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一项针对成年残疾人和2型糖尿病患者的技术强化医学营养治疗与糖尿病自我管理教育:一项试点及可行性随机对照试验方案

A Technology-Enhanced Medical Nutrition Therapy and Diabetes Self-Management Education for Adults With Disability and Type 2 Diabetes: Protocol for a Pilot and Feasibility Randomized Controlled Trial.

作者信息

Aboagye Anita, Peckham Jessica, Hearld Kristine Ria, Abdullah Shireen, Thirumalai Mohanraj

机构信息

Department of Community Health and Human Services, School of Education and Human Sciences, University of Alabama at Birmingham, Birmingham, AL, United States.

Kamin Consulting Inc, Texas, TX, United States.

出版信息

JMIR Res Protoc. 2025 Sep 26;14:e71495. doi: 10.2196/71495.

Abstract

BACKGROUND

Diabetes mellitus (DM) is a serious chronic disorder that affects many individuals globally, particularly persons with disabilities, and has long-term adverse effects on the health of individuals and society. Effective self-management education is therefore required. Diabetes management focused on medical nutrition therapy (MNT) and diabetes self-management education (DSME) combined with telehealth technology has the potential to increase the active performance of diabetes management behaviors among persons with disabilities and improve their overall quality of life and quality of self-care.

OBJECTIVE

This study aims to evaluate the impact of different levels of technology on the delivery of MNT and DSME among persons with disabilities.

METHODS

The study is a single-blinded, 3-arm, randomized controlled trial among adults living with both type 2 diabetes and a permanent physical disability. Web-based recruitment is done through partner organizations. The target sample size is 90 participants randomized into 3 arms: a high-technology, a low-technology, and an attention control arm. The high-technology arm receives diabetes-related materials weekly through mediums such as email, a telehealth platform, and text; the low-technology arm receives only 1 weekly email with diabetes-related material; and the attention control arm has no technology support. The intervention is provided by a certified diabetes care and education specialist. Using multivariate linear mixed models, the study examines the relationships between the level of technology intervention and DM self-management behaviors, self-efficacy, and reductions in glycated hemoglobin (HbA). The primary outcome is the proportion of participants in each group with improved self-management behaviors, as measured by several validated questionnaires. The secondary outcome is a better HbA reduction. Outcomes are measured at baseline and at 6 months. Questionnaires and HbA measures will be used to measure outcomes.

RESULTS

Data collection began in June 2024 with a total of 90 recruited participants. The intervention was delivered. Make-up classes were delivered to participants in any of the 3 cohorts between November 2024 and December 2024. The final 3-month follow-up classes were held for each cohort 3 months after the first class. Data analysis is anticipated to be completed in fall 2025.

CONCLUSIONS

Effective self-management in DM is important to reduce complications. Using technology to deliver MNT and DSME could serve as an effective and convenient strategy for providing these interventions. However, intervention studies are required to determine the most effective level of technology for delivering MNT and DSME intervention to this target group. The YumABLE study is expected to provide new, meaningful, and detailed information about the effectiveness of technology and telehealth platforms for effectively delivering an MNT and DSME program for people living with a permanent physical disability and type 2 diabetes. The results will further improve web- and technology-based diabetes self-management interventions for people with disabilities.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06049225; https://clinicaltrials.gov/study/NCT06049225.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71495.

摘要

背景

糖尿病(DM)是一种严重的慢性疾病,全球影响着许多人,尤其是残疾人,对个人和社会健康具有长期不良影响。因此,需要有效的自我管理教育。以医学营养治疗(MNT)和糖尿病自我管理教育(DSME)为重点,并结合远程医疗技术的糖尿病管理,有可能提高残疾人糖尿病管理行为的积极表现,改善他们的整体生活质量和自我护理质量。

目的

本研究旨在评估不同技术水平对残疾人群体中MNT和DSME提供的影响。

方法

该研究是一项针对同时患有2型糖尿病和永久性身体残疾的成年人的单盲、三臂、随机对照试验。通过合作组织进行基于网络的招募。目标样本量为90名参与者,随机分为三组:高科技组、低技术组和注意力控制组。高科技组每周通过电子邮件、远程医疗平台和短信等媒介接收糖尿病相关材料;低技术组每周仅接收一封包含糖尿病相关材料的电子邮件;注意力控制组没有技术支持。干预由认证的糖尿病护理和教育专家提供。该研究使用多元线性混合模型,考察技术干预水平与糖尿病自我管理行为、自我效能以及糖化血红蛋白(HbA)降低之间的关系。主要结局是通过几份经过验证的问卷测量的每组中自我管理行为得到改善的参与者比例。次要结局是更好地降低HbA。在基线和6个月时测量结局。将使用问卷和HbA测量来评估结局。

结果

数据收集于2024年6月开始,共招募了90名参与者。进行了干预。在2024年11月至2024年12月期间,为三个队列中的任何一个队列的参与者提供了补课。在第一堂课3个月后,为每个队列举行了最后的3个月随访课。预计数据分析将于2025年秋季完成。

结论

糖尿病的有效自我管理对于减少并发症很重要。利用技术提供MNT和DSME可以作为提供这些干预措施的有效且便捷的策略。然而,需要进行干预研究来确定为该目标群体提供MNT和DSME干预的最有效技术水平。YumABLE研究预计将提供有关技术和远程医疗平台有效性的新的、有意义的详细信息,以便为患有永久性身体残疾和2型糖尿病的人有效提供MNT和DSME项目。研究结果将进一步改善针对残疾人的基于网络和技术的糖尿病自我管理干预措施。

试验注册

ClinicalTrials.gov NCT06049225;https://clinicaltrials.gov/study/NCT06049225。

国际注册报告标识符(IRRID):DERR1-10.2196/71495。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bbf/12514415/0ccad13d6208/resprot_v14i1e71495_fig1.jpg

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