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Key message

The study protocol describes a cluster randomized controlled trial evaluating an interdisciplinary and individualized program including therapeutic patient education (TPE) elements for people with type 2 diabetes (T2D) in the canton of Geneva, Switzerland. The goal of the study is to examine whether the program improves patients’ health outcomes.

Background

T2D is a growing challenge for health systems and is strongly influenced by lifestyle factors such as diet and physical activity. While in some countries, such as 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, TPE remains rarely integrated into standard care in Switzerland. As a result, evidence on the effectiveness of such programs in the Swiss context is still limited.

Methods

The study is a multi-center cluster randomized controlled trial conducted in the canton of Geneva. Around 30 primary care practices and at least 154 patients with T2D will be randomized to either an intervention group or standard care. The intervention consists of two components. First, primary care physicians (PCP) and other healthcare professionals undergo interprofessional training in TPE. Second, patients participate in an individualized treatment plan developed during an initial quality circle involving the PCP, other healthcare professionals, a TPE specialist, a dedicated study manager, and other patients. The intervention is complemented by the systematic collection and discussion of patient-reported outcome measures (PROMs). The primary endpoint is the 12-month change in HbA1c levels; secondary outcomes include 18-months mean change in HbA1c levels, mean changes in medical outcomes (blood pressure, body composition, medication intake), mean changes in PROM scores and patient experience. Cost-effectiveness from the payer perspective will also be evaluated.

Expected contribution

If successful, the study may support a wider roll-out of the T2D program within Switzerland and be a cornerstone for better patient health outcomes for T2D patients.

Publication
Ehlig, D., Sapin, M., Zeukeng, M.-J., Vogel, J., Barthassat, V., Favre, B., DaCosta, H., Tugay, K., Coendoz-Carron, S., Bumann, D., Coclet, J., Schaller, P., & Geissler, A. (2025). Enhancing type 2 diabetes care by an individualized and group-based therapeutic patient education program: Study protocol for a cluster randomized trial. Trials, 26(1), 577. https://doi.org/10.1186/s13063-025-09302-x

Full text available here.”