HeLP-Diabetes: randomised controlled trial protocol. Issue 1 (June 2015)

• Record Type: Journal Article
• Authors: Murray, Elizabeth; Dack, Charlotte; Barnard, Maria; Farmer, Andrew; Li, Jinshuo; Michie, Susan; Pal, Kingshuk; Parrott, Steve; Ross, Jamie; Sweeting, Michael; Wood, Bindie; Yardley, Lucy
• Is Part Of: BMC health services research. Volume 15:Issue 1(2015)
• Page Start: 1
• Page End: 8
• Publication Date: 2015-06
• Subjects: Diabetes mellitus, Type 2 -- Self-care -- Internet -- Randomized controlled trial -- Primary health care -- Family practice; Public health -- Research -- Periodicals; Medical care -- Research -- Periodicals; 362.1072
• DOI: 10.1186/s12913-015-1246-9
• Languages: English
• ISSNs: 1472-6963

Abstract

Abstract Background Type 2 Diabetes Mellitus (T2DM) is common, affecting nearly 400 million people worldwide. Achieving good health for people with T2DM 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 patients 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 people with T2DM. Methods This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with T2DM who are registered with participating general practices in England. Participants will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for people with T2DM which addresses medical, emotional, and role management, called Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire. Secondary outcomes include cardiovascular risk factors, depression and anxiety, and self-efficacy for self-management of diabetes. 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 patient allocation, collect clinical data; patients complete online questionnaires for patient reported measures. A sample size of 350 recruited participants allows for attrition 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 people with T2DM. Trial registration The Trial Registration number isISRCTN 02123133 ; date of registration 14.2.13.