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CompletedNCT03446313Mobile4HeartUpdated Apr 10, 2025Results posted

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

An interventional study of Movn Mobile App in Ischemic Heart Disease, Unstable Angina and Systolic Heart Failure, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMovn 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.

05

What researchers measure

Primary outcomes

  1. Steps Per Day

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

    Time frame: Two months

  2. 6MWT

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

    Time frame: 2 months

Secondary outcomes

  1. PHQ-9

    Depression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 (lowest) to 27 (highest), higher score associated with moderate to severe depression.

    Time frame: 2 months

  2. Exercise Self-Efficacy Scale (EXSE)

    Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0 (lowest) to 100 (highest) with 0 indicating low self-efficacy and 100 indicating high self-efficacy.

    Time frame: 2 months

  3. Acceptability

    Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction

    Time frame: 2 months

06

Results

Posted Apr 10, 2025

Participant flow

Participant flow — Overall Study
MilestoneMVN GroupUsual Care
Started3228
Completed2625
Not completed63
Withdrew: Lost to follow-up12
Withdrew: Failed primary screening30
Withdrew: Diagnosed with terminal cancer10
Withdrew: Excluded from analysis11

Outcome measures

PrimarySteps Per Day

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

Time frame:
Two months
Reported as:
Mean · Steps/day
Steps Per Day
Steps/dayMVN GroupUsual Care
Steps Per Day8860 ± 53346633 ± 4684
Primary6MWT

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

Time frame:
2 months
Reported as:
Mean · meters
6MWT
metersMVN GroupUsual Care
6MWT430 ± 112429 ± 97
SecondaryPHQ-9

Depression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 (lowest) to 27 (highest), higher score associated with moderate to severe depression.

Time frame:
2 months
Reported as:
Mean · score on a scale
PHQ-9
score on a scaleMOVNUsual Care
PHQ-91 (0 to 3)2 (0 to 3)
SecondaryExercise Self-Efficacy Scale (EXSE)

Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0 (lowest) to 100 (highest) with 0 indicating low self-efficacy and 100 indicating high self-efficacy.

Time frame:
2 months
Reported as:
Mean · score on a scale
Exercise Self-Efficacy Scale (EXSE)
score on a scaleMVN GroupUsual Care
Exercise Self-Efficacy Scale (EXSE)10 (9.9 to 10)9.9 (8.4 to 10)
SecondaryAcceptability

Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction

Time frame:
2 months
Reported as:
Mean · Score on a scale
Acceptability
Score on a scaleMVN GroupUsual Care
Fitbit device4.83 ± 0.41—
Movn app4.5 ± 0.71—

Adverse events

Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MVN Group0/32 (0%)1/32 (3.1%)0/32 (0%)
Usual Care0/28 (0%)0/28 (0%)0/28 (0%)
Most frequent serious events
Most frequent serious events
EventMVN GroupUsual Care
Terminal cancer diagnosis unrelated to studyNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/320/28

Baseline characteristics

We enrolled 60 individuals; however, 9 withdrew or were lost to follow-up (6 from the intervention group and 3 from the control group), representing 15% (9/60) attrition.

Age, Categorical
Age, Categorical(Participants)MVN GroupUsual CareTotal
<=18 years000
Between 18 and 65 years111122
>=65 years151429
Age, Continuous
Age, Continuous(years)MVN GroupUsual CareTotal
Mean66.7 ± 8.666.8 ± 8.766.8 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)MVN GroupUsual CareTotal
Female6511
Male202040
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MVN GroupUsual CareTotal
Hispanic or Latino123
Not Hispanic or Latino252348
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MVN GroupUsual CareTotal
American Indian or Alaska Native000
Asian314
Native Hawaiian or Other Pacific Islander000
Black or African American101
White192241
More than one race112
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)MVN GroupUsual CareTotal
United States262551
07

Study locations

2 sites
  • John Muir Medical Center
    Concord, California 94520, United States
  • John Muir Medical Center
    Walnut Creek, California 94958, United States
08

References and documents

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. PubMed 33861204 ↗

Study documents

  • Study protocol · Feb 23, 2018
  • Statistical analysis plan · Apr 23, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03446313
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Feb 28, 2018
Primary completion
Apr 5, 2019
Completion
Apr 5, 2019
Results posted
Apr 10, 2025
Last update
Apr 10, 2025

Study contacts

Linda Park, PhD
principal investigator · UCSF, John Muir Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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