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

Table 1 Study schedule

	Study period
	Enrolment	Allocation	Post-allocation		Close-out
Time point	-T₁	T₀	T₁	T₂	T₃
Enrolment
Eligibility screen	×
Informed consent	×
Allocation		×
Interventions
Culturally sensitive patient information material			×
Standard translated patient information material			×
Assessments
General practitioner rating
Diagnosis	×
Treatment	×
Self-rating
Demographic information (age, sex, migration background, mother tongue, German language proficiency, education)*			×
Acculturation (SMAS)			×
Usefulness of information material (USE)			×	×	×
Knowledge of the disease*			×	×	×
Perceived cultural sensitivity*			×
Behaviour change*				×	×
Illness perception (Brief-IPQ)			×	×	×
Symptom self-rating (PHQ-9, Core set)			×	×	×
Acceptance of the disease or treatment*			×	×	×
Adherence (MOS)				×	×
Satisfaction with physician (ZAPA)			×	×	×
Health care utilization*				×	×
Quality of life (WHO-5)			×	×	×

-T₁, within the consultation; T₀, after informed consent has been given; T₁, after consultation; T₂, 8 weeks; T₃, 6 months; Brief-IPQ, Brief Illness Perception Questionnaire; MOS, Medical Outcomes Study (general adherence); PHQ-9, 9-item version of the Patient Health Questionnaire; SMAS, Stephenson Multigroup Acculturation Scale; USE, Usefulness Scale for Patient Information Material; WHO-5, WHO 5 Well-being Index; ZAPA, questionnaire assessing satisfaction with outpatient care, with a focus on patient participation; *, self-constructed items.

ISSN: 1745-6215