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OpenTrials
Completed

NCT Number: NCT02671669

Cardiopulmonary Outpatient Rehabilitation Using Mobile 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.

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Key information

Conditions

Cardiac Disease Cardiopulmonary Disease Cardiovascular Diseases Heart Diseases Lung Diseases Pulmonary Disease Pulmonary Heart Disease Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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

    Time frame: 6 Months

  2. 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

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 2, 2016
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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