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Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671669
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Pulmonary Disease Cardiopulmonary Disease Behavioral: Usual Care Behavioral: Movn application (MVN) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Empowering Individuals Post-Cardiopulmonary Outpatient Rehabilitation to Continue to Live a Heart Healthy Lifestyle: Utilizing Mobile Health Technology
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671669


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Tamara Bushnik, MD New York University Medical School
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02671669    
Other Study ID Numbers: 14-01809
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Pulmonary Heart Disease
Cardiovascular Diseases