Visits | Screening | Baseline and intervention Day 0 | 6 week follow-up | 6 month follow-up | 12 month follow-up | 24 month follow-up |
---|---|---|---|---|---|---|
Diagnosis | ✓ | |||||
Eligibility Screening | ✓ | |||||
GP pathway only: Written Informed Consent for contact by Keele RN and completion of Consent to Contact Fax Form | ✓ | |||||
GP pathway only: Keele RN telephone call to potential participant | ✓ | |||||
GP pathway only: Confirmation of Eligibility and Randomisation | ✓ | |||||
Informed consent by authorised local Investigator | ✓ | |||||
Participant Baseline Data self-report Questionnaires | ✓ | |||||
Web randomisation | ✓ | |||||
Administration of study intervention | ✓ | |||||
Participant self-report follow up Questionnaires | ✓ | ✓ | ✓ | ✓ |