Parental ConsentPhase 3NCT02570061
Recruiting to Clinical Trials on the Telephone
A Phase 3 study testing telephone and consultation face-to-face in people with Parental Consent and Newborn, run by Gorm Greisen.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parental Consent, Newborn, Vaccination
- What is being tested?
- telephone and consultation face-to-face
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Planning to give birth at Rigshospitalet
Who cannot join
- Prior contact to the Calmette trial staff
- Unable/unwilling to come to hospital for face-to-face information
- Declining participation in this trial
About this study
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.
Read the 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.
- Conditions
- Parental Consent, Newborn, Vaccination
- Being tested
- telephone, consultation face-to-face
- Keywords
- recruitment, comprehension, satisfaction, informed consent, telephone
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephoneBehavioural
information given at the primary contact by phone, or at a scheduled later time
consultation face-to-faceBehavioural
information given at a scheduled consultation at the hospital
| Study group | Role | What they receive |
|---|---|---|
| telephone | Experimental | Information about the Calmette study was given by telephone Receives: Behavioral: telephone |
| face-to-face | Active comparator | Information about the Calmette study was given face-to-face at a consultation at the hospital Receives: Behavioral: consultation face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
total communication score
Sum of scores of answers to all questions in a proprietary questionnaire
Measured: 2 weeks after information was given
Secondary outcomes (4)
comprehension subscore
comprehension of trial-related information: sum of scores of answers
Measured: 2 weeks after information was given
satisfaction subscore
satisfaction with information process: sum of scores of answers
Measured: 2 weeks after information was given
comprehension subscore
comprehension of trial-related information: sum of scores of answers
Measured: 2.5 months after birth of the infant
satisfaction subscore
satisfaction with information process: sum of scores of answers
Measured: 2.5 months after birth of the infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parental ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gorm Greisen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kim Foss, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570061
- Sponsor's protocol ID
- H-4-2013 FSP-044
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25896113Foss 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.
PubMed 27871308
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruiting to Clinical Trials on the Telephone
- ClinicalTrials.gov ID
- NCT02570061
- Acronym / sponsor ID
- H-4-2013 FSP-044
- Conditions
- Parental Consent, Newborn, Vaccination
- Keywords
- recruitment, comprehension, satisfaction, informed consent, telephone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Gorm GreisenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone | Experimental | Behavioral: telephoneInformation about the Calmette study was given by telephone |
| face-to-face | Active comparator | Behavioral: consultation face-to-faceInformation about the Calmette study was given face-to-face at a consultation at the hospital |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Planning to give birth at Rigshospitalet
Key exclusion criteria (3 listed)
- Prior contact to the Calmette trial staff
- Unable/unwilling to come to hospital for face-to-face information
- Declining participation in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephoneinformation given at the primary contact by phone, or at a scheduled later time | Behavioural | telephone |
| consultation face-to-faceinformation given at a scheduled consultation at the hospital | Behavioural | face-to-face |
Primary outcome
total communication score
Time frame: 2 weeks after information was given
Sum of scores of answers to all questions in a proprietary questionnaire
4 secondary outcomes
comprehension subscore
Time frame: 2 weeks after information was given
satisfaction subscore
Time frame: 2 weeks after information was given
comprehension subscore
Time frame: 2.5 months after birth of the infant
satisfaction subscore
Time frame: 2.5 months after birth of the infant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- Background: PubMed 25896113Thostesen 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.
- Derived from this study: PubMed 27871308Foss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Foss, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telephone and consultation face-to-face in people with Parental Consent and Newborn, run by Gorm Greisen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total communication score (time frame: 2 weeks after information was given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.