Recruiting to Clinical Trials on the Telephone
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Parental Consent
- Sponsor
- Gorm Greisen
- Enrollment
- 125
- Primary Endpoint
- total communication score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Gorm Greisen
consultant, professor
Rigshospitalet, Denmark
Eligibility Criteria
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
Outcomes
Primary Outcomes
total communication score
Time Frame: 2 weeks after information was given
Sum of scores of answers to all questions in a proprietary questionnaire
Secondary Outcomes
- satisfaction subscore(2.5 months after birth of the infant)
- comprehension subscore(2.5 months after birth of the infant)