Recruiting to Clinical Trials on the Telephone

October 6, 2015 updated by: Gorm Greisen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telephone
Information about the Calmette study was given by telephone
Behavioral: telephone
information given at the primary contact by phone, or at a scheduled later time
Active Comparator: face-to-face
Information about the Calmette study was given face-to-face at a consultation at the hospital
Behavioral: consultation face-to-face
information given at a scheduled consultation at the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total communication score
Time Frame: 2 weeks after information was given
Sum of scores of answers to all questions in a proprietary questionnaire
2 weeks after information was given

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comprehension subscore
Time Frame: 2 weeks after information was given
comprehension of trial-related information: sum of scores of answers
2 weeks after information was given
satisfaction subscore
Time Frame: 2 weeks after information was given
satisfaction with information process: sum of scores of answers
2 weeks after information was given
comprehension subscore
Time Frame: 2.5 months after birth of the infant
comprehension of trial-related information: sum of scores of answers
2.5 months after birth of the infant
satisfaction subscore
Time Frame: 2.5 months after birth of the infant
satisfaction with information process: sum of scores of answers
2.5 months after birth of the infant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gorm Greisen

Investigators

  • Principal Investigator: Kim Foss, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-4-2013 FSP-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newborn

Clinical Trials on telephone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe