NCT02570061

Recruiting to Clinical Trials on the Telephone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Gorm Greisen · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Parental Consent
• Newborn
• Vaccination

Interventions

Type	Name	Description
BEHAVIORAL	telephone	information given at the primary contact by phone, or at a scheduled later time
BEHAVIORAL	consultation face-to-face	information given at a scheduled consultation at the hospital

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2015-10-07
• Last updated: 2015-10-07