A Mobile Health Intervention in Pulmonary Arterial Hypertension

Completed · Not applicable

Conditions studied: Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Associated Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT03069716

Run by

Vanderbilt University Medical Center

People needed

49

Starts

2017-08-02

Expected to finish

2020-04-24

Last updated by the study team

2021-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 or older.
• Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
• Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
• Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.

You may not qualify if…

• Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
• Pregnancy.
• Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
• Forced vital capacity <70% predicted.
• Functional class IV heart failure.
• Requirement of > 1 diuretic adjustment in the prior three months.
• Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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