Mobile Health Intervention to Improve Exercise in Pediatric PH

NCT06549452 | Recruiting DMC

• 2 other identifiers: 2407711R34HL173389
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in average daily step count from baseline to 12 weeks

  To assess the effect of a mHealth intervention or no intervention on average daily step count from baseline to 12 weeks. Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Step counts will be measured using the Fitbit device monitor, a lightweight device that has a three-axis acceleration sensor, altimeter, vibration motor, and optical heart rate monitor.

  Baseline to 12 weeks

Secondary Outcomes (15)

• Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36)

  Baseline to 12 weeks

• Change in Quality of Life as measured by the emPHasis-10

  Baseline to 12 weeks

• Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL)

  Baseline to 12 weeks

• Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP)

  Baseline to 12 weeks

• Difference in total daily activity from baseline to 12 weeks

  Baseline to 12 weeks

Study Arms (2)

mHealth Intervention

ACTIVE COMPARATOR

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.

Device: mHealth Intervention

Usual Care

OTHER

Routine medical care

Device: Usual Care

Interventions

mHealth Intervention 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.

mHealth Intervention

Usual Care DEVICE

Routine medical care

Usual Care

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents between ages 10-21 years.
• Diagnosed with WHO Group 1 PAH or WHO Group 4 PH (CTEPH)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of California, San Francisco: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric Austin, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Billard

CONTACT

(434) 851-3306; natasha.billard.1@vumc.org

Eric Austin, MD

CONTACT

(615) 343-7617; eric.austin@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Vanderbilt Pediatric Pulmonary Hypertension Program (Allergy/Immunology/Pulmonary Medicine) and Associate Professor of Pediatrics (Allergy/Immunology/Pulmonary Medicine)

Model Details: Randomized, un-blinded, parallel group, Phase II study of 50 subjects with PAH. Eligible subjects will be randomly assigned to receive the mHealth intervention or usual care for twelve weeks.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)