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These forms are password protected due to licensing regulations, if you do not have this password but require the form, please contact the study team.
Initial Contact
Once eligible people have been identified from the practice/clinic, if you are contacting them via post to begin with, a letter of invitation through the post to inform them about the study. Included alongside this should be the pre-screening information sheet. After 14 days of receiving this letter, you can then contact them to see if they would be interested in being screened.
Screening
All research sites will be involved in the screening procedures of the study. Please remember to log all screening activity on your screening log and to send this information to the trials manager each month.
When a person is screened positive they should be given a full information sheet. If they wish to participate in the trial, a baseline appointment needs to be organised, using the calendar you can see the researchers availability if they are responsible for taking consent and completing the baseline.
For any questions regarding a patients eligibility or ways in which to complete the assessments, please consult the Practice Manual.
Baseline Assessment
Before answering these questions, informed written consent needs to be completed.
The interviewer baseline questionnaire is to be completed by the researcher with each person who enters the trial.
The patient baseline questionnaire is to be completed by each person who enters the trial with assistance from the researcher when necessary.
Participants entering the trial will need to be randomised. Fill in the randomisation form and email this to the study administrator.
Follow up Assessments
Each person who enters the trial will have the following assessments done.
If you are unsure if you as the research site, or the UCL research team are completing these assessments, then please contact the study team
Serious Adverse Events
In the event of an adverse event, please follow the procedures in place.