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| ID | Type | Description | Link |
|---|---|---|---|
| 17-22717 | Other Identifier | University of California, San Francisco |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVN Group | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Movn Mobile App | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Steps Per Day | Physical activity will be measured by steps per day using activity tracker. | Two months |
| 6MWT | Physical activity will be measured by a six minute walk test. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Exercise Self-Efficacy Scale (EXSE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Park, PhD | UCSF, John Muir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Medical Center | Concord | California | 94520 | United States | ||
| John Muir Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33861204 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steps Per Day | Physical activity will be measured by steps per day using activity tracker. | Posted | Mean | Standard Deviation | Steps/day | Two months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MVN Group | Participants assigned to the MVN Group will be using the Movn Rehab mobile app after they are discharged from cardiac rehab. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Terminal cancer diagnosis unrelated to study | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Park, Principle Investigator | University of California, San Francisco | 415-502-6616 | linda.park@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2018 | Jun 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2019 | Aug 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D000789 | Angina, Unstable |
| D054143 | Heart Failure, Systolic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
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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.
| 2 months |
| Acceptability | Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction | 2 months |
| Walnut Creek |
| California |
| 94958 |
| United States |
| Diagnosed with terminal cancer |
|
| Excluded from analysis |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Primary | 6MWT | Physical activity will be measured by a six minute walk test. | Posted | Mean | Standard Error | meters | 2 months |
|
|
|
| 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. | Posted | Mean | Inter-Quartile Range | score on a scale | 2 months |
|
|
|
| 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. | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | 2 months |
|
|
|
| Secondary | Acceptability | Satification survey, scored 0 (lowest) to 5 (highest), higher score associated with greater satisfaction | Surveys were given to participants in the intervention group who agreed to participate in individual interviews. | Posted | Mean | Standard Deviation | Score on a scale | 2 months |
|
|
|
| 0 |
| 32 |
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Usual Care | Participants assigned to the Usual Care group will receive standard instructions and educational handouts after they are discharged from cardiac rehab. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |