(2 months)

Study Sites (1)

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