Mobile health intervention for patients with pulmonary arterial hypertension
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
This study is testing whether a mobile health program using smart texts can help people with pulmonary arterial hypertension feel better and move more compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05464095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a diagnosis of pulmonary arterial hypertension who are in WHO functional class I-III and have a stable medication regimen.
Not a fit: Patients who are wheelchair-bound, bed-bound, or have other conditions that severely limit their physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and physical activity levels for patients with pulmonary arterial hypertension.
How similar studies have performed: Previous studies have shown that mobile health interventions can effectively improve health outcomes in various chronic conditions, suggesting potential success for this novel approach in PAH.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.