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

Primary Purpose

Ischemic Heart Disease, Unstable Angina, Systolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movn Mobile App
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Muir Medical Center
  • John Muir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MVN Group

Usual Care

Arm Description

Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression
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.
Self-efficacy
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.
Satisfaction with the app
Satisfaction with the app will be measured by interviewing a subset of participants.

Full Information

First Posted
February 14, 2018
Last Updated
May 8, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03446313
Brief Title
Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)
Acronym
Mobile4Heart
Official Title
A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Unstable Angina, Systolic Heart Failure, Cardiovascular Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVN Group
Arm Type
Experimental
Arm Description
Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants assigned to the Usual Care group will receive standard instructions and educational handouts after they are discharged from cardiac rehab.
Intervention Type
Behavioral
Intervention Name(s)
Movn Mobile App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity
Description
Physical activity will be measured by an activity tracker.
Time Frame
Physical activity will be measured over the duration of two months.
Title
Physical activity
Description
Physical activity will be measured by a six minute walk test.
Time Frame
Physical activity will be measured over the duration of two months.
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
Depression will be measured at baseline and at month 2.
Title
Self-efficacy
Description
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.
Time Frame
Self-efficacy will be measured at baseline and at month 2.
Title
Satisfaction with the app
Description
Satisfaction with the app will be measured by interviewing a subset of participants.
Time Frame
Satisfaction will be measured at month 2 through individual interviews.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Park, PhD
Organizational Affiliation
UCSF, John Muir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
John Muir Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94958
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33861204
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.
Results Reference
derived

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

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