Vaccination Clinical Trial
Official title:
Recruiting to Clinical Trials on the Telephone
This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers who were contacted for participation in a vaccination trial (the Calmette study, NCT01694108) were randomized to receive information by telephone or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about the study and satisfaction with the information process. The outcome was measured using a questionnaire two weeks after the information was provided and two and a half months after birth.
Informed consent is an essential element of clinical research. Obtaining consent, however,
may be challenging. The use of the telephone for giving information and obtaining consent
may be practical but little formal research has been done.
This study examined the use of the telephone for the purpose of informing expectant mothers
about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.
Expectant mothers who were contacted for participation in the Calmette Study were randomised
to receive information by telephone or at a face-to-face consultation. The primary outcome
was a communication score, consisting of comprehension of information about the study and
satisfaction with the information process. The outcome was measured using a questionnaire
two days after the information was provided and two and a half months after birth.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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