Abstract
BackgroundSelf management is the cornerstone of effective preventive care in diabetes. Educational interventions that provide self-management skills for people with diabetes have been shown to reduce blood glucose concentrations. This in turn has the potential to reduce rates of complications. However, evidence to support type, quantity, setting and mode of delivery of self-management education is sparse.Objectives: To study the biophysical and psychological effectiveness of a brief psycho-educational intervention for type 1 diabetes in adults.Methods/DesignDesign: Randomised controlled clinical trial.Setting: Multidisciplinary specialist diabetes centre.Hypothesis: Our hypothesis was that the brief (2.5-day) intervention would be biophysically and psychologically effective for people with type 1 diabetes.Intervention: A brief psycho-educational intervention for type 1 diabetes developed by a multi-professional team comprising of a consultant diabetologist, a diabetes specialist nurse, a specialist diabetes dietician and a clinical health psychologist and delivered in 20 hours over 2.5 days.Primary outcomes: HbA1c and severe hypoglycaemia.Secondary outcomes: Blood pressure, weight, height, lipid profile and composite psychometric scales.Participants: We shall consent and recruit 120 subjects with postal invitations sent to eligible participants. Volunteers are to be seen at randomisation clinics where independent researcher verify eligibility and obtain consent. We shall randomise 60 to BITES and 60 to standard care.Eligibility Criteria: Type 1 diabetes for longer than 12 months, multiple injection therapy for at least two months, minimum age of 18 and ability to read and write.Randomisation: An independent evaluator to block randomise (block-size = 6), to intervention or control groups using sealed envelopes in strict ascendant order. Control group will receive standard care.Assessment: Participants in both groups would attend unblinded assessments at baseline, 3, 6 and 12 months, in addition to their usual care. After the intervention, usual care would be provided.Ethics approval: York Research Ethics Committee (Ref: 01/08/016) approved the study protocol.DiscussionWe hope the trial will demonstrate feasibility of a pragmatic randomised trial of BITES and help quantify therapeutic effect. A follow up multi-centre trial powered to detect this effect could provide further evidence.Trial registrationCurrent Controlled Trials ISRCTN75807800
Highlights
2 Freedom and control in day to day diabetes. 3 Principles of healthy eating. 4 Analysing food content & estimating carbohydrates. 5 Group exercise – analysing food content.Workbook Food analysis – practical exercises & daily comments. 1 scheduled phone support callFeedback from last session & Workbook
A follow up multi-centre trial powered to detect this effect could provide further evidence
In response to Department of Health initiatives [10] and in light of reported benefits in trials [4,6], we developed an educational and psychosocial intervention that is acceptable to people with diabetes, feasible and cost-effective in practice
Summary
In response to Department of Health initiatives [10] and in light of reported benefits in trials [4,6], we developed an educational and psychosocial intervention that is acceptable to people with diabetes, feasible and cost-effective in practice. This local study will test the feasibility of a multi-centre pragmatic randomised trial in this field, and provide evidence about the likely size of the therapeutic effect
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