title: Improving outcomes in patients with coexisting multimorbid conditions-the development and evaluation of the combined diabetes and renal control trial (C-DIRECT): study protocol.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
authors: Department of Psychology, National University of Singapore, Singapore.
authors: Konstadina
authors: K
authors: Griva
authors: National Kidney Foundation Singapore, Singapore.
authors: Nandakumar
authors: N
authors: Mooppil
authors: Department of Endocrinology, National University Hospital, Singapore.
authors: Eric
authors: E
authors: Khoo
authors: Department of Psychology, National University of Singapore, Singapore.
authors: Vanessa Yin Woan
authors: VY
authors: Lee
authors: Department of Psychology, National University of Singapore, Singapore.
authors: Augustine Wee Cheng
authors: AW
authors: Kang
authors: City University London, London, UK.
authors: Stanton P
authors: SP
authors: Newman
mesh_terms: D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000628:therapy*; D019468:Disease Management; D005260:Female; D015438:Health Behavior; D006282:Health Personnel; D006301:Health Services Needs and Demand; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D010349:Patient Compliance; D006435:Renal Dialysis; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D016896:Treatment Outcome