PDF(Pubmed)
Abstract：
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.
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).
One hundred four adolescents were recruited (53% female; Mage = 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.
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.
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).
One hundred four adolescents were recruited (53% female; Mage = 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.
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.
摘要：
目标：不坚持抗癫痫药物（ASM）在患有癫痫的青少年中很常见，具有潜在的毁灭性后果。现有的癫痫依从性干预措施无法满足青少年面临的独特挑战。利用社会规范可以利用同伴影响的重要性，同时针对许多青少年的低动机水平。当前的研究检查了可行性，可接受性,以及对青少年癫痫患者的社会规范依从性干预的满意度。
方法：对基线期间表现出非依从（依从≤95%）的患有癫痫的青少年进行了一项m健康社会规范干预试验RCT。青少年被随机分配到(1)个健康社会规范(提醒，个性化和社会规范依从性反馈)或(2)控制(提醒和个性化依从性反馈)。主要结果包括可行性，可接受性,和满意度。探索性结果包括电子监测的依从性，癫痫发作的严重程度，与健康相关的生活质量（HRQOL）。
结果：招募了104名青少年（53％为女性；法师=15.4±1.4岁；81％白人：非西班牙裔；5％黑人，10%Bi/多种族；2%白人：西班牙裔；1%其他：西班牙裔；1%Bi/多种族-西班牙裔）。百分之四十五的屏幕失败是由于高依从性，16%退出，38%被随机分为治疗组(n=19)或对照组(n=21).招聘（75%），保留率（78%），治疗满意度中等高。参与干预是适度的，64%的参与者参与干预通知。探索性分析显示，在控制了COVID-19的影响后，随着时间的推移,与对照组相比,社会规范干预组的依从性较高.注意到两组之间癫痫发作严重程度和HRQOL的小到中等效应大小。
结论：这种试点干预似乎是可行和可接受的。与对照组相比，治疗组的依从性增加幅度不大，但未来需要更大规模更充分的研究来检测效果。值得注意的是,在我们的试验中,似乎COVID大流行影响了依从行为.
方法：对基线期间表现出非依从（依从≤95%）的患有癫痫的青少年进行了一项m健康社会规范干预试验RCT。青少年被随机分配到(1)个健康社会规范(提醒，个性化和社会规范依从性反馈)或(2)控制(提醒和个性化依从性反馈)。主要结果包括可行性，可接受性,和满意度。探索性结果包括电子监测的依从性，癫痫发作的严重程度，与健康相关的生活质量（HRQOL）。
结果：招募了104名青少年（53％为女性；法师=15.4±1.4岁；81％白人：非西班牙裔；5％黑人，10%Bi/多种族；2%白人：西班牙裔；1%其他：西班牙裔；1%Bi/多种族-西班牙裔）。百分之四十五的屏幕失败是由于高依从性，16%退出，38%被随机分为治疗组(n=19)或对照组(n=21).招聘（75%），保留率（78%），治疗满意度中等高。参与干预是适度的，64%的参与者参与干预通知。探索性分析显示，在控制了COVID-19的影响后，随着时间的推移,与对照组相比,社会规范干预组的依从性较高.注意到两组之间癫痫发作严重程度和HRQOL的小到中等效应大小。
结论：这种试点干预似乎是可行和可接受的。与对照组相比，治疗组的依从性增加幅度不大，但未来需要更大规模更充分的研究来检测效果。值得注意的是,在我们的试验中,似乎COVID大流行影响了依从行为.
