The combined diabetes and renal control trial (C-DIRECT) - a feasibility randomised controlled trial to evaluate outcomes in multi-morbid patients with diabetes and on dialysis using a mixed methods approach

K Griva,Y T D Choong,M Rajeswari,Z S Goh,E Y H Khoo,C G Chua,S P Newman,V Y W Lee,M Nandakumar

doi:10.1186/s12882-018-1183-z

Abstract

BackgroundThis cluster randomised controlled trial set out to investigate the feasibility and acceptability of the “Combined Diabetes and Renal Control Trial” (C-DIRECT) intervention, a nurse-led intervention based on motivational interviewing and self-management in patients with coexisting end stage renal diseases and diabetes mellitus (DM ESRD). Its efficacy to improve glycaemic control, as well as psychosocial and self-care outcomes were also evaluated as secondary outcomes.MethodsAn assessor-blinded, clustered randomised-controlled trial was conducted with 44 haemodialysis patients with DM ESRD and ≥ 8% glycated haemoglobin (HbA1c), in dialysis centres across Singapore. Patients were randomised according to dialysis shifts. 20 patients were assigned to intervention and 24 were in usual care. The C-DIRECT intervention consisted of three weekly chair-side sessions delivered by diabetes specialist nurses. Data on recruitment, randomisation, and retention, and secondary outcomes such as clinical endpoints, emotional distress, adherence, and self-management skills measures were obtained at baseline and at 12 weeks follow-up. A qualitative evaluation using interviews was conducted at the end of the trial.ResultsOf the 44 recruited at baseline, 42 patients were evaluated at follow-up. One patient died, and one discontinued the study due to deteriorating health. Recruitment, retention, and acceptability rates of C-DIRECT were generally satisfactory HbA1c levels decreased in both groups, but C-DIRECT had more participants with HbA1c < 8% at follow up compared to usual care. Significant improvements in role limitations due to physical health were noted for C-DIRECT whereas levels remained stable in usual care. No statistically significant differences between groups were observed for other clinical markers and other patient-reported outcomes. There were no adverse effects.ConclusionsThe trial demonstrated satisfactory feasibility. A brief intervention delivered on bedside as part of routine dialysis care showed some benefits in glycaemic control and on QOL domain compared with usual care, although no effect was observed in other secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients.Trial registration numberTrial registered with the International Standard Randomised Controlled Trial (ISRCTN10546597). Registered 12 September 2016 (Retrospectively registered).

Highlights

This cluster randomised controlled trial set out to investigate the feasibility and acceptability of the “Combined Diabetes and Renal Control Trial” (C-DIRECT) intervention, a nurse-led intervention based on motivational interviewing and self-management in patients with coexisting end stage renal diseases and diabetes mellitus (DM End-stage Renal Disease (ESRD))
A brief intervention delivered on bedside as part of routine dialysis care showed some benefits in glycaemic control and on Quality of life (QOL) domain compared with usual care, no effect was observed in other secondary outcomes
A self-management program (HEDSMART) developed for patients on haemodialysis (HD) has shown improved clinical and behavioural outcomes and reductions in depression [21, 22], but proportion of patients with diabetes recruited was low. Leveraging on this approach and following formative work with Diabetes Mellitus (DM) ESRD patients [23], we have developed a brief-clinic integrated intervention for patients with coexisting DM and ESRD currently treated with HD, the “Combined Diabetes and Renal Control Trial” (C-DIRECT) to support self-management for both conditions

Summary

Introduction

This cluster randomised controlled trial set out to investigate the feasibility and acceptability of the “Combined Diabetes and Renal Control Trial” (C-DIRECT) intervention, a nurse-led intervention based on motivational interviewing and self-management in patients with coexisting end stage renal diseases and diabetes mellitus (DM ESRD). Improved self-management has been identified as key in improving disease outcomes and quality of life for people with long-term conditions and relevant interventions have the potential to yield benefits for patients and health care systems alike [1]. Comorbid diabetes mellitus and end-stage renal disease (DM ESRD) is a major and emerging condition that health care services must manage. Diabetic nephropathy is the leading cause of ESRD, with as many as 50% of patients on renal replacement therapy being diagnosed with DM ESRD [2, 3]. Diet is challenging for DM ESRD patients as they have to abide to often complex and incompatible dietary recommendations leading to a suboptimal self-care and management [13].

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