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.
In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions and an estimated 50-80% of pediatric patients are non-adherent. Behavioral economics (BE) suggests that small ?nudges? or reminders can produce and sustain behavior change, thus with mobile health (mHealth) access nearly ubiquitous and an estimated 3.7 billion mHealth application downloads in 2017 alone,13 technology has great potential to improve adherence. Nurses could easily deliver these universal mHealth intervention approaches as a frontline approach to family education and care, addressing the critical need to improve adherence and clinical outcomes among children to ultimately prevent morbidity and mortality.
