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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Usual Care
Discharge packet of Heart Healthy instructions, with self-report health status, quality of life and psychosocial questionnaires, as well as other educational handouts, exit interview to review exercise progress, receive referrals to additional medical services they might need after discharge from the program, with physician.
Movn application (MVN)
Intervention participants will receive the same discharge packet as the UC group along with their exit interview and will receive the following: Participant individualized Heart Healthy instructions for post-cardiac rehabilitation will be integrated into the MVN application including daily medication reminders, physical activity prompts, educational materials, and patient-reported outcome assessment of behavior and psychosocial status. Text messages will be used on an ad hoc basis to provide positive feedback to the participant; two-way messaging between the participant and the research coordinator will be available to provide opportunities to answer specific questions.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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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