Cardiac Disease Clinical Trial
Official title:
Empowering Individuals Post-Cardiopulmonary Outpatient Rehabilitation to Continue to Live a Heart Healthy Lifestyle: Utilizing Mobile Health Technology
| NCT number | NCT02671669 |
| Other study ID # | 14-01809 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | March 1, 2018 |
| Verified date | May 2020 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized controlled trial of the feasibility and utility of implementing a smartphone application (MVN) to maintain compliance with a Heart Healthy lifestyle after discharge from a cardiac outpatient rehabilitation program. Patients will be randomized into one of two groups: usual care (control: UC) or Movn mobile application (intervention: MVN). This study will improve and strengthen data collection from this at-risk patient population by recording baseline clinical and psycho social measures while gaining insight into self-reporting of physical activity and frequency between the UC and MVN groups.
| Status | Completed |
| Enrollment | 67 |
| Est. completion date | March 1, 2018 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Current participants in The Joan and Joel Smilow Cardiac Rehabilitation and Prevention Center (JJCRPC) of Rusk Rehabilitation Patient within two weeks of completing outpatient cardiac rehabilitation - Clinically stable: moderate to low risk strata by standardized clinical assessment - Clinically stable: moderate to low risk strata by standardized clinical assessment - no infections - no unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia - controlled blood pressure-resting diastolic <100 mmHg, systolic <180mmHg - no uncompensated heart failure NYHA Class 3-4 - stable angina (no chest pain for month) - no 2nd or 3rd degree heart block - no uncontrolled high grade exercise induced ventricular ectopy-hemodynamically stable - Own an iPhone (version 3 or above), an iPad, or an iPod touch (version 4 or higher) or Android phone or tablet - Ability to use and comfortable with using mobile health technology to monitor physical and psychosocial health - Is comfortable using mobile applications - English language fluency - Ability to provide informed consent Exclusion Criteria: - Patients who do not fulfill all inclusion criteria stated above. |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York University School of Medicine | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in rate of exercise compliance in standard post cardiac rehabilitation compared to the increased rates of exercise compliance observed with the help of smartphone applications | 6 Months | ||
| Primary | Difference in Diastolic blood pressure in subjects who have received andard post cardiac rehabilitation compared to of exercise compliance observed with the help of smartphone applications | 6 Months |
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