Theory‐based diabetes self‐management education with pre‐selection of participants: a randomized controlled trial with 2.5 years’ follow‐up (ELDES Study)

AIMS: To evaluate the (cost‐)effectiveness of Beyond Good Intentions (BGI), a 12‐week group‐based, nurse‐led self‐management programme, in terms of cardiovascular risk factors, self‐management and quality of life, after 2.5 years of follow‐up in pre‐selected individuals with known Type 2 diabetes of up to 5 years’ duration. METHODS: A parallel randomized controlled trial comparing BGI with usual care, based on a self‐management screening questionnaire, was conducted in 43 general practices after pre‐selection of participants. After 2.5 years of follow‐up, the between‐group changes in the abovementioned variables were assessed using analysis of covariance. RESULTS: A total of 108 participants (BGI group, n =56; control group, n =52) were included. Changes over time in BMI (–0.4 vs –0.5 kg/m(2)) were similar in the two groups. Median HbA(1c) [BGI group 47 mmol/mol (6.5%); control group: 49 mmol/mol (6.6%)] and mean systolic blood pressure (BGI group: 132±13 mmHg; control group: 133±14 mmHg) were well controlled at baseline and no intervention effect was found. LDL cholesterol levels decreased from 2.4 to 2.2 mmol/l in the control group and remained stable at 2.6 mmol/l in the intervention group (P=0.032). No intervention effect was found for self‐management or quality of life. CONCLUSION: In contrast to the first BGI study, we did not observe significant effects of the BGI intervention, despite pre‐selection of individuals. In diabetes populations with target levels for HbA(1c), systolic blood pressure and LDL cholesterol, no further beneficial effects can be expected from self‐management programmes with regard to biomedical factors and quality of life.