This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.
Keywords: Behavioral treatment; Compliance; Enrichment design; Pediatric; Randomized controlled clinical trial; Seizures.
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A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.Epilepsia. 2016 Mar;57(3):e69-75. doi: 10.1111/epi.13289. Epub 2015 Dec 23. Epilepsia. 2016. PMID: 26693964 Free PMC article. Clinical Trial.
Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.Health Technol Assess. 2014 Mar;18(20):1-202. doi: 10.3310/hta18200. Health Technol Assess. 2014. PMID: 24690402 Free PMC article. Clinical Trial.
Self-Management education for adults with poorly controlled epILEpsy [SMILE (UK)]: a randomised controlled trial.Health Technol Assess. 2018 Apr;22(21):1-142. doi: 10.3310/hta22210. Health Technol Assess. 2018. PMID: 29717699 Free PMC article. Clinical Trial.
Can an epilepsy nurse specialist-led self-management intervention reduce attendance at emergency departments and promote well-being for people with severe epilepsy? A non-randomised trial with a nested qualitative phase.Southampton (UK): NIHR Journals Library; 2013 Oct. NIHR Journals Library. 2013. PMID: 25642529 Free Books & Documents. Review.
Treatments for seizures in catamenial (menstrual-related) epilepsy.Cochrane Database Syst Rev. 2019 Oct 14;10(10):CD013225. doi: 10.1002/14651858.CD013225.pub2. Online ahead of print. Cochrane Database Syst Rev. 2019. PMID: 31608992 Review.