Pulmonary Arterial HypertensionMhOVE-PPHNCT06549452
Mobile Health Intervention to Improve Exercise in Pediatric PH
A study testing mHealth Intervention in people with Pulmonary Arterial Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- mHealth Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Natasha Billard, 434-851-3306, natasha.billard.1@vumc.org
Eric Austin, MD, (615) 343-7617, eric.austin@vumc.org
About this study
Official title: MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
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
- Being tested
- mHealth Intervention, Usual Care
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionDevice
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 CareDevice
Routine medical care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mHealth Intervention |
| Usual Care | Other | Routine medical care Receives: Device: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (15)
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
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Difference in total daily activity from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on total daily activity time from baseline to 12 weeks. Activity time is defined as time spent above 3 metabolic equivalents.
Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Activity time 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.
Measured: Baseline to 12 weeks
Difference in unadjusted raw daily steps from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on unadjusted change in raw daily steps from baseline to 12 weeks.
Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Step counts and 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.
Measured: Baseline to 12 weeks
Difference in total daily aerobic time from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on total daily aerobic time from baseline to 12 weeks. Aerobic time is defined as the total time spent walking continuously for > 10 minutes without breaking for > 1 minute.
Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Aerobic time 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.
Measured: Baseline to 12 weeks
Difference in frequency of goal attainment from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on frequency (% days) of goal attainment from baseline to 12 weeks.
Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Frequency (% days) of goal attainment 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.
Measured: Baseline to 12 weeks
Difference in mean daily steps during week 12 and week 18
To assess the effect of a mHealth intervention or no intervention on mean daily steps during week 12 and week 18.
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.
Measured: Week 12 & Week 18
Difference in B-type natriuretic peptide levels from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on B-type natriuretic peptide levels (pg/mL) between baseline and 12 weeks.
Measured: Baseline to 12 weeks
Difference in 6-Minute walk test distance from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on the 6-minute walk test distance (meters) between baseline and 12 weeks.
Measured: Baseline to 12 weeks
Difference in Echocardiographic pericardial effusion from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on Echocardiographic pericardial effusion from baseline to 12 weeks.
Measured: Baseline to 12 weeks
Difference in Echocardiographic maximal tricuspid regurgitant velocity from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on Echocardiographic maximal tricuspid regurgitant velocity from baseline to 12 weeks.
Measured: Baseline to 12 weeks
Difference in Echocardiographic measurement of RV fractional area change (FAC) from baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on Echocardiographic measurement of RV fractional area change (FAC) from baseline to 12 weeks.
Measured: Baseline to 12 weeks
Time to clinical worsening
To assess the effect of a mHealth intervention or no intervention on a composite outcome of PAH-related hospitalization, medication regimen escalation, decrease in vital status, and all-cause mortality at 12 weeks after randomization. Clinical worsening events are defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), escalation in WHO functional class, and initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Dec 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Eric Austin, Vanderbilt University Medical Center
- Investigators
- Eric Austin, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549452
- Sponsor's protocol ID
- 240771
- Other IDs
- 1R34HL173389
- Acronym
- MhOVE-PPH
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
- ClinicalTrials.gov ID
- NCT06549452
- Acronym / sponsor ID
- MhOVE-PPH / 240771
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention | Active comparator | Device: mHealth InterventionPatients 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. |
| Usual Care | Other | Device: Usual CareRoutine medical care |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth InterventionOur 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. | Device | mHealth Intervention |
| Usual CareRoutine medical care | Device | Usual Care |
Primary outcome
Change in average daily step count from baseline to 12 weeks
Time frame: 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.
15 secondary outcomes
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
Difference in Echocardiographic maximal tricuspid regurgitant velocity from baseline to 12 weeks
Time frame: Baseline to 12 weeks
Difference in Echocardiographic measurement of RV fractional area change (FAC) from baseline to 12 weeks
Time frame: Baseline to 12 weeks
Time to clinical worsening
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Austin, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention in people with Pulmonary Arterial Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Billard ((434) 851-3306, natasha.billard.1@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily step count from baseline to 12 weeks (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.