HeLP-Diabetes: Randomised controlled trial protocol

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Article number578
JournalBMC Health Services Research
Volume15
Issue number1
DOIs
Publication statusPublished - 29 Dec 2015
Externally publishedYes

Bibliographical note

Funding Information:
This article presents independent research commissioned by the National Institute for Health Research (NIHR) through a Programme Grant for Applied Health Research (RP-PG-0609-10135). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. AF is an NIHR Senior Investigator and receives additional support from NIHR Oxford Biomedical Research Centre.

Publisher Copyright:
© 2015 Murray et al.

Keywords

  • Diabetes mellitus
  • Family practice
  • Internet
  • Primary health care
  • Randomized controlled trial
  • Self-care
  • Type 2

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