Recruiting to Clinical Trials on the Telephone

Gorm Greisen

Status and phase: Completed; Phase 3

Conditions: Vaccination; Newborn; Parental Consent

Treatments: Behavioral: telephone; Behavioral: consultation face-to-face

Study type: Interventional

Funder types: Other

Identifiers

NCT02570061

H-4-2013 FSP-044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Planning to give birth at Rigshospitalet

Exclusion criteria

• Prior contact to the Calmette trial staff
• Unable/unwilling to come to hospital for face-to-face information
• Declining participation in this trial

Trial design

125 participants in 2 patient groups

telephone

Experimental group

Description:

Information about the Calmette study was given by telephone

Treatment:

Behavioral: telephone

face-to-face

Active Comparator group

Description:

Information about the Calmette study was given face-to-face at a consultation at the hospital

Treatment:

Behavioral: consultation face-to-face