Mobile Health Intervention for Pediatric PAH

(MhOVE-PPH Trial)

Overseen By Eric Austin, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: PAH-specific medications

Disqualifiers: Wheelchair bound, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have a stable PAH-specific medication regimen for three months before joining the trial, with only minor adjustments allowed.

What data supports the effectiveness of the mHealth Intervention treatment for Pediatric PAH?

Research shows that mobile health (mHealth) interventions have been effective in managing chronic diseases in children, such as obesity and asthma, by improving health behaviors and monitoring. This suggests that similar mHealth approaches could be beneficial for managing Pediatric PAH (Pulmonary Arterial Hypertension). ^{1 2 3 4 5}

Is the mobile health intervention generally safe for use in humans?

The research on mobile health (mHealth) interventions, while focused on different conditions like obesity and physical inactivity, suggests they are generally safe for use in humans. However, challenges such as data security, patient privacy, and potential increased screen time need to be considered. ^{6 7 8 9 10}

How is the mHealth Intervention treatment for Pediatric PAH different from other treatments?

The mHealth Intervention for Pediatric PAH is unique because it uses mobile technology to deliver health programs, making it more accessible and potentially more engaging for children and adolescents. Unlike traditional treatments, it focuses on self-management and behavior change through interactive apps, which can be tailored to individual needs and preferences. ^{6 11 12 13 14}

What is the purpose of 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.

Research Team

Eric Austin, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adolescents aged 13-19 with pulmonary arterial hypertension (PAH). They must have been on a stable PAH medication regimen for at least three months and have a WHO functional class of I-III. It's open to those with idiopathic, heritable, or associated PAH, as well as PAH from simple congenital heart disease.

Inclusion Criteria

WHO functional class I-III

I am between 13 and 19 years old.

My PAH medication has been stable for 3 months, with only minor adjustments.

Exclusion Criteria

My diuretic medication has been adjusted more than twice in the last three months.

Involved in any other investigational intervention

I cannot do normal activities because I use a wheelchair, walker, or have severe pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mobile health intervention to increase step counts, monitored using a Fitbit device

12 weeks

Remote monitoring

Follow-up

Participants are monitored for changes in quality of life and clinical outcomes after the intervention

4 weeks

Treatment Details

Interventions

• mHealth Intervention

Trial Overview The study tests an mHealth intervention designed to increase daily activity in young patients with PAH. Participants will receive this mobile health program tailored to their age group and compare its effects on step counts against usual care without the intervention.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Routine medical care

Group II: mHealth Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A scoping review of 45 systematic reviews and meta-analyses found that e-health and m-health interventions are widely used to address childhood obesity, with a focus on weight, physical activity, and diet, but only a small percentage evaluated cost-effectiveness.

Most reviews (97%) had critically low or low methodological quality, highlighting the need for future studies to identify effective components of these interventions and to assess broader metrics beyond just efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-&mHealth interventions targeting nutrition, physical activity, sedentary behavior, and/or obesity among children: A scoping review of systematic reviews and meta-analyses. Kracht, CL., Hutchesson, M., Ahmed, M., et al.[2022]

This systematic review evaluated seven studies involving 755 children with chronic diseases and found that user-focused mobile health (mHealth) applications can lead to clinically meaningful improvements in some health outcomes, although results varied widely across different conditions.

Despite some positive effects, the overall risk of bias in the studies was high, making it difficult to draw definitive conclusions about which specific populations would benefit most from these mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. Karataş, N., Kaya, A., İşler Dalgıç, A.[2022]

The iAmHealthy intervention is a unique, family-based program designed specifically for rural children, addressing pediatric obesity through mobile health applications over an 8-month period, involving 144 children across 18 schools.

This study is the first randomized controlled trial to implement a rural-focused, mHealth intervention for pediatric obesity, measuring outcomes like Body Mass Index z-score (BMIz) and physical activity, with data collected at multiple time points to assess effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Davis, AM., Beaver, G., Dreyer Gillette, M., et al.[2020]

A scoping review of 25 clinical trials from 2016 to 2021 found that mobile health (mHealth) technology is effectively used for remote patient monitoring (RPM) in pediatric asthma, especially during the COVID-19 pandemic.

The quality of studies has improved, with 40% being randomized controlled trials, indicating a growing body of high-quality evidence supporting the efficacy of mHealth-enabled RPM in managing pediatric asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic. Dauletbaev, N., Oftring, ZS., Akik, W., et al.[2022]

A review of 11 studies identified six key technical factors that influence children's adherence to nonpharmacological treatments for chronic pulmonary diseases when using mobile health technology, including app design, technical support, and privacy concerns.

To improve adherence, mHealth applications should be tailored to meet the specific needs of pediatric patients, addressing barriers related to connectivity and cultural readiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Factors That May Influence mHealth Adherence in Children With Chronic Pulmonary Diseases: Scoping Review. Sapouna, V., Dimitriadis, Z., Douros, K., et al.[2023]

Mobile health (mHealth) and telehealth interventions, such as wearable trackers and apps, have the potential to increase physical activity among adolescents, but user engagement is often low and needs improvement.

