title: A study protocol for a pilot randomised trial of a structured education programme for the self-management of type 2 diabetes for adults with intellectual disabilities.
abstract: BACKGROUND
  The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID. This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.
  
  
  METHODS
  This trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.
  
  
  CONCLUSIONS
  The lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.
  
  
  BACKGROUND
  Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560 ) on 10 November 2014.
authors: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim BT37 0QB, Northern Ireland. l.taggart@ulster.ac.uk.
authors: Laurence
authors: L
authors: Taggart
authors: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim BT37 0QB, Northern Ireland. ve.coates@ulster.ac.uk.
authors: Vivien
authors: V
authors: Coates
authors: MRC Hub for Trials Methodology Research, Queen's University Belfast, Malone Road, Belfast, BT7 1NN, Northern Ireland. m.clarke@qub.ac.uk.
authors: Mike
authors: M
authors: Clarke
authors: Institute of Psychology, Ulster University, Northland Road, Derry, BT48 7JL, Northern Ireland. bp.bunting@ulster.ac.uk.
authors: Brendan
authors: B
authors: Bunting
authors: Leicester Diabetes Centre, University of Leicester, Gwendolen Road, Leicester LE5, England. melanie.davies@uhl-tr.nhs.uk.
authors: Melanie
authors: M
authors: Davies
authors: Leicester Diabetes Centre, University of Leicester, Gwendolen Road, Leicester LE5, England. marian.carey@uhl-tr.nhs.uk.
authors: Marian
authors: M
authors: Carey
authors: University of South Wales, Glyntaff Campus, Cardiff, CF37 4BD, Wales. ruth.northway@southwales.co.uk.
authors: Ruth
authors: R
authors: Northway
authors: Edinburgh Napier University, Sighthill Campus, Bankhead Avenue, Edinburgh, EH11 4DE, Scotland. m.brown@napier.ac.uk.
authors: Michael
authors: M
authors: Brown
authors: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim BT37 0QB, Northern Ireland. mn.truesdale@ulster.ac.uk.
authors: Maria
authors: M
authors: Truesdale-Kennedy
authors: Leicester Diabetes Centre, University of Leicester, Gwendolen Road, Leicester LE5, England. lorraine.martinstacey@uhl-tr.nhs.uk.
authors: Lorraine
authors: L
authors: Martin-Stacey
authors: Northern Health and Social Care Trust, Ulster, Rathlea House, Mountfern Complex, 8A Rugby Ave, Coleraine, BT52 1JL, Northern Ireland. gillian.scott@northerntrust.hscni.net.
authors: Gillian
authors: G
authors: Scott
authors: Edinburgh Napier University, Sighthill Campus, Bankhead Avenue, Edinburgh, EH11 4DE, Scotland. t.karatzias@napier.ac.uk.
authors: Thanos
authors: T
authors: Karatzias
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D015415:Biomarkers / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D017144:Focus Groups; D006442:Glycated Hemoglobin / Q000378:metabolism; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008607:Intellectual Disability / Q000175:diagnosis / Q000523:psychology*; D008297:Male; D010349:Patient Compliance; D010353:Patient Education as Topic; D019989:Persons with Intellectual Disabilities / Q000523:psychology*; D010865:Pilot Projects; D015397:Program Evaluation; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human