Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Epilepsia. 2021 Jul;62(7):1643-1655. doi: 10.1111/epi.16921. Epub 2021 May 12.
This study was undertaken to examine the efficacy of a family-tailored education and problem-solving behavioral intervention, Supporting Treatment Adherence Regimens (STAR), in young children (2-12 years old) with new onset epilepsy compared to an attention control (i.e., education only [EO]) intervention. Participants randomized to the STAR intervention were hypothesized to demonstrate significantly improved adherence at postintervention and 3-, 6-, and 12-month follow-up visits compared to the EO intervention. Seizure and health-related quality of life (HRQOL) outcomes were also examined.
Two hundred children with new onset epilepsy and their caregivers were recruited during routine epilepsy clinic visits. Baseline questionnaires were completed, and electronic adherence monitors were provided. Participants with adherence less than 95% during the run-in period were randomized to either STAR or EO intervention. Active intervention was provided to both groups for 4 months. Questionnaires were completed at conclusion of the active intervention phase and three follow-up time points (3, 6, and 12 months). Group differences in adherence, seizure outcomes, and HRQOL were examined using regression-based analyses of covariance and longitudinal mixed effect linear or logistical models.
Adherence at 12-month follow-up was significantly different between the STAR (mean = 82.34, SD = 21.29) and EO intervention groups (mean = 61.77, SD = 28.29), with the STAR group demonstrating 20.6% greater adherence (b = 19.11, p = .04, 95% confidence interval = 1.00-37.22, d = .83). No significant differences were found between groups in seizure and HRQOL outcomes.
A family-based behavioral adherence intervention demonstrated sustained adherence improvements 1 year following epilepsy diagnosis compared to an epilepsy-specific education intervention. STAR is an efficacious adherence intervention that can easily be implemented into routine epilepsy care.
本研究旨在探讨针对新诊断癫痫的 2-12 岁儿童，家庭为基础的个体化教育和问题解决行为干预（STAR）与单纯教育（EO）对照的疗效。预期 STAR 组在干预结束后及 3、6、12 个月随访时较 EO 组能显著提高治疗依从性。同时也对癫痫发作和健康相关生活质量（HRQOL）结局进行了评估。
200 名新诊断癫痫儿童及其照顾者在常规癫痫门诊就诊时入组。入组时完成基线问卷调查和电子依从性监测。入组时依从性＜95%的患者被随机分配至 STAR 或 EO 干预组。两组均接受为期 4 个月的主动干预。在主动干预阶段结束时和 3、6、12 个月时完成问卷调查。采用协方差的回归分析和纵向混合效应线性或逻辑回归模型评估两组间在依从性、癫痫发作结局和 HRQOL 方面的差异。
12 个月随访时，STAR 组（平均=82.34，标准差=21.29）和 EO 组（平均=61.77，标准差=28.29）间的依从性存在显著差异，STAR 组依从性提高了 20.6%（b=19.11，p=0.04，95%置信区间为 1.00-37.22，d=0.83）。两组间癫痫发作和 HRQOL 结局无显著差异。
与癫痫专科教育干预相比，家庭为基础的行为依从性干预在癫痫诊断后 1 年仍能持续提高依从性。STAR 是一种有效的依从性干预措施，可轻松纳入常规癫痫护理。
