Clinical trial NCT03446313: Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)
Official title: A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Unstable Angina
Systolic Heart Failure
Cardiovascular Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Steps Per Day
timeFrame: Two months
measure: 6MWT
timeFrame: 2 months
Secondary outcomes:
measure: PHQ-9
timeFrame: 2 months
measure: Exercise Self-Efficacy Scale (EXSE)
timeFrame: 2 months
measure: Acceptability
timeFrame: 2 months
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
Study officials:
affiliation: UCSF, John Muir Medical Center
name: Linda Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.