Study protocol
The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial
1 Centre for Primary Care, Institute of Population Health, University of Manchester, Oxford Road, M13 9PL, Manchester, UK
2 Health Sciences, University of Southampton, Highfield Campus, 12 University Road, SO17 1BJ, Southampton, UK
3 Centre for Health Economics, University of York, YO10 5DD, York, Heslington, UK
4 Primary Care & Health Services, University of Keele, ST5 5BG, Staffordshire, UK
Trials 2013, 14:28 doi:10.1186/1745-6215-14-28
Published: 28 January 2013Abstract
Background
Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease.
Methods/Design
The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial.
Discussion
The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage.
Trial registration
Trial registration reference: ISRCTN45433299
