Abstract
BACKGROUND: Individuals from ethnic minority backgrounds have a 2.5 times higher incidence of type 2 diabetes (T2D) than ethnic Danes. They often face negative experiences with health care professionals, leading to unequal treatment. A person-centered and culturally adapted treatment approach can improve self-care, diabetes management, and treatment adherence. OBJECTIVE: This mixed methods realist evaluation (RE) protocol aims to understand how a person-centered and culturally sensitive course of treatment for T2D works, for whom it is most effective, and under what circumstances it is likely to be effective. METHODS: This RE is embedded within a 1-year randomized controlled trial, the Culturally Sensitive Course of Treatment for Individuals With T2D (ACCT2) study, for Arabic-, Turkish-, or Urdu-speaking individuals with suboptimal glycated hemoglobin (HbA(1c) ; ≥53 mmol/mol) or unmet individual targets at 2 consecutive visits. The RE follows three phases: (1) developing, (2) testing, and (3) refining initial program theories. Data are collected through semistructured interviews at 4 months (visit 4) and at the end of the intervention (visit 6). Survey data are collected at baseline and at the end of the intervention. We aim to recruit 16 to 20 intervention participants, including at least 2 men and 2 women from each language group. Qualitative data will be analyzed thematically using a predefined codebook, and survey data will be analyzed descriptively. RESULTS: As of December 2024, a total of 13 visits and 4 interviews had been completed. All baseline survey responses have been collected, along with 2 survey responses at the end of the intervention. Data analysis is pending. The results will inform revisions to the initial program theories, refining a comprehensive model that captures interactions between context, mechanisms, and outcomes. We anticipate disseminating the findings in the first half of 2026. CONCLUSIONS: This RE will support the randomized controlled trial by providing insights applicable to real-life clinical settings. The anticipated impact includes aiding the future development and implementation of interventions for the target groups. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69852.