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Improving outcomes in patients with coexisting multimorbid conditions—the development and evaluation of the combined diabetes and renal control trial (C-DIRECT): study protocol
  1. Konstadina Griva1,
  2. Nandakumar Mooppil2,
  3. Eric Khoo3,
  4. Vanessa Yin Woan Lee1,
  5. Augustine Wee Cheng Kang1,
  6. Stanton P Newman4
  1. 1Department of Psychology, National University of Singapore, Singapore
  2. 2National Kidney Foundation Singapore, Singapore
  3. 3Department of Endocrinology, National University Hospital, Singapore
  4. 4City University London, London, UK
  1. Correspondence to Dr Konstadina Griva; psygk{at}nus.edu.sg

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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