Mobile Health Intervention to Improve Exercise in Pediatric PH
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-21
SponsorVanderbilt University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
mHealth Intervention
DeviceOur 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
DeviceRoutine medical care
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: mHealth InterventionActive comparator 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
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.
Time frame
Baseline to 12 weeksSecondary outcomes
1
Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36)
To assess the effect of a mHealth intervention or no intervention on quality of life between baseline and Week 12. The SF36 is one of the most widely used generic measures of subjective health status. The SF36 includes one multi-item scale that assesses eight health concepts. Scoring the SF 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per a scoring key. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the low
Time frame
Baseline to 12 weeks2
Change in Quality of Life as measured by the emPHasis-10
To assess the effect of a mHealth intervention or no intervention on quality of life between baseline and Week 12. The emPHasis-10 is a pulmonary hypertension-specific questionnaire to assess health related quality of life. It covers breathlessness, fatigue and lack of energy, social restrictions, and concerns regarding effects on patient's significant others, such as family and friends. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Time frame
Baseline to 12 weeks3
Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL)
To assess the effect of a mHealth intervention or no intervention on quality of life between baseline and Week 12. The Pediatric Quality of Life Inventory (PedsQL) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL integrates seamlessly both generic core scales and disease-specific modules into one measurement system, which generally takes about 4 minutes to complete. Each item is scored on a 5-point Likert scale from 0 (Never) to 4 (Almost always), then reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better health-related quality of life.
Time frame
Baseline to 12 weeks4
Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP)
To assess the effect of a mHealth intervention or no intervention on quality of life between baseline and Week 12. The PIP is a questionnaire comprising 42 items, grouped into four domains or subscales: medical care, communication, emotional functioning, and role function. Its purpose is to measure the levels of stress suffered by parents caring for a child with a chronic disease. Responses are provided using a five-point Likert scale, ranging from 1 ("never/not at all") to 5 ("very often/extremely"). Higher scores indicate higher levels of stress.
Time frame
Baseline to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
University of California, San Francisco
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov