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.
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
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.


CONCLUSIONS
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.


BACKGROUND
Trial registration reference: ISRCTN45433299.
Centre for Primary Care, Institute of Population Health, University of Manchester, Oxford Road, Manchester M13 9PL, UK. christian.blickem@manchester.ac.uk
Christian
C
Blickem
Tom
T
Blakeman
Anne
A
Kennedy
Peter
P
Bower
David
D
Reeves
Caroline
C
Gardner
Victoria
V
Lee
Carolyn
C
Chew-Graham
Gerry
G
Richardson
Helen
H
Brooks
Shoba
S
Dawson
Rahena
R
Mossabir
Praksha
P
Jariwala
Angela
A
Swallow
Evan
E
Kontopantelis
Hannah
H
Gaffney
Nicola
N
Small
Eldon
E
Spackman
Anne
A
Rogers
D001794:Blood Pressure; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D019033:Delivery of Health Care, Integrated / Q000191:economics*; D004739:England; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006297:Health Services Accessibility / Q000191:economics; D006801:Humans; D010174:Pamphlets; D010353:Patient Education as Topic / Q000191:economics*; D011320:Primary Health Care / Q000191:economics*; D011788:Quality of Life; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care / Q000191:economics*; D012720:Severity of Illness Index; D012944:Social Support; D013689:Telephone / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*