Table 3.
Enrolment, intervention, and assessment schedule
| 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 | |||||
Abbreviation: DLQI Dermatology Life Quality Index, EQ-5D European Quality of life 5 Dimensions, LS-PGA Lattice-System Physician's Global Assessment, PRO patient-reported outcome
aEQ-5D is collected for use in the health-economy analysis