Complex intervention development for diabetes self-management

Aim. The aim of this paper is to present the development and evaluation of the Self-Efficacy Goal Achievement nursing intervention for type 2 diabetes. Backround. Systematic reviews support the clinical effectiveness of diabetes self-management programmes that are collaborative, involve biomedical feedback and are goal focussed. Method. The self-efficacy goal achievement intervention comprises patient goal-setting consultations with practice nurses using the Diabetes Management Self-Efficacy Scale. The United Kingdom Medical Research Council framework for the evaluation of complex interventions by randomized controlled trial was used to develop and evaluate the intervention. The 'preclinical' study included literature analysis and findings from parallel studies. The 'phase I' study, carried out in spring 2003, was a small trial of the intervention, evaluation of its feasibility, identification of appropriate outcome measures for future trials and improvement of the components, with two nurses and eight patients. Findings. The 'preclinical' study supported continued intervention development. The 'phase I' intervention resulted in a mean reduction in participants' glycosylated haemoglobin of 0.93% between baseline and 3-months postintervention. It showed an increase in patient self-efficacy and some decline in patient diabetes treatment satisfaction. Qualitative data recorded therapeutically desirable behavioural changes in all participants. Follow-up consultations and goal evaluation were found to be important to patients. Nurses reported (i) reservations about the repeated use of components of the intervention, which were felt to be repetitive and restrictive; and (ii) the time commitment required to deliver the educational sessions. Conclusions. Most phase I components were effective in delivering a feasible nursing intervention. The intervention has been adjusted to remove the less effective components and enhance the more effective. The outcome measures were appropriate for the intervention. A phase II trial is being developed to further test both the intervention and research protocol for comparing the intervention to an alternative.