Clinical trial NCT06549452: Mobile Health Intervention to Improve Exercise in Pediatric PH
Official title: MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in average daily step count from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36)
timeFrame: Baseline to 12 weeks
measure: Change in Quality of Life as measured by the emPHasis-10
timeFrame: Baseline to 12 weeks
measure: Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline to 12 weeks
measure: Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP)
timeFrame: Baseline to 12 weeks
measure: Difference in total daily activity from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in unadjusted raw daily steps from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in total daily aerobic time from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in frequency of goal attainment from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in mean daily steps during week 12 and week 18
timeFrame: Week 12 & Week 18
measure: Difference in B-type natriuretic peptide levels from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in 6-Minute walk test distance from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in Echocardiographic pericardial effusion from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in Echocardiographic maximal tricuspid regurgitant velocity from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Difference in Echocardiographic measurement of RV fractional area change (FAC) from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Time to clinical worsening
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Eric Austin, MD
role: PRINCIPAL_INVESTIGATOR
References: