Mobile Health Intervention to Improve Exercise in Pediatric PH

NCT ID: NCT06549452

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2030-11-01

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

mHealth Intervention

Intervention Type: DEVICE

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.

Usual Care

Routine medical care

Group Type: OTHER

Usual Care

Intervention Type: DEVICE

Routine medical care

Interventions

mHealth 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.

Intervention Type: DEVICE

Usual Care

Routine medical care

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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).
• Involved in any other investigational intervention.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Austin

Director, Vanderbilt Pediatric Pulmonary Hypertension Program (Allergy/Immunology/Pulmonary Medicine) and Associate Professor of Pediatrics (Allergy/Immunology/Pulmonary Medicine)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Austin, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Natasha Billard

Role: CONTACT

natasha.billard.1@vumc.org

(434) 851-3306

Eric Austin, MD

Role: CONTACT

eric.austin@vumc.org

(615) 343-7617

Facility Contacts

Natasha Billard

Role: primary

natasha.billard.1@vumc.org

434-851-3306

Eric Austin, MD

Role: backup

eric.austin@vumc.org

(615) 343-7617

Other Identifiers

1R34HL173389

Identifier Type: NIH

Identifier Source: secondary_id

View Link

240771

Identifier Type: -

Identifier Source: org_study_id