Mobile Health Intervention for Pediatric PAH
(MhOVE-PPH Trial)
Recruiting in Palo Alto (17 mi)
Overseen byEric Austin, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Must be taking: PAH-specific medications
Disqualifiers: Wheelchair bound, Pregnancy, Heart failure, others
No Placebo Group
Trial Summary
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.
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).
12345Is 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.
678910How 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.
611121314Eligibility 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.
+2 more
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.
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual CareExperimental Treatment1 Intervention
Routine medical care
Group II: mHealth InterventionActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
University of California, San FranciscoCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
E-&mHealth interventions targeting nutrition, physical activity, sedentary behavior, and/or obesity among children: A scoping review of systematic reviews and meta-analyses. [2022]Childhood obesity is a public health concern. Electronic and mobile health (e-&mHealth) approaches can facilitate the delivery of interventions for obesity prevention and treatment. Synthesizing reviews of e-&mHealth interventions to improve weight and weight-related behaviors (physical activity, sedentary behavior, and diet) is useful to characterize the current scope of the literature and identify opportunities for future reviews and studies. Using a scoping review methodology, we aimed to evaluate the breadth and methodological quality of systematic reviews and meta-analyses of e-&mHealth interventions targeting weight and weight-related behaviors in children and adolescents aged
The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. [2022]This systematic review aims to evaluate the effectiveness of user-focused mobile health (mHealth) applications in paediatric chronic disease management.
iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. [2020]Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families that capitalizes on the innovative use of mobile health applications (mHealth). iAmHealthy is a 25-contact hour multicomponent intervention delivered over an 8-month period targeting 2nd-4th grade school children and their families. This paper describes the rationale, design, participant/school enrollment, and planned implementation of a randomized controlled trial of the iAmHealthy intervention in comparison to a monthly newsletter delivered through rural elementary schools. Child Body Mass Index z-score (BMIz) is the primary outcome, along with child 24-hour dietary recall, and child accelerometer-determined physical activity and sedentary behavior as secondary outcomes. The study will include 18 schools (with 8 children each) resulting in a final planned sample size of 144 children. This project also has a strong focus on dissemination and implementation science, and thus includes many measures related to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Data collection is completed at baseline, end of intervention (8 months), and follow-up (20 months). This study is the first randomized controlled trial to deliver a rurally tailored, empirically supported, family-based behavioral intervention for pediatric obesity solely over mHealth. Registered with ClinicalTrials.gov NCT ID 03304249.
A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic. [2022]Mobile (m) Health technology is well-suited for Remote Patient Monitoring (RPM) in a patient's habitual environment. In recent years there have been fast-paced developments in mHealth-enabled pediatric RPM, especially during the COVID-19 pandemic, necessitating evidence synthesis. To this end, we conducted a scoping review of clinical trials that had utilized mHealth-enabled RPM of pediatric asthma. MEDLINE, Embase and Web of Science were searched from September 1, 2016 through August 31, 2021. Our scoping review identified 25 publications that utilized synchronous and asynchronous mHealth-enabled RPM in pediatric asthma, either involving mobile applications or via individual devices. The last three years has seen the development of evidence-based, multidisciplinary, and participatory mHealth interventions. The quality of the studies has been improving, such that 40% of included study reports were randomized controlled trials. In conclusion, there exists high-quality evidence on mHealth-enabled RPM in pediatric asthma, warranting future systematic reviews and/or meta-analyses of the benefits of such RPM.
Technical Factors That May Influence mHealth Adherence in Children With Chronic Pulmonary Diseases: Scoping Review. [2023]To synthesize the technical factors influencing adherence to nonpharmacological treatment (NPhT) in children with chronic pulmonary diseases (CPDs), using mobile health (mHealth) technology.
Mobile Health and Telehealth Interventions to Increase Physical Activity in Adolescents with Obesity: a Promising Approach to Engaging a Hard-to-Reach Population. [2022]Adolescence represents a critical time to set habits for long-term health, yet adequate rates of physical activity are uncommon in this age group. Mobile technology use, however, is ubiquitous. We review advantages and challenges posed by mobile health (mHealth) and telehealth-based physical activity interventions aimed at adolescents.
Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial. [2021]Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies.
mHealth Interventions to Reduce Physical Inactivity and Sedentary Behavior in Children and Adolescents: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]Children and adolescents increasingly do not meet physical activity (PA) recommendations. Hence, insufficient PA (IPA) and sedentary behavior (SB) among children and adolescents are relevant behavior change domains for using individualized mobile health (mHealth) interventions.
Using Mobile Devices to Deliver Lifestyle Interventions Targeting At-Risk High School Students: Protocol for a Participatory Design Study. [2020]Unhealthy lifestyle behaviors such as insufficient physical activity, unhealthy diet, smoking, and harmful use of alcohol tend to cluster (ie, individuals may be at risk from more than one lifestyle behavior that can be established in early childhood and adolescence and track into adulthood). Previous research has underlined the potential of lifestyle interventions delivered via mobile phones. However, there is a need for deepened knowledge on how to design mobile health (mHealth) interventions taking end user views into consideration in order to optimize the overall usability of such interventions. Adolescents are early adopters of technology and frequent users of mobile phones, yet research on interventions that use mobile devices to deliver multiple lifestyle behavior changes targeting at-risk high school students is lacking.
mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]Childhood obesity continues to be a significant public health issue. mHealth systems offer state-of-the-art approaches to intervention design, delivery, and diffusion of treatment and prevention efforts. Benefits include cost effectiveness, potential for real-time data collection, feedback capability, minimized participant burden, relevance to multiple types of populations, and increased dissemination capability. However, these advantages are coupled with unique challenges. This commentary discusses challenges with using mHealth strategies for child obesity prevention, such as lack of scientific evidence base describing effectiveness of commercially available applications; relatively slower speed of technology development in academic research settings as compared with industry; data security, and patient privacy; potentially adverse consequences of increased sedentary screen time, and decreased focused attention due to technology use. Implications for researchers include development of more nuanced measures of screen time and other technology-related activities, and partnering with industry for developing healthier technologies. Implications for health practitioners include monitoring, assessing, and providing feedback to child obesity program designers about users' data transfer issues, perceived security and privacy, sedentary behavior, focused attention, and maintenance of behavior change. Implications for policy makers include regulation of claims and quality of apps (especially those aimed at children), supporting standardized data encryption and secure open architecture, and resources for research-industry partnerships that improve the look and feel of technology. Partnerships between academia and industry may promote solutions, as discussed in this commentary.
Mobile health applications designed for self-management of chronic pulmonary diseases in children and adolescents: a systematic mapping review. [2023]Mobile health (mHealth) applications are scarce for children and adolescents with chronic pulmonary diseases (CPDs). This study aimed to map and describe the contents of the mHealth apps available for use in children and adolescents with CPDs.
Engaging youth in mHealth: what works and how can we be sure? [2023]Youth participating in mobile health (mHealth) intervention trials often engage with the technologies [e.g., applications (app) or mobile-optimized websites] only partially, often prematurely discontinuing use altogether. Limited engagement can impact the interventions effect on behavior change and compromise researchers' ability to test and estimate the true efficacy of their interventions. While mHealth interventions have been shown to be feasible and acceptable to youth, across diverse health conditions, strategies to increase engagement have been less well studied. Specifically, within HIV prevention and care mHealth interventions, there is not consensus as to which components represent the "key ingredients" to support maximal engagement of youth. Further, successful intervention evaluation requires the ability to systematically track users' engagement with intervention components (i.e., paradata) to evaluate its effects on behavior change.
Measurement of Adherence to mHealth Physical Activity Interventions and Exploration of the Factors That Affect the Adherence: Scoping Review and Proposed Framework. [2022]Mobile health (mHealth) is widely used as an innovative approach to delivering physical activity (PA) programs. Users' adherence to mHealth programs is important to ensure the effectiveness of mHealth-based programs.
A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. [2021]In order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment.