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

Abstract

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/m² ) 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.

Figure 1

Diabetes profile chart used during the individual session to explain the individual risk profile.

Figure 2

CONSORT 2010 flow diagram.