Recruiting

Mobile Health Intervention

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06549452

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Interventions

mHealth Intervention

Usual Care

Study Details

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 ID

NCT06549452

Start date

Dec 1, 2024

Status verified date

Mar, 2026

Completion date

Nov 1, 2030

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Usual Care

Routine medical care

Primary outcome measure

  • Change in average daily step count from baseline to 12 weeks [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Natasha Billard

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

Eric Austin, MD

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Natasha Billard

434-851-3306natasha.billard.1@vumc.org

Eric Austin, MD

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

Principal Investigator:

Eric Austin, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-03-27.