NCT03446313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
6 years until next milestone

Results Posted

Study results publicly available

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 14, 2018

Results QC Date

November 16, 2021

Last Update Submit

March 24, 2025

Conditions

Ischemic Heart DiseaseUnstable AnginaSystolic Heart FailureCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Steps Per Day

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

    Two months

  • 6MWT

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

    2 months

Secondary Outcomes (3)

  • PHQ-9

    2 months

  • Exercise Self-Efficacy Scale (EXSE)

    2 months

  • Acceptability

    2 months

Study Arms (2)

MVN Group

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Movn Mobile AppBEHAVIORAL

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.

MVN Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Muir Medical Center

Concord, California, 94520, United States

Location

John Muir Medical Center

Walnut Creek, California, 94958, United States

Location

Related Publications (1)

  • 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.

    PMID: 33861204DERIVED

MeSH Terms

Conditions

Myocardial IschemiaAngina, UnstableHeart Failure, SystolicCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeart Failure

Results Point of Contact

Title
Linda Park, Principle Investigator
Organization
University of California, San Francisco
linda.park@ucsf.edu
415-502-6616

Study Officials

  • Linda Park, PhD

    UCSF, John Muir Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 26, 2018

Study Start

February 28, 2018

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

April 10, 2025

Results First Posted

April 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)