Development and testing of culturally sensitive patient information material for Turkish, Polish, Russian and Italian migrants with depression or chronic low back pain (KULTINFO): study protocol for a double-blind randomized controlled trial

BACKGROUND Many of the approximately 15 million people with a migration background living in Germany (19% of the population) are inadequately reached by existing healthcare provision. In the literature, the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study, culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain. In this respect, it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation. METHODS/DESIGN The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany. Primary care patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group. In the intervention group, culturally sensitive patient information will be handed to the patient at the end of the physician consultation, while in the control group, standard translated patient information material will be provided. The patients will be surveyed by means of questionnaires following the consultation as well as after 8 weeks and 6 months. In addition to the primary outcome (subjective usefulness), several patient- and physician-rated secondary outcomes will be considered. DISCUSSION The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation. TRIAL REGISTRATION Deutsches Register Klinischer Studien (DRKS-ID) DRKS00004241 and Universal Trial Number (UTN) U1111-1135-8043.