Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

Empowering Individuals Post-Cardiopulmonary Outpatient Rehabilitation to Continue to Live a Heart Healthy Lifestyle: Utilizing Mobile Health Technology

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Cardiac Disease; Cardiopulmonary Disease
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Movn application (MVN)

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care (UC)	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.
Active Comparator: Movn application (MVN)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tamara Bushnik, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: 14-01809

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No