title: A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual.
abstract: BACKGROUND
  The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews.
  
  
  METHODS
  Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey.
  
  
  RESULTS
  The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations.
  
  
  CONCLUSIONS
  This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended.
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, UK. jackie.sturt@warwick.ac.uk
authors.forename: Jackie
authors.initials: J
authors.lastname: Sturt
authors.forename: Hafrun
authors.initials: H
authors.lastname: Taylor
authors.forename: Andrea
authors.initials: A
authors.lastname: Docherty
authors.forename: Jeremy
authors.initials: J
authors.lastname: Dale
authors.forename: Taylor
authors.initials: T
authors.lastname: Louise
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D001296:Audiovisual Aids; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008370:Manuals as Topic / Q000592:standards*; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D017060:Patient Satisfaction; D012648:Self Care / Q000379:methods* / Q000523:psychology; D020377:Self Efficacy; D011795:Surveys and Questionnaires; D013689:Telephone; D006113:United Kingdom