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A Mobile Health Intervention in Pulmonary Arterial Hypertension

NCT03069716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-06-25

Study results available
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Summary

This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.

Conditions

  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Arterial Hypertension
  • Heritable Pulmonary Arterial Hypertension
  • Associated Pulmonary Arterial Hypertension

Interventions

DEVICE

Smartphone Text Messaging

A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

DEVICE

Fitbit Charge HR

The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive.

Sponsors & Collaborators

Principal Investigators

  • Evan Brittain, MD, MSc · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2020-04-24
Completion
2020-04-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069716 on ClinicalTrials.gov