Table 3.
IBD-BOOST RCT screening and data collection schedule (SPIRIT figure)
Pre-consent | Pre-baseline | Baseline | 6 months | 12 months | Ongoing or during treatment | |
---|---|---|---|---|---|---|
Screen for eligibility | X | |||||
Study within a trial (SWAT) randomisation | X | |||||
Invite reply | X | |||||
Consent form | X | |||||
Red flags assessment | X | |||||
Adverse event form | X | |||||
Drop-out event form | X | |||||
Faecal calprotectin test | X | |||||
Baseline case report form | X | |||||
Follow-up case report form | X | X | ||||
Participant qualitative interviews | X | X | ||||
Clinician qualitative interviews | X | X | ||||
Randomisation | X | |||||
Nurse support | X | |||||
Intervention website user query | X |