Table 1.
|
Study period |
||||
---|---|---|---|---|---|
|
Enrolment |
Allocation |
Post-allocation |
Close-out |
|
Time point | -T 1 | T 0 | T 1 | T 2 | T 3 |
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.