Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02570061
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recruiting to Clinical Trials on the Telephone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total communication score', 'timeFrame': '2 weeks after information was given', 'description': 'Sum of scores of answers to all questions in a proprietary questionnaire'}], 'secondaryOutcomes': [{'measure': 'comprehension subscore', 'timeFrame': '2 weeks after information was given', 'description': 'comprehension of trial-related information: sum of scores of answers'}, {'measure': 'satisfaction subscore', 'timeFrame': '2 weeks after information was given', 'description': 'satisfaction with information process: sum of scores of answers'}, {'measure': 'comprehension subscore', 'timeFrame': '2.5 months after birth of the infant', 'description': 'comprehension of trial-related information: sum of scores of answers'}, {'measure': 'satisfaction subscore', 'timeFrame': '2.5 months after birth of the infant', 'description': 'satisfaction with information process: sum of scores of answers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recruitment', 'comprehension', 'satisfaction', 'informed consent', 'telephone'], 'conditions': ['Parental Consent', 'Newborn', 'Vaccination']}, 'referencesModule': {'references': [{'pmid': '25896113', 'type': 'BACKGROUND', 'citation': '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': '27871308', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to give birth at Rigshospitalet\n\nExclusion Criteria:\n\n* Prior contact to the Calmette trial staff\n* Unable/unwilling to come to hospital for face-to-face information\n* Declining participation in this trial'}, 'identificationModule': {'nctId': 'NCT02570061', 'briefTitle': 'Recruiting to Clinical Trials on the Telephone', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Recruiting to Clinical Trials on the Telephone', 'orgStudyIdInfo': {'id': 'H-4-2013 FSP-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telephone', 'description': 'Information about the Calmette study was given by telephone', 'interventionNames': ['Behavioral: telephone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'face-to-face', 'description': 'Information about the Calmette study was given face-to-face at a consultation at the hospital', 'interventionNames': ['Behavioral: consultation face-to-face']}], 'interventions': [{'name': 'telephone', 'type': 'BEHAVIORAL', 'description': 'information given at the primary contact by phone, or at a scheduled later time', 'armGroupLabels': ['telephone']}, {'name': 'consultation face-to-face', 'type': 'BEHAVIORAL', 'description': 'information given at a scheduled consultation at the hospital', 'armGroupLabels': ['face-to-face']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kim Foss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gorm Greisen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'consultant, professor', 'investigatorFullName': 'Gorm Greisen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}