Assessing a person-centred, culturally sensitive intervention for type 2 diabetes in persons with non-Western backgrounds: A mixed-methods realist evaluation protocol for the ACCT2 study (Preprint)

Abstract

BACKGROUND People from ethnic minority backgrounds have a 2.5 times higher incidence of type 2 diabetes than ethnic Danes. They often face negative experiences with healthcare professionals, leading to mistrust and unequal treatment due to diverse health perceptions. A person-centred, culturally adapted approach focusing on knowledge, motivation, culture, beliefs, and socioeconomic support can improve self-care, diabetes management, and treatment adherence among persons from ethnic minority backgrounds. OBJECTIVE This mixed-methods realist evaluation protocol aims to understand how a person-centred and culturally sensitive course of treatment in individuals with type 2 diabetes and non-Western Backgrounds (The ACCT2 study) works. METHODS This study, embedded within a randomised controlled trial, the ACCT2 study, utilises a realist evaluation to assess what works, for whom it is most effective, and under what circumstances it is likely to be effective, alongside the causal effectiveness examined in the RCT. Our realist evaluation follows three phases: 1) Developing, 2) Testing, and 3) Refining initial program theories. Data will be collected through semi-structured interviews and survey data. A thematic analysis guided by a predefined codebook based on our initial program theories will be conducted. RESULTS The results will inform revisions to the hypothetical and theoretical initial program theories, ensuring a comprehensive model that accurately reflects the complex interactions between context, mechanisms, and outcomes in the ACCT2 study. CONCLUSIONS This RE is expected to support the RCT by offering insights applicable to real-life clinical settings. The anticipated impact includes aiding the future development and implementation of interventions for persons with ethnic minority backgrounds and T2D. CLINICALTRIAL This study is registered as a component of the ACCT2 study (ID: NCT06147245)