Mobile Health Intervention to Improve Exercise in Pediatric PH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mHealth Intervention, Usual Care.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: 10 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
Overview
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.
Interventions
- Device 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 proport - Device Usual Care
Routine medical care
Primary outcome measures
- Change in average daily step count from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
Secondary outcome measures (12)
- Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36) [Time frame: Baseline to 12 weeks]
- Change in Quality of Life as measured by the emPHasis-10 [Time frame: Baseline to 12 weeks]
- Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) [Time frame: Baseline to 12 weeks]
- Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP) [Time frame: Baseline to 12 weeks]
- Difference in total daily activity from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in unadjusted raw daily steps from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in total daily aerobic time from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in frequency of goal attainment from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in mean daily steps during week 12 and week 18 [Time frame: Week 12 & Week 18]
- Difference in B-type natriuretic peptide levels from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in 6-Minute walk test distance from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
- Difference in Echocardiographic pericardial effusion from baseline to 12 weeks [Time frame: Baseline to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06549452 · 240771 · 1R34HL173389