Janelle L. Wagner , Anup D. Patel , Heather Huszti , Matthew Schmidt , Gigi Smith , Sonal Bhatia , Shanna M. Guilfoyle , Amy Lang , Stacy Buschhaus , Shannon Williams , Jessica Ardo , Marie Davidian , Avani C. Modi
{"title":"eACT 研究的设计和方法：一项针对青少年癫痫患者的新型坚持治疗干预的连续、多重分配、随机试验。","authors":"Janelle L. Wagner , Anup D. Patel , Heather Huszti , Matthew Schmidt , Gigi Smith , Sonal Bhatia , Shanna M. Guilfoyle , Amy Lang , Stacy Buschhaus , Shannon Williams , Jessica Ardo , Marie Davidian , Avani C. Modi","doi":"10.1016/j.cct.2024.107739","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Epilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy.</div></div><div><h3>Methods</h3><div>Using a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline.</div></div><div><h3>Results</h3><div>Of the <em>n</em> = 466 ethnically and racially diverse study participants, <em>n</em> = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life.</div></div><div><h3>Conclusions</h3><div>Novel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Number: <span><span>NCT03817229</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107739"},"PeriodicalIF":2.0000,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy\",\"authors\":\"Janelle L. Wagner , Anup D. Patel , Heather Huszti , Matthew Schmidt , Gigi Smith , Sonal Bhatia , Shanna M. Guilfoyle , Amy Lang , Stacy Buschhaus , Shannon Williams , Jessica Ardo , Marie Davidian , Avani C. Modi\",\"doi\":\"10.1016/j.cct.2024.107739\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Epilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy.</div></div><div><h3>Methods</h3><div>Using a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline.</div></div><div><h3>Results</h3><div>Of the <em>n</em> = 466 ethnically and racially diverse study participants, <em>n</em> = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life.</div></div><div><h3>Conclusions</h3><div>Novel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Number: <span><span>NCT03817229</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"147 \",\"pages\":\"Article 107739\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-11-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424003227\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424003227","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy
Background
Epilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy.
Methods
Using a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline.
Results
Of the n = 466 ethnically and racially diverse study participants, n = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life.
Conclusions
Novel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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