A study protocol for an evaluation of a diabetes self-management intervention for lower educated patients

Background:
Type 2 diabetes mellitus (T2DM) is a chronic disease which contributes to an increased disease burden worldwide. To reduce adverse events and complications, effective diabetes self-management is required. Research has shown that the self-management and glycaemic control of people with lower educational levels is often less managed than those of higher educated people. This implies that patients from lower educational groups require additional care for their diabetes self-management.
Purpose:
The purpose of this study is to assess the (cost-)effectiveness of a diabetes self-management program ‘Powerful Together With Diabetes’ (PTWD), which is specifically developed for patients from lower educational groups living with T2DM.
Methods:
The PTWD program is focused on attaining basic knowledge and skills for effective diabetes self-management. In a previous study (the DISC study), lower-educated participants enjoyed the PTWD program as well as improved their T2DM-related behaviours. The design of the study is an effectiveness-implementation hybrid type 2 trial. We will conduct mixed methods effectiveness, process and economic evaluations. To investigate the (cost-)effectiveness, a two-arm quasi-experimental trial will be conducted with a parallel a mixed method process evaluation. Study participants are patients from lower educational groups living with T2DM between 35 and 70 years old. Data will be collected with questionnaires, physical activity trackers and registration data from general practitioner registries. The primary outcome of the study is change in haemoglobin A1c (HbA1c) levels from baseline to 12 months. The secondary outcomes are use of primary and secondary care, medication use, blood biomarkers, health behaviours (e.g. physical activity), anthropometrics, and quality of life. To see if the results are maintained, we will measure the outcomes 24 months after baseline.

Practical implications: this study contributes to the evidence of interventions specifically designed for this population and to help lower educated diabetes patients

Funding: Funded by ZonMw, grant number 555003202