Recruiting to Clinical Trials on the Telephone

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recruiting to Clinical Trials on the Telephone

Conditions
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Parental Consent, Newborn, Vaccination

Intervention / Treatment
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* Behavioral: telephone
* Behavioral: consultation face-to-face


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recruitment, comprehension, satisfaction, informed consent, telephone