Cardiopulmonary Outpatient Rehabilitation Using Mobile Technology

NCT ID: NCT02671669

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-03-01

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.

Conditions

Cardiac Disease; Pulmonary Disease; Cardiopulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care (UC)

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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)

Group Type: ACTIVE_COMPARATOR

Movn application (MVN)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Bushnik, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-01809

Identifier Type: -

Identifier Source: org_study_id