Enhancing type 2 diabetes care by an individualized and group-based therapeutic patient education program: study protocol for a cluster randomized trial

Background: Type 2 diabetes (T2D) presents a significant challenge to health systems and its prevalence is projected to increase. T2D is significantly influenced by lifestyle factors, including diet and physical activity. This makes therapeutic patient education (TPE) a pivotal component of T2D treatment strategies. While in some countries, like Germany and the UK, TPE elements like physician counselling regarding lifestyle changes (e.g. nutrition, smoking, exercise) and participation in diabetes education courses, are part of structured nationwide disease management programs, in Switzerland, TPE elements are rarely part of the standard of care protocols. Our goal is to evaluate whether an interdisciplinary and individualized T2D program including TPE elements improves patients’ health outcomes. Methods: The study is a multi-center cluster randomized controlled trial in the canton of Geneva in Western Switzerland. We aim to include a minimum of 154 recently diagnosed T2D patients from around 30 primary care physician (PCP) practices. Practices are randomized with a 1:1 patient allocation ratio to either intervention or control group using covariate constrained randomization. The intervention lasts 12 months with a 6-month follow-up and consists of two steps. First, PCPs in the intervention group and associated healthcare professionals (e.g., dieticians, physical therapists) are trained in interprofessional group sessions on TPE elements by specialists. Second, patients follow an individualized treatment plan which is designed within an initial quality circle with their PCP, other healthcare professionals, a TPE specialist, a dedicated study manager and other patients. The treatment plan is accompanied by regular Patient-reported outcome measure (PROM) collections, which are discussed in patients’ regular PCP visits. Patients in the control group follow standard of care. Primary endpoint is the 12-months mean change in HbA1c levels, secondary endpoints are the 18-months mean change in HbA1c levels, the 12- and 18-months mean changes in patient-reported outcomes (EQ-5D-5L, DIAB-Q), mean changes in medical outcomes (blood pressure, body composition, medication intake), and patient experience. We further evaluate cost-effectiveness from the payer perspective. Discussion: A positive evaluation of the study can inform a wider roll-out of the T2D program within Switzerland and be a cornerstone for better patient health outcomes for T2D patients. Trial registration : ClinicalTrials.gov: NCT06774950.