HeLP-Diabetes: randomised controlled trial protocol

Elizabeth Murray, Charlotte Dack, Maria Barnard, Andrew Farmer, Susan Michie, Kingshuk Pal, Steve Parrott, Jamie Ross, Michael Sweeting, Bindie Wood, Lucy Yardley, Jinshuo Li

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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.
Original languageEnglish
JournalBMC Health Services Research
Volume15
Issue number578
Early online date29 Dec 2015
DOIs
Publication statusPublished - 2015

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  • Cite this

    Murray, E., Dack, C., Barnard, M., Farmer, A., Michie, S., Pal, K., Parrott, S., Ross, J., Sweeting, M., Wood, B., Yardley, L., & Li, J. (2015). HeLP-Diabetes: randomised controlled trial protocol. BMC Health Services Research, 15(578). https://doi.org/10.1186/s12913-015-1246-9