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When a new participant enters the trial, it is necessary to ensure all the initial paperwork is complete (consent form, survey 1, swab A and recruiter survey), arrange for collection of trial data as soon as possible from the clinic to ensure there are no problems, and that swab A has arrived at the laboratory.
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Participants for the individual interviews and focus groups will be asked to complete consent forms.
During the first visit, participants complete consent forms and fill in questionnaires on demographic, medical and obstetric history.
Staff interested in participating in the evaluation were asked to read the participant information and complete consent forms and return them by email to the researchers.
Eligible and interested patients return one to two weeks later to complete baseline questionnaires, to have baseline blood pressure, peak expiratory flow and forced expiratory volume measured, and to complete consent forms.
Those who agreed to participate were visited in their own homes and again had the opportunity to ask questions about the study before being asked to complete consent forms.
Upon receiving the completed consent form and baseline survey, an independent research assistant randomises families to either the behavioural sleep intervention group or the control group of 'usual care'.
Prior to participation, participants completed consent forms and a personal information sheet on which they indicated their ethnic origin.
Participants completed consent forms and were paid.
These participants completed consent forms and demographic forms prior to beginning the telephone interviews.
Study staff will collect and review completed consent forms from the teachers.
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