XXXX : randomised controlled trial protocol.

@entity1 @entity308 @entity6 @entity6661 @entity148 @entity65
BACKGROUND: @entity6 ( @entity6 ) is common, affecting nearly 400 million @entity1 worldwide. Achieving good health for @entity1 with @entity6 requires active self-management; however, uptake of self-management education is poor, and there is an urgent need to find better, more acceptable, cost-effective methods of providing self-management support. Web-based self-management support has many potential benefits for @entity1 and health services. The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for @entity1 with @entity6 . METHODS: This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with @entity6 who are registered with participating general practices in England. @entity1 will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for @entity1 with @entity6 which addresses medical, emotional, and role management, called Healthy Living for @entity1 with type 2 @entity6 ( @entity6 ) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and @entity6 , measured by the Problem Areas In @entity6 (PAID) questionnaire. Secondary outcomes include @entity65 factors, @entity308 and @entity148 , and self-efficacy for self-management of @entity6 . Health economic data include health service use, costs due to the intervention, and EQ-5D for calculation of Quality Adjusted Life Years (QALYS). Data will be collected at baseline, 3  months and 12  months, with the primary endpoint at 12  months. Practice nurses, blinded to @entity1 allocation, collect clinical data; @entity1 complete online questionnaires for @entity1 reported measures. A sample size of 350 recruited @entity1 allows for @entity6661 of up to 15  % and will provide 90  % power of detecting at a 5  % significance level a true average difference in the PAID score of 4.0 and 0.25  % change in HbA1c (both small effect sizes). The analysis will follow a pre-specified analysis plan, based on comparing the groups as randomised (intention-to-treat). DISCUSSION: The findings of this trial are likely to be of interest to policy makers, clinicians, and commissioners, all of whom are actively seeking additional forms of self-management support for @entity1 with @entity6 . TRIAL REGISTRATION: The Trial Registration number is ISRCTN 02123133 ; date of registration 14.2.13.
