Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, 3rd Floor Burnett Building The Alfred Hospital, Melbourne 3004, Australia.
BMC Public Health. 2010 Oct 12;10:599. doi: 10.1186/1471-2458-10-599.
An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours.
METHODS/DESIGN: A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned.
Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore, the study will provide insight into the potential for more widespread uptake of automated telehealth interventions, globally.
ACTRN12607000594426.
据估计，全球有 2.85 亿人患有糖尿病，预计到 2030 年，这一数字将增至 4.39 亿。据估计，2010 年全球 20-79 岁人群中有 396 万人的死亡可归因于糖尿病。自我管理被认为是糖尿病护理的一个组成部分。本文描述了一项随机对照试验的方案，该试验采用自动化互动电话系统，旨在提高基本糖尿病自我管理行为的采用和维持率。
方法/设计：共有 340 名 2 型糖尿病患者将被随机分配到常规护理组或干预组，干预组除接受常规护理外，还接受电话连接护理（TLC）糖尿病计划。该干预要求参与者每周通过 TLC 糖尿病电话系统通话 6 个月。他们会收到研究手册和一个血糖仪，血糖仪与数据上传设备相连。TLC 系统由一台计算机和软件组成，旨在根据当前或之前通话中提出或输入的答案，提供糖尿病自我管理关键方面的监测、个性化反馈和教育。数据收集在基线（时间 1）、6 个月随访（时间 2）和 12 个月随访（时间 3）进行。主要结局指标为血糖控制（HbA1c）和生活质量（健康调查短表 36 版 2）。次要结局指标包括人体测量指标、血压、血脂谱、心理社会指标以及饮食、身体活动、血糖监测、足部护理和药物使用的测量。还收集了关于医疗服务利用情况的信息，包括住院、药物使用和费用。还计划进行经济评估。
结果将提供有关电话连接护理干预措施对糖尿病自我管理的疗效的证据。此外，该研究将深入了解在全球范围内更广泛采用自动化远程医疗干预措施的潜力。
ACTRN12607000594426。
