CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Smartphone Text Messaging +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03069716
NCT03069716N/ACompleted
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A Mobile Health Intervention in Pulmonary Arterial Hypertension

Vanderbilt University Medical Center·interventional·Posted Mar 3, 2017·Updated Jun 25, 2021

In Brief

A clinical study evaluating Smartphone Text Messaging and Fitbit Charge HR for Pulmonary Arterial Hypertension and 3 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Associated Pulmonary Arterial Hypertension
CountriesUnited States
CollaboratorsJohns Hopkins University

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartAug 2, 2017
Primary CompletionApr 24, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.3 years ago

Interventions

Smartphone Text Messagingdevice

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.

Fitbit Charge HRdevice

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.