Recruiting to Clinical Trials on the Telephone

Vaccination Clinical Trial

Official title:

Recruiting to Clinical Trials on the Telephone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570061
• Other study ID #: H-4-2013 FSP-044
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2015
• Last updated: October 6, 2015
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Newborn
• Parental Consent
• Vaccination

Intervention

Behavioral:
• telephone
information given at the primary contact by phone, or at a scheduled later time
• consultation face-to-face
information given at a scheduled consultation at the hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gorm Greisen

References & Publications (1)

Thøstesen LM, Nissen TN, Kjærgaard J, Pihl GT, Birk NM, Benn CS, Greisen G, Kofoed PE, Pryds O, Ravn H, Jeppesen DL, Aaby P, Stensballe LG. Bacillus Calmette-Guérin immunisation at birth and morbidity among Danish children: A prospective, randomised, clinical trial. Contemp Clin Trials. 2015 May;42:213-8. doi: 10.1016/j.cct.2015.04.006. Epub 2015 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total communication score	Sum of scores of answers to all questions in a proprietary questionnaire	2 weeks after information was given	Yes
Secondary	comprehension subscore	comprehension of trial-related information: sum of scores of answers	2 weeks after information was given	Yes
Secondary	satisfaction subscore	satisfaction with information process: sum of scores of answers	2 weeks after information was given	No
Secondary	comprehension subscore	comprehension of trial-related information: sum of scores of answers	2.5 months after birth of the infant	Yes
Secondary	satisfaction subscore	satisfaction with information process: sum of scores of answers	2.5 months after birth of the infant	No