While these interventions are scalable and generally accepted, they face challenges in measuring effectiveness and ensuring consistent user participation, highlighting the need for better engagement strategies in future designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health and Telehealth Interventions to Increase Physical Activity in Adolescents with Obesity: a Promising Approach to Engaging a Hard-to-Reach Population. Vajravelu, ME., Arslanian, S.[2022]

In a 6-month mHealth randomized controlled trial involving 2920 caregivers in China, the attrition rate was lower in the intervention group (28.9%) compared to the control group (35.7%), indicating that the app-based intervention may help retain participants better.

Factors influencing attrition included lower engagement with the app, such as fewer knowledge segments learned and lower login frequency, suggesting that enhancing participant engagement could reduce dropout rates in future mHealth studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial. Li, J., Ning, P., Cheng, P., et al.[2021]

mHealth interventions that are highly individualized can significantly reduce insufficient physical activity (IPA) levels in children and adolescents, with a moderate effect size (Cohen d=0.33) based on a meta-analysis of 10 studies involving 1515 participants.

In contrast, mHealth interventions with low levels of individualization or those targeting sedentary behavior (SB) showed no significant effects, highlighting the importance of tailoring interventions to individual needs for effective behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Reduce Physical Inactivity and Sedentary Behavior in Children and Adolescents: Systematic Review and Meta-analysis of Randomized Controlled Trials. Baumann, H., Fiedler, J., Wunsch, K., et al.[2022]

This study aims to develop a mobile health (mHealth) intervention targeting high school students to promote healthy lifestyle changes, addressing multiple unhealthy behaviors like poor diet and lack of physical activity.

The research emphasizes a participatory design approach, involving high school students in the development process to ensure the intervention is user-friendly and appealing, with results expected to inform a clinical trial starting in Summer 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Mobile Devices to Deliver Lifestyle Interventions Targeting At-Risk High School Students: Protocol for a Participatory Design Study. Müssener, U., Löf, M., Bendtsen, P., et al.[2020]

mHealth systems present innovative opportunities for addressing childhood obesity through cost-effective interventions and real-time data collection, but they also face challenges such as a lack of scientific evidence for effectiveness and concerns over data security and privacy.

To maximize the benefits of mHealth in combating childhood obesity, researchers, health practitioners, and policymakers need to collaborate, focusing on developing secure technologies, regulating app quality, and creating effective partnerships between academia and industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. Tate, EB., Spruijt-Metz, D., O'Reilly, G., et al.[2022]

A systematic review identified 7 mHealth apps for children and adolescents with chronic pulmonary diseases, primarily focusing on asthma and cystic fibrosis, highlighting the need for more targeted digital health solutions.

While these apps cover important areas like education and treatment support, they currently lack robust features to enhance disease self-management and treatment compliance among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health applications designed for self-management of chronic pulmonary diseases in children and adolescents: a systematic mapping review. Sapouna, V., Kitixis, P., Petrou, E., et al.[2023]

Youth often engage only partially with mobile health (mHealth) interventions, which can hinder behavior change and affect the evaluation of intervention efficacy, particularly in HIV prevention and care.

The study emphasizes the need for systematic tracking of user engagement through paradata and outlines strategies to enhance engagement, ensuring that key features of mHealth interventions are effectively designed and evaluated for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging youth in mHealth: what works and how can we be sure? Hightow-Weidman, LB., Horvath, KJ., Scott, H., et al.[2023]

The review analyzed 54 studies on mobile health (mHealth) programs promoting physical activity, identifying 31 methods to measure user adherence, which were categorized into 8 indicators across 4 dimensions.

Adherence to mHealth programs is significantly linked to positive health outcomes, and a new framework was developed to help understand and measure adherence, which could guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of Adherence to mHealth Physical Activity Interventions and Exploration of the Factors That Affect the Adherence: Scoping Review and Proposed Framework. Yang, Y., Boulton, E., Todd, C.[2022]

In a six-month feasibility trial involving 28 children aged 5-12, an mHealth support system combined with standard care led to a significant reduction in BMI SDS by 0.24 units compared to no change in the control group, indicating its effectiveness in pediatric obesity treatment.

The mHealth approach improved appointment attendance and was well-received by both parents and clinicians, suggesting it is a feasible and accessible option for enhancing traditional obesity treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. Johansson, L., Hagman, E., Danielsson, P.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

E-&mHealth interventions targeting nutrition, physical activity, sedentary behavior, and/or obesity among children: A scoping review of systematic reviews and meta-analyses. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Technical Factors That May Influence mHealth Adherence in Children With Chronic Pulmonary Diseases: Scoping Review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mobile Health and Telehealth Interventions to Increase Physical Activity in Adolescents with Obesity: a Promising Approach to Engaging a Hard-to-Reach Population. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Reduce Physical Inactivity and Sedentary Behavior in Children and Adolescents: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Using Mobile Devices to Deliver Lifestyle Interventions Targeting At-Risk High School Students: Protocol for a Participatory Design Study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Mobile health applications designed for self-management of chronic pulmonary diseases in children and adolescents: a systematic mapping review. [2023]

12. China pubmed.ncbi.nlm.nih.gov

Engaging youth in mHealth: what works and how can we be sure? [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

Measurement of Adherence to mHealth Physical Activity Interventions and Exploration of the Factors That Affect the Adherence: Scoping Review and Proposed Framework. [2022]

14. England pubmed.ncbi.nlm.nih.gov

A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. [2021]