针对1型糖尿病青少年和年轻人的临床基础医疗过渡准备计划：SHIFT随机临床试验的研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-05-27 DOI:10.1016/j.conctc.2025.101500

Laura J. Caccavale , Randi Streisand , Jessica Gokee LaRose , Edmond P. Wickham III , Marisa E. Hilliard , Laura M. Thornton , Melanie K. Bean

{"title":"针对1型糖尿病青少年和年轻人的临床基础医疗过渡准备计划：SHIFT随机临床试验的研究方案","authors":"Laura J. Caccavale , Randi Streisand , Jessica Gokee LaRose , Edmond P. Wickham III , Marisa E. Hilliard , Laura M. Thornton , Melanie K. Bean","doi":"10.1016/j.conctc.2025.101500","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for acute and chronic complications. Identification of evidence-based strategies to enhance T1D management in AYAs, prior to the transition from pediatric to adult healthcare, is needed to optimize AYA health and adequately prepare them for independence. We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation intervention for AYAs with T1D.</div></div><div><h3>Methods</h3><div>Participants will be 50 AYAs with T1D (age 16–22 years) and their parent/caregiver, and 10 pediatric endocrinology practitioners. All practitioners will receive video education about their role in preparing AYAs for transition and strategies for communication with AYAs. Families will be randomized to either: 1) SHIFT, a 6-month multisystem transition preparation program, or 2) enhanced treatment as usual (TAU+). SHIFT includes evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and practitioner communication. Parents in SHIFT receive psychoeducation and training in developmentally-appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. TAU + includes usual care plus patient education matched to the intervention contact schedule. Assessments of hemoglobin A1c, transition readiness, and diabetes self-management behaviors will occur at 0 (baseline), 6 (post; primary endpoint), and 9 and 12 (follow-ups) months.</div></div><div><h3>Conclusion</h3><div>Findings regarding intervention preliminary efficacy will be the foundation of future fully-powered trials on healthcare transition for AYAs with T1D.</div></div><div><h3>Trial registration</h3><div>NCT05639088.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101500"},"PeriodicalIF":1.4000,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial\",\"authors\":\"Laura J. Caccavale , Randi Streisand , Jessica Gokee LaRose , Edmond P. Wickham III , Marisa E. Hilliard , Laura M. Thornton , Melanie K. Bean\",\"doi\":\"10.1016/j.conctc.2025.101500\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for acute and chronic complications. Identification of evidence-based strategies to enhance T1D management in AYAs, prior to the transition from pediatric to adult healthcare, is needed to optimize AYA health and adequately prepare them for independence. We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation intervention for AYAs with T1D.</div></div><div><h3>Methods</h3><div>Participants will be 50 AYAs with T1D (age 16–22 years) and their parent/caregiver, and 10 pediatric endocrinology practitioners. All practitioners will receive video education about their role in preparing AYAs for transition and strategies for communication with AYAs. Families will be randomized to either: 1) SHIFT, a 6-month multisystem transition preparation program, or 2) enhanced treatment as usual (TAU+). SHIFT includes evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and practitioner communication. Parents in SHIFT receive psychoeducation and training in developmentally-appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. TAU + includes usual care plus patient education matched to the intervention contact schedule. Assessments of hemoglobin A1c, transition readiness, and diabetes self-management behaviors will occur at 0 (baseline), 6 (post; primary endpoint), and 9 and 12 (follow-ups) months.</div></div><div><h3>Conclusion</h3><div>Findings regarding intervention preliminary efficacy will be the foundation of future fully-powered trials on healthcare transition for AYAs with T1D.</div></div><div><h3>Trial registration</h3><div>NCT05639088.</div></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"46 \",\"pages\":\"Article 101500\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-05-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865425000742\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000742","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

高达83%的1型糖尿病（T1D）青少年和年轻人（AYA）的血糖结局超出目标范围，使他们面临急性和慢性并发症的风险。在从儿科医疗过渡到成人医疗之前，需要确定以证据为基础的策略来加强AYA的T1D管理，以优化AYA的健康并为他们的独立做好充分准备。我们提出了支持T1D过渡期健康改善（SHIFT）的设计，这是一项随机临床试验，旨在对患有T1D的AYAs进行基于临床的过渡准备干预。研究对象为50名T1D患者（16-22岁）及其父母/照顾者，以及10名儿科内分泌科医生。所有从业人员都将接受视频教育，了解他们在准备AYAs过渡过程中的作用，以及与AYAs沟通的策略。家庭将被随机分配到：1)SHIFT，一个为期6个月的多系统过渡准备项目，或2)照常强化治疗（TAU+）。SHIFT包括3个领域的循证内容：心理教育/技能培养、行为自我管理和从业者沟通。SHIFT的父母接受心理教育和适合发展的养育策略培训，以支持他们的AYA增加独立的自我管理和为过渡做准备。TAU +包括常规护理加上与干预接触时间表相匹配的患者教育。血红蛋白A1c、转换准备和糖尿病自我管理行为的评估将在0（基线）、6（后）和6（后）进行。主要终点)、9个月和12个月（随访）。结论干预措施初步疗效的发现将为未来全面研究AYAs合并T1D的医疗转型奠定基础。registrationNCT05639088审判。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial

Background

A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for acute and chronic complications. Identification of evidence-based strategies to enhance T1D management in AYAs, prior to the transition from pediatric to adult healthcare, is needed to optimize AYA health and adequately prepare them for independence. We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation intervention for AYAs with T1D.

Methods

Participants will be 50 AYAs with T1D (age 16–22 years) and their parent/caregiver, and 10 pediatric endocrinology practitioners. All practitioners will receive video education about their role in preparing AYAs for transition and strategies for communication with AYAs. Families will be randomized to either: 1) SHIFT, a 6-month multisystem transition preparation program, or 2) enhanced treatment as usual (TAU+). SHIFT includes evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and practitioner communication. Parents in SHIFT receive psychoeducation and training in developmentally-appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. TAU + includes usual care plus patient education matched to the intervention contact schedule. Assessments of hemoglobin A1c, transition readiness, and diabetes self-management behaviors will occur at 0 (baseline), 6 (post; primary endpoint), and 9 and 12 (follow-ups) months.

Conclusion

Findings regarding intervention preliminary efficacy will be the foundation of future fully-powered trials on healthcare transition for AYAs with T1D.

Trial registration

NCT05639088.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles 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 a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.