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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 19
Healthy Volunteers: f
View:

• Adolescents between ages 13-19 years.

• 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.

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Natasha Billard
natasha.billard.1@vumc.org
(434) 851-3306
Backup
Eric Austin, MD
eric.austin@vumc.org
(615) 343-7617
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 50
Treatments
Active_comparator: mHealth Intervention
Patients will be randomized to the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Other: Usual Care
Routine medical care
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco

This content was sourced from clinicaltrials.gov