Self-Management for Youth Living with Sickle Cell Disease (SMYLS): A study protocol for a multisite randomized controlled trial testing a behavioral, mHealth app

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-10-04 DOI:10.1016/j.cct.2025.108103

Shannon Phillips , Kaila Martin , Alyssa M. Schlenz , Julie Kanter , Martina Mueller , Jeffery Lebensburger , Najibah Galandanci , Beng R. Fuh , Chelsea Rivenbark , Ofelia A. Alvarez , Rochelle F. Hanson , Mohan Madisetti , Margaret Prentice , Teresa J. Kelechi

{"title":"Self-Management for Youth Living with Sickle Cell Disease (SMYLS): A study protocol for a multisite randomized controlled trial testing a behavioral, mHealth app","authors":"Shannon Phillips , Kaila Martin , Alyssa M. Schlenz , Julie Kanter , Martina Mueller , Jeffery Lebensburger , Najibah Galandanci , Beng R. Fuh , Chelsea Rivenbark , Ofelia A. Alvarez , Rochelle F. Hanson , Mohan Madisetti , Margaret Prentice , Teresa J. Kelechi","doi":"10.1016/j.cct.2025.108103","DOIUrl":null,"url":null,"abstract":"<div><div>Adolescents and young adults (AYA) with sickle cell disease (SCD) encounter adverse health events during transition to adult care. While AYA with SCD face complex barriers to care, negative outcomes can be mitigated by the development of self-management behaviors. Self-Management for Youth Living with Sickle Cell Disease (SMYLS) is an application designed to improve SCD specific self-management, with promising results from feasibility studies. This paper describes the next stage of SMYLS, a multisite, hybrid type 1 effectiveness-implementation randomized controlled trial. Trial aims are to evaluate the effectiveness of the mHealth application, including the role of patient activation; assess potential for wide-scale implementation; and explore the impact of socioenvironmental and psychosocial factors on outcomes. There will be 272 AYA with SCD and their caregivers enrolled and randomized to control or intervention arm (1:1) after assessing activation level. The intervention arm will receive usual care and be encouraged to use the application daily for an initial intervention period and a later “booster” period, while the control arm will receive usual care plus a version of the application with SCD educational materials. Study aims will be evaluated using mixed methods (participant surveys at 1, 3, 6, 9, and 12 months and interviews with participants and providers/clinic administrators post-intervention). The SMYLS intervention has the potential to inform widescale adoption of a self-management intervention for AYA with SCD. The results may have broader applicability for conducting trials among youth with chronic illnesses facing similar barriers to care and for studying engagement in mHealth self-management interventions.</div><div><strong>Clinical trial registration number.</strong></div><div><span><span>NCT06035939</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108103"},"PeriodicalIF":1.9000,"publicationDate":"2025-10-04","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/S1551714425002976","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Adolescents and young adults (AYA) with sickle cell disease (SCD) encounter adverse health events during transition to adult care. While AYA with SCD face complex barriers to care, negative outcomes can be mitigated by the development of self-management behaviors. Self-Management for Youth Living with Sickle Cell Disease (SMYLS) is an application designed to improve SCD specific self-management, with promising results from feasibility studies. This paper describes the next stage of SMYLS, a multisite, hybrid type 1 effectiveness-implementation randomized controlled trial. Trial aims are to evaluate the effectiveness of the mHealth application, including the role of patient activation; assess potential for wide-scale implementation; and explore the impact of socioenvironmental and psychosocial factors on outcomes. There will be 272 AYA with SCD and their caregivers enrolled and randomized to control or intervention arm (1:1) after assessing activation level. The intervention arm will receive usual care and be encouraged to use the application daily for an initial intervention period and a later “booster” period, while the control arm will receive usual care plus a version of the application with SCD educational materials. Study aims will be evaluated using mixed methods (participant surveys at 1, 3, 6, 9, and 12 months and interviews with participants and providers/clinic administrators post-intervention). The SMYLS intervention has the potential to inform widescale adoption of a self-management intervention for AYA with SCD. The results may have broader applicability for conducting trials among youth with chronic illnesses facing similar barriers to care and for studying engagement in mHealth self-management interventions.

Clinical trial registration number.

NCT06035939

查看原文本刊更多论文

镰状细胞病患者自我管理（SMYLS）：一项多地点随机对照试验的研究方案，测试一种行为移动健康应用程序。

患有镰状细胞病（SCD）的青少年和年轻人（AYA）在向成人护理过渡期间会遇到不良健康事件。虽然患有SCD的AYA面临复杂的护理障碍，但通过自我管理行为的发展可以减轻负面结果。青年镰状细胞病患者自我管理（SMYLS）是一个旨在改善镰状细胞病患者自我管理的应用程序，可行性研究结果令人鼓舞。本文描述了SMYLS的下一阶段，这是一项多站点，混合1型有效性实施随机对照试验。试验的目的是评估移动医疗应用的有效性，包括患者激活的作用；评估大规模实施的潜力；并探讨社会环境和社会心理因素对结果的影响。在评估激活水平后，将有272名患有SCD的AYA及其护理人员入组，并随机分为对照组或干预组（1:1）。干预组将接受常规护理，并被鼓励在最初的干预期和随后的“加强”期每天使用该应用程序，而对照组将接受常规护理，并获得一份带有SCD教育材料的应用程序版本。研究目的将使用混合方法进行评估（在1、3、6、9和12 个月时对参与者进行调查，并在干预后对参与者和提供者/诊所管理人员进行访谈）。SMYLS干预措施有可能为患有SCD的AYA患者广泛采用自我管理干预措施提供信息。这些结果可能具有更广泛的适用性，可以在患有慢性病的年轻人中进行试验，这些年轻人面临着类似的护理障碍，也可以研究移动医疗自我管理干预措施的参与情况。临床试验注册号。NCT06035939。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

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.