Study period | |||||||
---|---|---|---|---|---|---|---|
Time points | Enrolment Baseline | Allocation Baseline | Post allocation | ||||
Baseline | Week 12 | Week 24 | Week 36 | Week 48 (close out) | |||
Enrolment | |||||||
Eligibility screen | x | ||||||
Informed consent | x | ||||||
Allocation: Intervention arm (topical drugs and improved support) or non-intervention arm (topical drugs) | x | ||||||
Topical drugs | |||||||
Assessments: | |||||||
Socio-demographics | x | ||||||
Primary outcome: | |||||||
LS-PGA | x | x | x | X | x | ||
Secondary outcomes: | |||||||
Rates of adherence: | |||||||
Primary adherence (proportion of filled new prescriptions) | x | ||||||
Secondary adherence (by proportion of consumed amount of prescribed medication and in a study-specific PRO questionnaire) | x | ||||||
DLQI (PRO questionnaire) | x | x | x | X | x | ||
EQ-5Da (PRO questionnaire) | x | x | |||||
Total cost of anti-psoriatic treatment | x | x |