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Recruiting to Clinical Trials on the Telephone

NCT02570061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2015-10-07

No results posted yet for this study

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.

Conditions

  • Parental Consent
  • Newborn
  • Vaccination

Interventions

BEHAVIORAL

telephone

information given at the primary contact by phone, or at a scheduled later time

BEHAVIORAL

consultation face-to-face

information given at a scheduled consultation at the hospital

Sponsors & Collaborators

  • Gorm Greisen

    lead OTHER

Principal Investigators

  • Kim Foss, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-11-30
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570061 on ClinicalTrials.gov