EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-08-30 DOI:10.1016/j.cct.2024.107673

Jashalynn German , Qing Yang , Daniel Hatch , Allison Lewinski , Hayden B. Bosworth , Brystana G. Kaufman , Ranee Chatterjee , Gina Pennington , Doreen Matters , Donghwan Lee , Diana Urlichich , Sarah Kokosa , Holly Canupp , Patrick Gregory , Cindy Leslie Roberson , Benjamin Smith , Sherry Huber , Katheryn Doukellis , Tammi Deal , Rose Burns , Ryan J. Shaw

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引用次数: 0

Abstract

Background

Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.

Methods

Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.

Results

Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.

Conclusion

The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.

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由护士提供的慢性病护理扩展技术（EXTEND）：随机试验的协议和基线数据。

背景：约有 10-15% 的 2 型糖尿病患者尽管接受了治疗，但糖尿病（PPDM）仍持续控制不佳，而且经常合并高血压。通过支持自我管理和促进患者与医生的联系，支持移动监测的远程医疗有可能改善耐药性慢性疾病的治疗效果，但必须以适合现实世界使用的方式进行设计：扩展技术支持、护士提供的慢性病护理（EXTEND）是一项正在进行的随机试验，该试验比较了两种为期12个月的干预措施，以治疗合并症PPDM和高血压：1）EXTEND，一种支持移动监测的自我管理干预措施；2）EXTEND Plus，一种综合的、由护士提供的远程医疗计划，其中包含移动监测、自我管理支持和药剂师支持的药物管理。两个项目都利用了一个新颖的平台，该平台利用现有的技术基础设施将患者生成的健康数据传输到电子健康记录中。主要研究结果是 HbA1c 从基线到 12 个月的变化差异。次要结果包括血压、体重、实施障碍/促进因素和成本：在对 220 名患者进行随机分组后，研究于 2023 年 6 月结束。两组患者的基线特征相似；平均年龄为 54.5 岁，队列中主要为女性（63.6%）和黑人（68.2%），基线 HbA1c 为 9.81%：EXTEND 试验正在评估两种支持移动监测的远程医疗方法，旨在改善 PPDM 和高血压患者的治疗效果。重要的是，这些方法都是围绕现有的基础设施设计的，因此易于实施和推广。这项研究将促进远程医疗在现实世界中的应用，为高危慢性病患者带来最大益处。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.