Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02570061
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 3
Start date July 2013
Completion date February 2014

See also
  Status Clinical Trial Phase
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Recruiting NCT05996549 - Cost-effectiveness of the Influenza Vaccination Phase 4
Completed NCT04323137 - Encouraging Flu Vaccination Among High-Risk Patients Identified by ML N/A
Completed NCT01224301 - School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities N/A
Completed NCT00169858 - Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections Phase 4
Completed NCT05509283 - Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications N/A
Completed NCT02907580 - Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric N/A
Recruiting NCT06160999 - Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia N/A
Recruiting NCT03875703 - Post-Vaccination Biological Collection
Completed NCT03287830 - Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine N/A
Completed NCT02907645 - Influenza Vaccine Randomized Educational Trial: Adult N/A
Completed NCT03220555 - Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center N/A
Withdrawn NCT05023512 - Understanding Public Attitudes Towards the COVID-19 Vaccination N/A
Recruiting NCT02937428 - To Look or Not to Look at the Needle During Vaccination Phase 3
Completed NCT00813319 - Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females Phase 3
Completed NCT03104790 - Assessment of Viral Shedding in Children Previously in Receipt of Multiple Doses of Live Attenuated Influenza Vaccine (LAIV) Compared to Influenza Vaccine-naïve Controls Phase 4
Completed NCT04780867 - Psychological and Lifestyle Factors on Health Outcomes N/A
Completed NCT03239795 - Promoting Influenza Vaccination In General Practice Waiting Rooms N/A