Griva Konstadina, Mooppil Nandakumar, Khoo Eric, Lee Vanessa Yin Woan, Kang Augustine Wee Cheng, Newman Stanton P
Department of Psychology, National University of Singapore, Singapore.
National Kidney Foundation Singapore, Singapore.
BMJ Open. 2015 Feb 12;5(2):e007253. doi: 10.1136/bmjopen-2014-007253.
Diabetes mellitus (DM) is the most common cause of end-stage renal disease (ESRD). Patients with diabetes on dialysis have worse clinical outcomes and increased psychological burden. The need to manage the combined treatment demands for both conditions is particularly challenging yet there is paucity of data of the barriers preventing optimal management to combined therapy for diabetes and kidney failure. The study aims to explore needs of patients and develop an intervention to enable people with diabetes and ESRD to better manage both their conditions.
A two-phase study comprising a mixed method observational study (phase I) and a feasibility trial (phase II). Phase I will seek to document outcomes and needs of the population (patients with DM-ESRD) and seek input on preferred delivery/implementation for the programme. Data will be collected with in-depth interviews with patients, caregivers and healthcare providers (N=50), and from a questionnaire-based survey (N=170). Phase 2 will build on these data to design and test the feasibility of a practical, low-intensity, clinic-integrated intervention using a self-management paradigm. The intervention will primarily seek to support behavioural change so as to improve adherence and clinical outcomes for DM as well as for ESRD. For the feasibility trial, we will be evaluating acceptability, retention and completion rates of the programme.
The study protocol has been approved by the local ethics committee and written informed consent is required from every participant. Findings will be disseminated through journals, conferences and will be used to create a fully manualised intervention (materials) and training course for facilitators.
糖尿病（DM）是终末期肾病（ESRD）最常见的病因。接受透析的糖尿病患者临床结局较差，心理负担加重。同时管理这两种疾病的联合治疗需求极具挑战性，但目前缺乏关于阻碍糖尿病和肾衰竭联合治疗优化管理的障碍的数据。本研究旨在探索患者需求，并开发一种干预措施，使糖尿病和ESRD患者能够更好地管理这两种疾病。
一项分为两个阶段的研究，包括混合方法观察性研究（第一阶段）和可行性试验（第二阶段）。第一阶段将记录该人群（糖尿病-ESRD患者）的结局和需求，并就该项目的首选实施方式征求意见。将通过对患者、护理人员和医疗服务提供者进行深入访谈（N = 50）以及基于问卷的调查（N = 170）来收集数据。第二阶段将基于这些数据，设计并测试一种基于自我管理模式的实用、低强度、整合到诊所的干预措施的可行性。该干预措施主要旨在支持行为改变，以提高糖尿病和ESRD的依从性及临床结局。对于可行性试验，我们将评估该项目的可接受性、保留率和完成率。
本研究方案已获得当地伦理委员会的批准，每位参与者均需签署书面知情同意书。研究结果将通过期刊、会议进行传播，并将用于创建一份完整的干预手册（材料）以及为实施者提供培训课程。
