Mobile health intervention for patients with pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a mobile health intervention using smart texts compared to usual care for patients with pulmonary arterial hypertension (PAH). It aims to improve health-related quality of life (HRQOL) and exercise capacity over a six-month period. A total of 100 participants will be randomized to receive either the mHealth intervention or standard care, with outcomes measured using the PAH-specific emPHasis-10 questionnaire and a supervised home-based six-minute walk distance test. The study addresses the challenges of increasing physical activity in PAH patients, which is crucial for improving their overall health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 or older.
* Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
* WHO functional class I-III
* 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. Adjustments in IV prostacyclin for side effect management are allowed.
* Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.

Exclusion Criteria:

* 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 that limits activity.
* Pregnancy
* Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
* Functional class IV heart failure
* Requirement of \> 2 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's running

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

Study contacts

• Principal investigator: Evan Brittain, MD — Vanderbilt Medical Center
• Study coordinator: Alisha Lindsey, RT
• Email: alisha.lindsey@vumc.org
• Phone: 615-322-3412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sotatercept in Indian adults with pulmonary arterial hypertension on standard therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.