Elsevier

The Lancet

Volume 371, Issue 9626, 24–30 May 2008, Pages 1769-1776
The Lancet

Articles
Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial

https://doi.org/10.1016/S0140-6736(08)60764-3Get rights and content

Summary

Background

Delivery of high-quality, evidence-based health care to deprived sectors of the community is a major goal for society. We investigated the effectiveness of a culturally sensitive, enhanced care package in UK general practices for improvement of cardiovascular risk factors in patients of south Asian origin with type 2 diabetes.

Methods

In this cluster randomised controlled trial, 21 inner-city practices in the UK were assigned by simple randomisation to intervention (enhanced care including additional time with practice nurse and support from a link worker and diabetes-specialist nurse [nine practices; n=868]) or control (standard care [12 practices; n=618]) groups. All adult patients of south Asian origin with type 2 diabetes were eligible. Prescribing algorithms with clearly defined targets were provided for all practices. Primary outcomes were changes in blood pressure, total cholesterol, and glycaemic control (haemoglobin A1c) after 2 years. Analysis was by intention to treat. This trial is registered, number ISRCTN 38297969.

Findings

We recorded significant differences between treatment groups in diastolic blood pressure (1·91 [95% CI −2·88 to −0·94] mm Hg, p=0·0001) and mean arterial pressure (1·36 [−2·49 to −0·23] mm Hg, p=0·0180), after adjustment for confounders and clustering. We noted no significant differences between groups for total cholesterol (0·03 [−0·04 to 0·11] mmol/L), systolic blood pressure (−0·33 [−2·41 to 1·75] mm Hg), or HbA1c (−0·15% [−0·33 to 0·03]). Economic analysis suggests that the nurse-led intervention was not cost effective (incremental cost-effectiveness ratio £28 933 per QALY gained). Across the whole study population over the 2 years of the trial, systolic blood pressure, diastolic blood pressure, and cholesterol decreased significantly by 4·9 (95% CI 4·0–5·9) mm Hg, 3·8 (3·2–4·4) mm Hg, and 0·45 (0·40–0·51) mmol/L, respectively, and we recorded a small and non-significant increase for haemoglobin A1c (0·04% [−0·04 to 0·13]), p=0·290).

Interpretation

We recorded additional, although small, benefits from our culturally tailored care package that were greater than the secular changes achieved in the UK in recent years. Stricter targets in general practice and further measures to motivate patients are needed to achieve best possible health-care outcomes in south Asian patients with diabetes.

Funding

Pfizer, Sanofi-Aventis, Servier Laboratories UK, Merck Sharp & Dohme/Schering-Plough, Takeda UK, Roche, Merck Pharma, Daiichi-Sankyo UK, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Bristol-Myers Squibb, Solvay Health Care, and Assurance Medical Society UK.

Introduction

Patients of south Asian ethnic background (UK decennial census categories Indian, Pakistani, Bangladeshi, and other Asians) with type 2 diabetes present special management challenges.1, 2 In the UK, prevalence of type 2 diabetes is four-fold to six-fold higher in people from south Asia than in white Europeans.3 Furthermore, onset can be more than a decade earlier and the risk of cardiovascular and renal complications greater in patients from south Asia, with higher morbidity and 50% higher mortality.4 Health-care delivery in this population is more challenging because of cultural, communication, and comprehension difficulties, which along with social deprivation further complicate the achievement of defined targets.5, 6 Payments for UK general practices based on their achievement of quality (quality and outcomes framework [QOF])7 targets do not distinguish different ethnic groups.

Enhanced care packages based in the community have been associated with improved metabolic outcomes in some ethnic groups8 but have not been fully assessed in large randomised controlled trials. Such trials are scarce in people of south Asian ethnic origin.9 The United Kingdom Asian Diabetes Study (UKADS) assessed a community-based complex intervention that aimed to reduce cardiovascular risk in south Asian people with type 2 diabetes. The intervention package was tailored to the needs of the south Asian community and consisted of additional time with a practice nurse, Asian link workers, and input from diabetes-specialist nurses, who were working to protocols to achieve clearly defined targets. The UKADS study hypothesis was that an enhanced care package for diabetes would improve cardiovascular risk profile in patients of south Asian origin, with established type 2 diabetes.

Section snippets

Study design and patients

In line with recognised complex intervention evaluations10 and following a protocol informed by a pilot study,11 we undertook a large cluster randomised controlled trial from March, 2004 to April, 2007. 21 general practices (seven in Coventry [500 patients] and 14 in Birmingham, UK [986 patients]) with a very high proportion (more than 80%) of south Asian patients were included in this cluster randomised controlled trial. Between March 2004 and April 2005, nine practices were randomised to

Results

The figure shows the trial profile. 1486 patients of south Asian ethnic origin, with established type 2 diabetes, consented to take part and were included in the study; 500 (34%) from Coventry and 986 (66%) from Birmingham.

Table 2 shows the baseline risk-factor profile for the intervention and control groups. Mean age for the whole group was 57·0 (SD 11·9) years. Differences observed between groups for sex, age, duration of diabetes, and treatment for diabetes were not significant. The

Discussion

Our results confirm that the achievement of targets set by national and international advisory bodies poses a major challenge for south Asian ethnic groups in inner-city general practices.12, 13, 14, 21 At baseline, many of our patients had haemoglobin A1c greater than 7%, blood pressure greater than 130/80 mm Hg, and total cholesterol greater than 4 mmol/L, which are higher than targets recommended by international standards for diabetes care. After 2 years in which secular changes included

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