Recruiting to Clinical Trials on the Telephone

NCT02570061 | Completed Phase 3

• 1 other identifier: H-4-2013 FSP-044
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parental Consent; Newborn; Vaccination

Keywords

recruitment; comprehension; satisfaction; informed consent; telephone

Outcome Measures

Primary Outcomes (1)

• total communication score

  Sum of scores of answers to all questions in a proprietary questionnaire

  2 weeks after information was given

Secondary Outcomes (4)

• comprehension subscore

  2 weeks after information was given

• satisfaction subscore

  2 weeks after information was given

• comprehension subscore

  2.5 months after birth of the infant

• satisfaction subscore

  2.5 months after birth of the infant

Study Arms (2)

telephone

EXPERIMENTAL

Information about the Calmette study was given by telephone

Behavioral: telephone

face-to-face

ACTIVE COMPARATOR

Information about the Calmette study was given face-to-face at a consultation at the hospital

Behavioral: consultation face-to-face

Interventions

telephone BEHAVIORAL

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

telephone

consultation face-to-face BEHAVIORAL

information given at a scheduled consultation at the hospital

face-to-face

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning to give birth at Rigshospitalet

You may not qualify if:

• Prior contact to the Calmette trial staff
• Unable/unwilling to come to hospital for face-to-face information
• Declining participation in this trial

Sponsors & Collaborators

• Gorm Greisen: lead

Related Publications (2)

• 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.

  PMID: 25896113 BACKGROUND

• 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.

  PMID: 27871308 DERIVED

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kim Foss, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant, professor

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10