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Open Access 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

Christian Blickem1*, Tom Blakeman1, Anne Kennedy2, Peter Bower1, David Reeves1, Caroline Gardner1, Victoria Lee1, Carolyn Chew-Graham4, Gerry Richardson3, Helen Brooks1, Shoba Dawson1, Rahena Mossabir1, Praksha Jariwala1, Angela Swallow1, Evan Kontopantelis1, Hannah Gaffney1, Nicola Small1, Eldon Spackman3 and Anne Rogers2

Author Affiliations

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

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Trials 2013, 14:28  doi:10.1186/1745-6215-14-28

Published: 28 January 2013

Abstract

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

Keywords:
Vascular disease; Chronic kidney disease; Self-management; Randomized controlled trial; Social disadvantage; Social networks; Social prescribing; Minimally disruptive medicine