Cardiovascular Diseases, Ischemic Heart Disease, Systolic Heart Failure, Unstable Angina
Conditions
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.
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps Per Day | Two months | Physical activity will be measured by steps per day using activity tracker. |
| 6MWT | 2 months | Physical activity will be measured by a six minute walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 | 2 months | 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. |
| Exercise Self-Efficacy Scale (EXSE) | 2 months | 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. |
| Acceptability | 2 months | Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MVN Group The intervention group received (1) a Charge 2 (Fitbit Inc) to record step counts, (2) a Movn mobile app to record exercise, and (3) push-through motivational PA prompts and educational messages related to CVD management. Messages were sent from the study team through the Movn app as a push notification 3 times per week on random days between 9 AM and 6 PM to provide positive feedback and additional motivation for PA. These 1- and 2-way messages were based on the American Heart Association Simple 7 principles \[24\] and prompted participants to engage in PA, keep healthy eating habits, or track their medication use.
Additionally, participants could use the Movn app to record daily weight, blood pressure, heart rate, medication use, and other exercise (eg, swimming, biking) not captured by the Fitbit device. Every time they chose to record any of these other measures, they were prompted to complete this information through a push notification from the app. Finally, mHealth participants had the ability to report any cardiovascular symptoms through the Movn app. If the participant reported shortness of breath or chest pain, a message prompted them with a button to call 911. The study team triaged participant entries once a day. | 26 |
| Usual Care Participants in the control group were provided a basic pedometer (Walking 3D, IceFox) and paper-and-pencil diary to record daily step counts. They were asked to fasten the pedometer around their waist or to place it in their pants pocket during all waking hours.
All participants received a phone call (or text message if in the intervention group) 3 days following enrollment to answer any questions regarding the study and verify adherence to the assigned regimen. After 1 month of participation, participants received a follow-up phone call or text sent by the study staff. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnosed with terminal cancer | 1 | 0 |
| Overall Study | Excluded from analysis | 1 | 1 |
| Overall Study | Failed primary screening | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | MVN Group | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 66.7 years STANDARD_DEVIATION 8.6 | 66.8 years STANDARD_DEVIATION 8.7 | 66.8 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 23 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 19 Participants | 22 Participants | 41 Participants |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 28 |
| other Total, other adverse events | 0 / 32 | 0 / 28 |
| serious Total, serious adverse events | 1 / 32 | 0 / 28 |
Outcome results
Primary
6MWT
Physical activity will be measured by a six minute walk test.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVN Group | 6MWT | 430 meters | Standard Error 112 |
| Usual Care | 6MWT | 429 meters | Standard Error 97 |
Primary
Steps Per Day
Physical activity will be measured by steps per day using activity tracker.
Time frame: Two months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVN Group | Steps Per Day | 8860 Steps/day | Standard Deviation 5334 |
| Usual Care | Steps Per Day | 6633 Steps/day | Standard Deviation 4684 |
Secondary
Acceptability
Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction
Time frame: 2 months
Population: Surveys were given to participants in the intervention group who agreed to participate in individual interviews.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVN Group | Acceptability | Fitbit device | 4.83 Score on a scale | Standard Deviation 0.41 |
| MVN Group | Acceptability | Movn app | 4.5 Score on a scale | Standard Deviation 0.71 |
Secondary
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
Population: Total scores for depressive symptoms and exercise self-efficacy were examined from baseline to 2 months. We also examined these variables as possible covariates related to the PA and 6MWT results.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MVN Group | Exercise Self-Efficacy Scale (EXSE) | 10 score on a scale |
| Usual Care | Exercise Self-Efficacy Scale (EXSE) | 9.9 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MVN Group | PHQ-9 | 1 score on a scale |
| Usual Care | PHQ-9 | 2 score on a scale |