Recruiting to Clinical Trials on the Telephone

Phase 3

Completed

• Conditions: Vaccination; Newborn; Parental Consent
• Interventions: Behavioral: consultation face-to-face; Behavioral: telephone

• Registration Number: NCT02570061
• Lead Sponsor: Gorm Greisen

Brief 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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Study First Posted: 2015-10-07
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
face-to-face	consultation face-to-face	Information about the Calmette study was given face-to-face at a consultation at the hospital
telephone	telephone	Information about the Calmette study was given by telephone

Primary Outcome Measures

Name	Time	Method
total communication score	2 weeks after information was given	Sum of scores of answers to all questions in a proprietary questionnaire

Secondary Outcome Measures

Name	Time	Method
satisfaction subscore	2.5 months after birth of the infant	satisfaction with information process: sum of scores of answers
comprehension subscore	2.5 months after birth of the infant	comprehension of trial-related information: sum of scores of answers