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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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology
Official Title  ICMJE Empowering Individuals Post-Cardiopulmonary Outpatient Rehabilitation to Continue to Live a Heart Healthy Lifestyle: Utilizing Mobile Health Technology
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiac Disease
  • Pulmonary Disease
  • Cardiopulmonary Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Usual Care (UC)
    Intervention: Behavioral: Usual Care
  • Active Comparator: Movn application (MVN)
    Intervention: Behavioral: Movn application (MVN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2019)
67
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
100
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671669
Other Study ID Numbers  ICMJE 14-01809
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tamara Bushnik, MD New York University Medical School
PRS Account NYU Langone Health
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP