Newborn, Parental Consent, Vaccination
Conditions
Keywords
recruitment, comprehension, satisfaction, informed consent, telephone
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.
Interventions
BEHAVIORALtelephone
information given at the primary contact by phone, or at a scheduled later time
BEHAVIORALconsultation face-to-face
information given at a scheduled consultation at the hospital
Sponsors
Gorm Greisen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total communication score | 2 weeks after information was given | Sum of scores of answers to all questions in a proprietary questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comprehension subscore | 2 weeks after information was given | comprehension of trial-related information: sum of scores of answers |
| satisfaction subscore | 2 weeks after information was given | satisfaction with information process: sum of scores of answers |
Outcome results
None listed