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ENHANCE-(Electronic Hydroxyurea Adherence): A Protocol to Increase Hydroxyurea Adherence in Patients with Sickle Cell
Susan Creary1, Deena J Chisolm, Sarah H O'Brien
1Nationwide Children's Hospital, The Ohio State University School of Medicine, Columbus, OH, United States. susan.creary@nationwidechildrens.org.
Insights
Mobile Directly Observed Therapy (Mobile DOT) is an intervention to improve hydroxyurea (HU) adherence in children with sickle cell disease (SCD). This study evaluates Mobile DOT
Area of Science:
- Pediatric Hematology
- Chronic Disease Management
- Digital Health Interventions
Background:
- Hydroxyurea (HU) is the primary disease-modifying therapy for sickle cell disease (SCD), yet suboptimal adherence limits its effectiveness in pediatric patients.
- Adherence rates to HU in children with SCD range from 35% to 50%, highlighting a critical need for improved management strategies.
- Mobile Directly Observed Therapy (Mobile DOT) is an innovative, multidimensional intervention designed to address adherence challenges by integrating technology and behavioral science.
Purpose of the Study:
- To assess the impact of the Mobile DOT intervention on hydroxyurea (HU) adherence in pediatric patients diagnosed with sickle cell disease (SCD).
- To provide data that can inform the development of future adherence interventions and refine pediatric SCD treatment protocols.
Main Methods:
- A single-arm crossover study design was employed, involving pediatric patients with SCD.
- Participants engaged in a 6-month Mobile DOT phase, utilizing video self-recording of HU intake, text message reminders, adherence feedback, and incentives.
- HU adherence during the Mobile DOT phase was compared against baseline adherence (6 months pre-intervention) and post-intervention adherence (6 months post-Mobile DOT).
- Medication possession ratio served as the primary outcome measure for HU adherence.
Main Results:
- The clinical trial is currently in progress.
- Preliminary participant feedback indicates high satisfaction with the Mobile DOT intervention.
- Participants reported that daily engagement with Mobile DOT requires less than five minutes.
Conclusions:
- The Mobile DOT strategy shows promise for enhancing HU adherence in pediatric SCD patients.
- Successful implementation of Mobile DOT could lead to improved clinical outcomes for patients with SCD.
- Increased HU adherence through Mobile DOT may contribute to a reduction in healthcare costs associated with SCD management.
Background:
Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). HU can reduce SCD-related complications but only 35% to 50% of pediatric patients adhere to HU at the rates achieved in clinical trials and this limits its clinical effectiveness. Mobile Directly Observed Therapy (Mobile DOT) is a pilot-tested, electronic, multidimensional, HU adherence intervention that targets many components of the Health Behavior Model.
Objective:
The aim of this study is to evaluate the impact of Mobile DOT on HU adherence in children with SCD. The objective of our study is to inform the development of future adherence interventions and pediatric SCD protocols.
Methods:
This is a single-arm crossover study of pediatric patients with SCD. Participants self-record videos of their daily HU administrations and receive text message alerts to take HU, feedback on their HU adherence, and incentives when they achieve adherence goals during the 6-month Mobile DOT phase. Participants' HU adherence during the Mobile DOT phase is compared with their baseline HU adherence (6 months prior to study entry) and to their HU adherence 6 months after completing the Mobile DOT phase. The primary outcome of this study is HU adherence measured by medication possession ratio.
Results:
The trial is ongoing. Preliminary review of participant satisfaction results suggest that most participants can complete Mobile DOT in less than 5 minutes per day and are satisfied with the intervention.
Conclusions:
If effective, the Mobile DOT strategy will increase HU adherence and this could improve patients' clinical outcomes and reduce costs of care.
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