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/m2 ) were similar in the two groups. Median HbA1c [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 HbA1c , 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.

[Supporting patients in self-management: moving to a personalised approach]. / Ondersteuning van patiënten bij zelfmanagement.

OBJECTIVE: The aim of this research was to assess the effect of providing personalised self-management support on patient activation (knowledge, skills, self-efficacy) and self-management behaviour. DESIGN: Cluster randomised trial in 15 general practices (Dutch Trial Register No.: NTR 3960). METHOD: Patients aged 18 years or older with a chronic condition were invited to participate in the study. The Self-Management Screening (SeMaS) questionnaire - which illustrates barriers to self-management - was used as a tool for personalised self-management support. Nurse practitioners in the intervention practices were trained for 2 hours in using SeMaS and personalising self-management support on the basis of the SeMaS profile. At baseline and after 6 months, patients filled in questionnaires on patient activation (PAM-13) and lifestyle. Using data from the questionnaires and medical records, the use of individual care plans, referrals to self-management interventions, self-monitoring and healthcare use were assessed. We used a multiple multilevel regression model for data analysis. RESULTS: After 6 months, no difference was found in patient activation between the control group (n = 348) and the intervention group (n = 296). 29.4% of the patients in the intervention group performed self-monitoring, versus 15.2% in the control group (regression coefficient r = 0.9, p = 0.01). In the per-protocol analysis (control n = 348; intervention n = 136), the number of individual care plans (r = 1.3, p = 0.04) and the number of patients performing self-monitoring (r = 1.0; p = 0.01) were higher in the intervention group. CONCLUSION: Personalised self-management support with the use of the SeMaS method stimulates self-monitoring and the use of individual care plans. The intervention had no effect on patient activation or lifestyle. Given the positive secondary outcomes, the further potential of the tool should be researched.