Improving adherence through mHealth for pediatric hematopoietic stem cell transplant patients - PROJECT SUMMARY/ABSTRACT
An estimated 50-80% of all pediatric patients are non-adherent.3-6 Extensive pediatric adherence research
exists in solid organ transplant, cystic fibrosis, diabetes, and other chronic illnesses. However, there are only
three known studies in children with HSCT, and all report suboptimal adherence rates (52-78%) that worsen
over time.7-9 Additionally, in pilot study, 70% of HSCT providers reported adherence as a major concern for
their outpatient pediatric HSCT recipients.10 Currently, no HSCT specific interventions exist to improve
adherence and clinical outcomes. There is a critical need to evaluate novel mHealth approaches to improve
adherence and clinical outcomes among children receiving hematopoietic stem cell transplant (HSCT) to
prevent morbidity and mortality. The rationale is that a mHealth app designed to send medication reminders to
caregivers will increase adherence to immunosuppressant medication, thereby potentially reducing GVHD,
readmissions, and mortality. The app will also obtain reasons for non-adherence adding to our knowledge of
barriers to adherence in this population. This K99/R00 application describes the background and experience of
the applicant, Micah A. Skeens PhD, RN, and her plan to acquire the knowledge and training necessary to
become a leading independent clinical investigator in adherence and mHealth interventions that improve
clinical outcomes for children undergoing hematopoietic stem cell transplant (HSCT). The overall goal during
the K99 is to gain advanced research training in mHealth interventions, adherence and conducting randomized
controlled trials (RCTs) to develop and test a mHealth application for adherence of pediatric HSCT patients in
the acute phase post-transplant. Using a behavioral economics approach, the goal of this new mHealth
application will be to improve adherence and ultimately clinical outcomes as well as collect information
regarding barriers. The research specific aim during the K99 phase is to develop an adherence mHealth
application using a mixed methods approach and to evaluate the usability and acceptability of the mHealth
application for pediatric HSCT patients in the acute outpatient phase post-transplant. To meet the K99 training
objectives, a comprehensive training plan has been developed in concert with an internationally recognized
interdisciplinary mentorship team of senior research experts. The overall goal during the R00 phase is to
conduct a pilot RCT with 40 caregivers to assess acceptability, feasibility and potential efficacy of the newly
developed mHealth app. The research specific aims during the R00 phase are to: 1) evaluate the acceptability
of a newly developed mHealth app and the feasibility of enrolling and retaining 40 caregivers of children in the
acute outpatient phase post-HSCT and 2) evaluate the potential efficacy of the mHealth app on adherence to
immunosuppressants in children who have been discharged home during the acute phase post-HSCT. The
results will directly support an R-01 application to conduct a multi-site RCT efficacy trial of the mHealth
application on adherence and clinical outcomes in children during the acute phase post-HSCT.
