NCT02671669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

January 28, 2016

Last Update Submit

May 21, 2020

Conditions

Cardiac DiseasePulmonary DiseaseCardiopulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 Months

Study Arms (2)

Usual Care (UC)

ACTIVE COMPARATOR
Behavioral: Usual Care

Movn application (MVN)

ACTIVE COMPARATOR
Behavioral: Movn application (MVN)

Interventions

Usual CareBEHAVIORAL

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.

Usual Care (UC)
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.

Movn application (MVN)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Heart DiseasesLung DiseasesPulmonary Heart Disease

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiratory Tract Diseases

Study Officials

  • Tamara Bushnik, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

August 31, 2017

Study Completion

March 1, 2018

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

US(1)