title: HeLP-Diabetes: randomised controlled trial protocol.
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The Trial Registration number is ISRCTN 02123133 ; date of registration 14.2.13.
authors.affiliation: eHealth Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. Elizabeth.murray@ucl.ac.uk.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Murray
authors.affiliation: Psychology Department, University of Bath, Claverton Down, Bath, BA2 7AY, UK. c.n.dack@bath.ac.uk.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Dack
authors.affiliation: The Whittington Hospital NHS Trust, Magdala Avenue, London, N19 5NF, UK. Maria.barnard1@nhs.net.
authors.forename: Maria
authors.initials: M
authors.lastname: Barnard
authors.affiliation: Department of Primary Care Health Sciences, University of Oxford, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. Andrew.farmer@phc.ox.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Farmer
authors.affiliation: Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK. jinshuo.li@york.ac.uk.
authors.forename: Jinshuo
authors.initials: J
authors.lastname: Li
authors.affiliation: UCL Centre for Behaviour Change, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. s.michie@ucl.ac.uk.
authors.forename: Susan
authors.initials: S
authors.lastname: Michie
authors.affiliation: eHealth Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. k.pal@ucl.ac.uk.
authors.forename: Kingshuk
authors.initials: K
authors.lastname: Pal
authors.affiliation: Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK. steve.parrott@york.ac.uk.
authors.forename: Steve
authors.initials: S
authors.lastname: Parrott
authors.affiliation: eHealth Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. Jamie.Ross@ucl.ac.uk.
authors.forename: Jamie
authors.initials: J
authors.lastname: Ross
authors.affiliation: Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. mjs212@medschl.cam.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Sweeting
authors.affiliation: eHealth Unit, Research Department of Primary Care and Population Health, University College London, Upper Floor 3, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. Bindietherealme@hotmail.com.
authors.forename: Bindie
authors.initials: B
authors.lastname: Wood
authors.affiliation: Centre for Application of Health Psychology, University of Southampton, Building 44, Highfield Campus, Southampton, SO17 1BJ, UK. L.Yardley@soton.ac.uk.
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology; D003362:Cost-Benefit Analysis; D003863:Depression / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000191:economics / Q000523:psychology / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000191:economics / Q000523:psychology / Q000628:therapy; D004739:England; D019317:Evidence-Based Medicine; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012307:Risk Factors; D012648:Self Care / Q000191:economics / Q000379:methods*; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin