青少年癫痫患者依从性社会规范干预的初步随机对照临床试验。
Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy.
机构信息
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 3333 Burnet Ave., Cincinnati, OH 45229, United States; University of Cincinnati, College of Medicine, Cincinnati, OH, United States.
Nationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States; The Ohio State, Department of Pediatrics, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States.
出版信息
Epilepsy Behav. 2023 Mar;140:109082. doi: 10.1016/j.yebeh.2022.109082. Epub 2023 Jan 31.
OBJECTIVE
Non-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The current study examined the feasibility, acceptability, and satisfaction of a social norms adherence intervention in adolescents with epilepsy.
METHODS
A pilot RCT of a mHealth social norms intervention was conducted with adolescents with epilepsy who demonstrated non-adherence (≤95% adherence) during baseline. Adolescents were randomized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adherence, seizure severity, and health-related quality of life (HRQOL).
RESULTS
One hundred four adolescents were recruited (53% female; M = 15.4 ± 1.4 years; 81% White: Non-Hispanic; 5% Black, 10% Bi/Multiracial; 2% White: Hispanic; 1% Other: Hispanic; 1% Bi/Multiracial-Hispanic). Forty-five percent screen-failed due to high adherence, 16% withdrew, and 38% were randomized to treatment (n = 19) or control (n = 21). Recruitment (75%), retention (78%), and treatment satisfaction were moderately high. Engagement with the intervention was moderate, with 64% of participants engaging with intervention notifications. Exploratory analyses revealed that after controlling for COVID-19 impact, the social norms intervention group maintained higher adherence over time compared to the control group. Small to moderate effect sizes were noted for seizure severity and HRQOL between groups.
CONCLUSION
This pilot intervention appeared feasible and acceptable. Increases in adherence in the treatment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.
目的
青少年癫痫患者抗癫痫药物（ASMs）依从性差，可能产生灾难性后果。现有的癫痫依从性干预措施并不能满足青少年所面临的独特挑战。利用社会规范可以利用同伴影响的重要性增加，同时针对许多青少年的低动力水平。本研究探讨了一种基于移动医疗（mHealth）的社会规范依从性干预措施在青少年癫痫患者中的可行性、可接受性和满意度。
方法
对基线时表现出不依从（依从率≤95%）的青少年癫痫患者进行 mHealth 社会规范干预的试点随机对照试验。青少年被随机分配到 mHealth 社会规范组（提醒、个体化和社会规范依从反馈）或对照组（提醒和个体化依从反馈）。主要结局包括可行性、可接受性和满意度。探索性结局包括电子监测的依从性、癫痫发作严重程度和健康相关生活质量（HRQOL）。
结果
共招募了 104 名青少年（53%为女性；M=15.4±1.4 岁；81%为白人：非西班牙裔；5%为黑人，10%为混血/多种族；2%为白人：西班牙裔；1%为其他：西班牙裔；1%为混血/多种族-西班牙裔）。由于高依从率，45%的青少年筛检失败，16%的青少年退出，38%的青少年被随机分配到治疗组（n=19）或对照组（n=21）。招募率（75%）、保留率（78%）和治疗满意度均较高。干预的参与度中等，有 64%的参与者参与了干预通知。探索性分析显示，在控制 COVID-19 影响后，社会规范干预组的依从性随着时间的推移保持较高水平，与对照组相比。组间癫痫发作严重程度和 HRQOL 存在小到中等效应量。
结论
该试点干预措施似乎可行且可接受。治疗组与对照组相比，依从性略有增加，但需要进行更大规模、更充分的随机对照试验来检测效果。值得注意的是，在我们的试验期间，COVID 大流行似乎影响了依从行为。
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