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Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

Primary Purpose

Cardiac Disease, Pulmonary Disease, Cardiopulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual Care

Movn application (MVN)

About this trial

This is an interventional prevention trial for Cardiac Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Usual Care (UC)

Movn application (MVN)

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02671669

First Posted

January 28, 2016

Last Updated

May 21, 2020

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02671669

Brief Title

Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

August 31, 2017 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Disease, Pulmonary Disease, Cardiopulmonary Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care (UC)

Arm Type

Active Comparator

Arm Title

Movn application (MVN)

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Movn application (MVN)

Intervention Description

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 Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamara Bushnik, MD

Organizational Affiliation

New York University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

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