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Completed

NCT Number: NCT02570061

Recruiting to Clinical Trials on the Telephone

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.

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Key information

Conditions

Parental Consent Behavior Newborn Personal Satisfaction Vaccination

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone

Behavioral

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

consultation face-to-face

Behavioral

information given at a scheduled consultation at the hospital

Primary outcomes

  1. total communication score

    Time frame: 2 weeks after information was given

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

Secondary outcomes

  1. comprehension subscore

    Time frame: 2 weeks after information was given

    comprehension of trial-related information: sum of scores of answers

  2. satisfaction subscore

    Time frame: 2 weeks after information was given

    satisfaction with information process: sum of scores of answers

  3. comprehension subscore

    Time frame: 2.5 months after birth of the infant

    comprehension of trial-related information: sum of scores of answers

  4. satisfaction subscore

    Time frame: 2.5 months after birth of the infant

    satisfaction with information process: sum of scores of answers

Sponsors and collaborators

Lead sponsor

Gorm Greisen

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 7, 2015
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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