title: A pilot randomised controlled trial of a preconsultation web-based intervention to improve the care quality and clinical outcomes of diabetes outpatients (DIAT).
abstract: BACKGROUND
  Diabetes is a chronic condition associated with many long-term complications. People with diabetes need to actively manage their condition, which can be complex. In consultations with healthcare professionals, patients receive advice about their diabetes but do not always discuss things which concern them, perhaps because of the perceived limited time or embarrassment. We want to test a 'preconsultation' intervention in which the patient is supported by a healthcare assistant to complete a web-based intervention aimed at producing an agenda to help them identify important areas for discussion in the consultation. Use of this agenda may enable the patient to play a more active role in that consultation and consequently become more confident, and hence more successful, in managing their condition.
  
  
  METHODS
  In this pilot randomised controlled trial, 120 people with diabetes will be randomised with equal allocation to receive the intervention or usual clinical care. The primary outcome is reduction in glycosylated haemoglobin(HbA1c). Secondary outcomes are patient-reported communication, enablement, self-care activity, diabetes-dependent quality of life, empowerment, satisfaction, health-related quality of life and resource use. The aim of the pilot study was to estimate parameters to inform the design of the definitive trial. Follow-up on quantitative outcomes will be at 3 and 6 months. A nested qualitative study will collect data on the patients' experiences of producing an agenda. Resource use data and medication use will also be collected via a review of medical records for a sample of participants.
  
  
  BACKGROUND
  Approval was granted by the NHS Research Ethics Committee North West-Preston (13/NW/0123). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. Results will also be disseminated to trial participants via workshops led by lay coapplicants.
  
  
  BACKGROUND
  ISRCTN75070242.
authors.affiliation: Institute for Health Services Research, University of Exeter Medical School, Exeter, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Frost
authors.forename: Rob
authors.initials: R
authors.lastname: Anderson
authors.forename: Catherine
authors.initials: C
authors.lastname: Argyle
authors.forename: Mark
authors.initials: M
authors.lastname: Daly
authors.forename: Faith
authors.initials: F
authors.lastname: Harris-Golesworthy
authors.forename: Jim
authors.initials: J
authors.lastname: Harris
authors.forename: Andy
authors.initials: A
authors.lastname: Gibson
authors.forename: Wendy
authors.initials: W
authors.lastname: Ingram
authors.forename: Jon
authors.initials: J
authors.lastname: Pinkney
authors.forename: Obioha C
authors.initials: OC
authors.lastname: Ukoumunne
authors.forename: Bijay
authors.initials: B
authors.lastname: Vaidya
authors.forename: Jane
authors.initials: J
authors.lastname: Vickery
authors.forename: Nicky
authors.initials: N
authors.lastname: Britten
keywords: Qualitative Research; Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT; World Wide Web technology < BIOTECHNOLOGY & BIOINFORMATICS
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