RecruitingNot ApplicableNCT05464095

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study


Sponsor

Vanderbilt University Medical Center

Enrollment

100 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease. The Investigators propose a randomized trial of smart texts versus usual care for 6 months. The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care. The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. The Investigators will also test the effect of an mHealth intervention on exercise capacity, measured by a supervised home-based 6MWD test. Finally, the Investigators will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a mobile health (app-based) exercise program can improve physical activity levels, exercise capacity, and quality of life in adults with pulmonary arterial hypertension (PAH) — a serious condition causing high blood pressure in the lungs. All participation is done remotely, making it accessible from home. **You may be eligible if...** - You are 18 or older with confirmed PAH (idiopathic, heritable, connective tissue disease-related, drug/toxin-related, or due to simple congenital heart disease) - Your PAH is classified as WHO functional class I–III (not the most severe stage) - Your PAH medications have been stable for 3 months **You may NOT be eligible if...** - Your PAH is caused by left heart disease, lung disease, or chronic blood clots - You are in WHO functional class IV (most severe) - You have had a recent hospitalization or significant health deterioration Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmHealth Intervention

The Health Insurance Portability and Accountability Act (HIPPA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network. Participants assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is 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.

DEVICEUsual Care

The HIPPA-compliant texting platform is linked to the Fitbit Application Program Interface. Real-time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT05464095


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