By the same authors

From the same journal

From the same journal

HeLP-Diabetes: randomised controlled trial protocol

Research output: Contribution to journalArticle

Published copy (DOI)

Author(s)

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

Department/unit(s)

Publication details

JournalBMC Health Services Research
DatePublished - 29 Dec 2015
Issue number578
Volume15
Number of pages8
Pages (from-to)1-8
Original languageEnglish

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 is ISRCTN 02123133 ; date of registration 14.2.13.

Discover related content

Find related publications, people, projects, datasets and more using interactive charts.

View graph of relations