Abstract
BackgroundThe 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.MethodsUsing 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.ResultsThe 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.ConclusionThis 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.
Highlights
The objectives of this study were twofold (i) to develop the Diabetes Manual, a selfmanagement 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
Our research questions were i) How could self-efficacy theory inform the structure and process of the Diabetes Manual programme in order to influence the behaviour of health care professionals and people with diabetes? ii) How could the self-management needs of people with type 2 diabetes be addressed within the proposed structure? iii) Would the proposed Diabetes Manual format have face validity for people with the target population and primary care professionals?
The workbook and component development work took the content listed in table 1, along with the original Heart Manual, and established a Diabetes Manual intervention incorporating some existing content, new original diabetes material and an efficacy enhancing structure designed to weave throughout the workbook and the programme as a whole
Summary
The objectives of this study were twofold (i) to develop the Diabetes Manual, a selfmanagement 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. The past decade has seen an international trend towards providing primary care based diabetes services with patient education and self-management at the forefront. The International Diabetes Foundation (IDF) [1] standards advocate that "implementation of diabetes education is learner-centred, facilitates cognitive learning, behaviour change and self-management". These are challenging goals for health care providers to uphold but are being incorporated into national health policies. BMC Family Practice 2006, 7:70 http://www.biomedcentral.com/1471-2296/7/70 develop their confidence, skills and knowledge, engage in shared decision making and to provide theory-based structured education [5,6,7]. It has been proposed that such education should meet four criteria [8]: (i) have a structured, written curriculum (ii) have trained educators (iii) be quality assured, and (iv) be audited
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