RecruitingNot ApplicableNCT06549452

Mobile Health Intervention to Improve Exercise in Pediatric PH

MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH


Sponsor

Vanderbilt University Medical Center

Enrollment

50 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.


Eligibility

Min Age: 10 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mobile health app and wearable device program to help teenagers with pulmonary arterial hypertension (PAH) — a condition where blood pressure in the lungs is dangerously high — stay more physically active. Regular exercise is beneficial for PAH patients, but many avoid it out of fear. The study hopes to show that a safe, guided mobile program can improve exercise habits. **You may be eligible if...** - You are an adolescent between 13 and 19 years old - You have been diagnosed with PAH (idiopathic, heritable, or related to connective tissue disease, drugs, toxins, or simple congenital heart disease like atrial septal defect) - Your PAH is classified as WHO functional class I–III (not the most severe) - Your PAH medication has been stable for at least 3 months - Your lung function and breathing tests are within an acceptable range **You may NOT be eligible if...** - You are confined to a wheelchair or bed - You are currently on an urgent transplant waitlist - You have other conditions that make physical activity unsafe - Your PAH medication has recently changed significantly 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

Our HIPPA-compliant texting platform is linked to the Fitabase Interface. Real time activity data are transmitted from the participant's smartphone to Fitabase via cellular network. Participants will receive 3-5 texts/day in sync with their preferred schedule defined at enrollment and taking into account school schedules as relevant. These texts use personal, disease-specific, and provider information to deliver two 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

Routine medical care


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06549452


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