Process evaluation of a patient-centred, patient-directed, group-based education program for the management of type 2 diabetes mellitus.

AIM The present study developed and evaluated a patient-centred, patient-directed, group-based education program for the management of type 2 diabetes mellitus. METHODS Two frameworks, the Medical Research Council (MRC) framework for developing and evaluating complex interventions and the RE-AIM framework were followed. Data to develop the intervention were sourced from scoping of the literature and formative evaluation. Program evaluation comprised analysis of primary recruitment of participants through general practitioners, baseline and end-point measures of anthropometry, four validated questionnaires, contemporaneous facilitator notes and telephone interviews with participants. RESULTS A total of 16 participants enrolled in the intervention. Post-intervention results were obtained from 13 participants, with an estimated mean change from baseline in weight of -0.72 kg (95%CI -1.44 to -0.01), body mass index of -0.25 kg/m2 (95%CI -0.49 to -0.01) and waist circumference of -1.04 cm (95%CI -4.52 to 2.44). The group education program was acceptable to participants. The results suggest that recruitment through general practitioners is ineffective, and alternative recruitment strategies are required. CONCLUSIONS This patient-centred, patient-directed, group-based intervention for the management of type 2 diabetes mellitus was both feasible and acceptable to patients. Health professionals should consider the combined use of the MRC and RE-AIM frameworks in the development of interventions to ensure a rigorous design process and to enable the evaluation of all phases of the intervention, which will facilitate translation to other settings. Further research with a larger sample trialling additional recruitment strategies, evaluating further measures of effectiveness and utilising lengthier follow-up periods is required.