1型糖尿病与生命（T1DAL）试点和可行性研究的设计：针对临床环境中与健康相关的生活质量的简短远程医疗干预

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-05-13 DOI:10.1016/j.conctc.2025.101491

Marisa E. Hilliard , Wendy Levy , Ruth S. Weinstock , Korey K. Hood , Paula M. Trief , Daniel J. DeSalvo , Yuliana Rojas , Kyrah Holland , Aika K. Schneider-Utaka , Selma A. Alamarie , Lynn Agostini , Se-Kang Kim , Maartje de Wit , Meghan E. McGrady , Laurel H. Messer , Barbara J. Anderson

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引用次数: 0

摘要

1型糖尿病（T1D）的管理要求很高，并且会影响糖尿病患者（pwd）及其家庭成员的生活质量。行为干预研究主要集中在青少年，以前的干预措施对生活质量有好处，但在常规护理中实施的潜力有限。该试验正在试点一项针对健康相关生活质量（HRQOL）的简短行为干预，该干预可在一系列临床护理环境中对所有年龄的残疾患者实施。目的是(1)评估干预的可行性和可接受性，(2)探索干预前后心理社会和临床结果的变化，以及(3)探索与干预开发和实施相关的成本。方法研究对象为在儿科亚专科、成人专科和初级保健机构接受T1D治疗的所有年龄的PWD患者（目标n = 120,40 /站点），以及父母（儿童）或伴侣（成人）。经过认证的糖尿病护理和教育专家在6个月内进行两次~ 30-45分钟的远程治疗。在治疗过程中，干预师会回顾参与者在治疗前对特定于t1d的HRQOL的反应所产生的“生活质量概况”，并根据他们的个人优势和挑战提供行为策略和资源。可行性和可接受性数据包括招聘/入学/保留率、干预保真度、满意度调查和定性访谈。在基线和6个月收集心理社会和临床结果的前后测量。本试点研究将产生针对青少年和成年残疾人及其家庭成员的HRQOL的简短干预的初步数据，该干预旨在在一系列护理环境中实施。

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Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings

Background

Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited potential for implementation in routine care. This trial is piloting a brief behavioral intervention that targets health-related quality of life (HRQOL), which can be implemented with PWDs of all ages in a range of clinical care settings. The aims are to (1) evaluate intervention feasibility and acceptability, (2) explore pre-post change in psychosocial and clinical outcomes, and (3) explore costs related to intervention development and implementation.

Methods

Participants are PWD of all ages who receive T1D care in pediatric subspecialty, adult specialty, and primary care settings (target n = 120, 40/site) and a parent (for children) or partner (for adults). Certified diabetes care and education specialists deliver the intervention during two ∼30-45-min remote sessions over 6 months. In the sessions, interventionists review a “quality of life profile” generated from participants’ pre-session responses to a measure of T1D-specific HRQOL, and provide behavioral strategies and resources tailored to their individual strengths and challenges. Feasibility and acceptability data include recruitment/enrollment/retention rates, intervention fidelity, satisfaction surveys, and qualitative interviews. Pre-post measures of psychosocial and clinical outcomes are collected at baseline and 6 months.

Conclusion

This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members, designed for implementation across a range of care settings.

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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.