title: Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial.
abstract: BACKGROUND
  Individuals with a learning disability (LD) are at higher risk of developing type 2 diabetes, but LD is not straightforward to define or identify, especially at the milder end of the spectrum, which makes case finding difficult. While supported self-management of health problems is now established, current material is largely educational and didactic with little that facilitates behavioural change. The interaction between the person with diabetes and others supporting their care is also largely unknown. For these reasons, there is considerable work needed to prepare for a definitive trial. The aim of this paper is to publish the abridged protocol of this preparatory work.
  
  
  METHODS
  Phase I is a prospective case-finding study (target n = 120 to 350) to identify and characterise potential participants, while developing a standardised supported self-management intervention. Phase II is a randomised feasibility trial (target n = 80) with blinded outcome assessment. Patients identified in Phase I will be interviewed and consented prior to being randomised to (1) standard treatment, or (2) supported self-management. Both arms will also be provided with an 'easy read' accessible information resource on managing type 2 diabetes. The intervention will be standardised but delivered flexibly depending on patient need, including components for the participant, a supporter, and shared activities. Outcomes will be (i) robust estimates of eligibility, consent and recruitment rates with refined recruitment procedures; (ii) characterisation of the eligible population; (iii) a standardised intervention with associated written materials, (iv) adherence and negative outcomes measures; (v) preliminary estimates of adherence, acceptability, follow-up and missing data rates, along with refined procedures; and (vi) description of standard treatment.
  
  
  CONCLUSIONS
  Our study will provide important information on the nature of type 2 diabetes in adults with LD living in the community, on the challenges of identifying those with milder LD, and on the possibilities of evaluating a standardised intervention to improve self-management in this population.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK. r.e.a.walwyn@leeds.ac.uk.
authors.forename: Rebecca E A
authors.initials: RE
authors.lastname: Walwyn
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. a.m.russell@leeds.ac.uk.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Russell
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. l.d.bryant@leeds.ac.uk.
authors.forename: Louise D
authors.initials: LD
authors.lastname: Bryant
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK. a.j.farrin@leeds.ac.uk.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK. a.wright-hughes@leeds.ac.uk.
authors.forename: Alexandra M
authors.initials: AM
authors.lastname: Wright-Hughes
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK. e.h.graham@leeds.ac.uk.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Graham
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. c.t.hulme@leeds.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. j.odwyer@leeds.ac.uk.
authors.forename: John L
authors.initials: JL
authors.lastname: O'Dwyer
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. g.latchford@leeds.ac.uk.
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Latchford
authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Leeds, UK. alisonstansfield@nhs.uk.
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Stansfield
authors.affiliation: Mid Yorkshire Hospitals NHS Trust, Wakefield, UK. Dinesh.Nagi@midyorks.nhs.uk.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Nagi
authors.affiliation: Division of Cardiovascular and Diabetes Research, University of Leeds, Leeds, UK. r.ajjan@leeds.ac.uk.
authors.forename: Ramzi A
authors.initials: RA
authors.lastname: Ajjan
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK. a.o.house@leeds.ac.uk.
authors.forename: Allan O
authors.initials: AO
authors.lastname: House
mesh_terms: D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004739:England; D005240:Feasibility Studies; D006040:Goals; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007859:Learning Disabilities / Q000150:complications / Q000175:diagnosis / Q000523:psychology*; D010349:Patient Compliance; D019989:Persons with Intellectual Disabilities / Q000523:psychology*; D012107:Research Design; D012648:Self Care; D012944:Social Support; D013997:Time Factors; D016896:Treatment Outcome