Ischemic Heart DiseaseMobile4HeartNCT03446313
Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)
A study testing Movn Mobile App in people with Ischemic Heart Disease and Unstable Angina, run by University of California, San Francisco at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Unstable Angina, Systolic Heart Failure
- What is being tested?
- Movn Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2018to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Muir Medical Center
Concord, California, 94520
John Muir Medical Center
Walnut Creek, California, 94958
About this study
Official title: A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)
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.
- Being tested
- Movn Mobile App
- Medical subject headings
- Myocardial Ischemia, Angina, Unstable, Heart Failure, Systolic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movn Mobile AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MVN Group | Experimental | Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps Per Day
Physical activity will be measured by steps per day using activity tracker.
Measured: Two months
6MWT
Physical activity will be measured by a six minute walk test.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 2 months
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.
Measured: 2 months
Acceptability
Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start28 Feb 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Park, PhD, Principal investigator, UCSF, John Muir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446313
- Sponsor's protocol ID
- Mobile4Heart
- Other IDs
- 17-22717
- Acronym
- Mobile4Heart
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)
- ClinicalTrials.gov ID
- NCT03446313
- Acronym / sponsor ID
- Mobile4Heart / Mobile4Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVN Group | Experimental | Behavioral: Movn Mobile AppParticipants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movn Mobile AppThe 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. | Behavioural | MVN Group |
Primary outcome
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.
3 secondary outcomes
PHQ-9
Time frame: 2 months
Exercise Self-Efficacy Scale (EXSE)
Time frame: 2 months
Acceptability
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33861204Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Park, PhD principal investigator
UCSF, John Muir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movn Mobile App in people with Ischemic Heart Disease and Unstable Angina, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps Per Day (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.