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The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence
Janelle L Wagner1, Anup D Patel2, Heather Huszti3
1College of Nursing, Medical University of South Carolina, Charleston, SC, USA.
Contemporary Clinical Trials
|November 12, 2024
Summary
This study tested a behavioral intervention to improve anti-seizure medication adherence in children with epilepsy. The sequential, multiple assignment, randomized trial (SMART) design aimed to enhance medication adherence and health outcomes.
Area of Science:
- Pediatric Neurology
- Behavioral Health Interventions
- Clinical Trial Design
Background:
- Epilepsy is a common chronic pediatric neurological condition.
- Anti-seizure medications (ASMs) are the primary treatment, but adherence is a challenge for ~60% of youth.
- This study focuses on improving ASM adherence in young children with epilepsy.
Purpose of the Study:
- To test the effectiveness of a behavioral health intervention to improve anti-seizure medication (ASM) adherence in families of young children with epilepsy.
- To evaluate the impact of the intervention on seizure freedom, healthcare utilization, and quality of life.
- To describe the methodology, recruitment, and baseline characteristics of a sequential, multiple assignment, randomized trial (SMART).
Main Methods:
- A two-stage SMART design enrolled 466 ethnically and racially diverse youth (ages 2-12) with newly diagnosed epilepsy.
- Following an 8-week run-in, 268 non-adherent families were randomized to control (education + digital reminders) or intervention (education + digital reminders + individualized feedback).
- Non-adherent families in the intervention group were re-randomized to continue the intervention or receive telehealth problem-solving sessions.
Main Results:
- The primary outcome was electronically monitored ASM adherence.
- Secondary outcomes included seizure freedom, healthcare utilization, and epilepsy-specific health-related quality of life.
- Study measures were collected at baseline and 8, 14, and 20 months post-baseline.
Conclusions:
- The study employed novel trial design aspects, including sequential randomization and recruitment of diverse youth.
- Modifications were made due to the COVID-19 pandemic and evolving socio-political and medical climate.
- Recruitment and retention challenges were encountered and are discussed.
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