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Trial record 1 of 4 for:    Movn | cardiac rehab | United States
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Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart) (Mobile4Heart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03446313
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Park, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Unstable Angina Systolic Heart Failure Cardiovascular Diseases Behavioral: Movn Mobile App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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
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.

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.



Primary Outcome Measures :
  1. Physical activity [ Time Frame: Physical activity will be measured over the duration of two months. ]
    Physical activity will be measured by an activity tracker.

  2. Physical activity [ Time Frame: Physical activity will be measured over the duration of two months. ]
    Physical activity will be measured by a six minute walk test.


Secondary Outcome Measures :
  1. Depression [ Time Frame: Depression will be measured at baseline and at month 2. ]
    Depression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores can range from 5 to greater than 20 with 5 indicating minimal symptoms and 20 indicating severe major depression.

  2. Self-efficacy [ Time Frame: Self-efficacy will be measured at baseline and at month 2. ]
    Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0-100 with 0 indicating no self-efficacy and 100 indicating high self-efficacy.

  3. Satisfaction with the app [ Time Frame: Satisfaction will be measured at month 2 through individual interviews. ]
    Satisfaction with the app will be measured by interviewing a subset of participants.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446313


Locations
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United States, California
John Muir Medical Center
Concord, California, United States, 94520
John Muir Medical Center
Walnut Creek, California, United States, 94958
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Linda Park, PhD UCSF, John Muir Medical Center

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Responsible Party: Linda Park, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03446313     History of Changes
Other Study ID Numbers: Mobile4Heart
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Coronary Artery Disease
Heart Failure, Systolic
Coronary Disease
Cardiovascular Diseases
Myocardial Ischemia
Angina, Unstable
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms