Clinical trial NCT02570061: Recruiting to Clinical Trials on the Telephone
Official title: Recruiting to Clinical Trials on the Telephone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parental Consent
Newborn
Vaccination
Keywords: recruitment
comprehension
satisfaction
informed consent
telephone
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 125
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: total communication score
timeFrame: 2 weeks after information was given
Secondary outcomes:
measure: comprehension subscore
timeFrame: 2 weeks after information was given
measure: satisfaction subscore
timeFrame: 2 weeks after information was given
measure: comprehension subscore
timeFrame: 2.5 months after birth of the infant
measure: satisfaction subscore
timeFrame: 2.5 months after birth of the infant
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kim Foss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thostesen LM, Nissen TN, Kjaergaard J, Pihl GT, Birk NM, Benn CS, Greisen G, Kofoed PE, Pryds O, Ravn H, Jeppesen DL, Aaby P, Stensballe LG. Bacillus Calmette-Guerin 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.
citation: Foss KT, Kjaergaard J, Stensballe LG, Greisen G. Recruiting to Clinical Trials on the Telephone - a randomized controlled trial. Trials. 2016 Nov 21;17(1):552. doi: 10.1186/s13063-016-1680-y.