Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 8:19 AM
Study NCT ID:
NCT03798756
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Automated Check-in Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.a.lawton@keele.ac.uk', 'phone': '01782 734887', 'title': 'Mrs Sarah Lawton', 'organization': 'Keele University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort', 'description': 'All those patients checking-in for a pre-booked consultation using an automated check-in screen and answering at least one research question', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bodily Pain', 'description': 'To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '2937', 'groupId': 'OG000'}]}, {'title': 'Very mild', 'measurements': [{'value': '1061', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '1446', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '2344', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '1125', 'groupId': 'OG000'}]}, {'title': 'Very Severe', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '352', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bodily Pain Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort', 'description': 'Automated check-in'}], 'classes': [{'categories': [{'measurements': [{'value': '8922', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'Proportion of participants answering the bodily pain research question using an automated check-in screen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Consent to Contact Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bodily Pain', 'description': 'To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '8285', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'Proportion of participants answering the consent to contact research question using an automated check-in screen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort', 'description': 'Automated check-in'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9274'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9274'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort', 'description': 'This was a Cohort, there were no arms. It was an entire group.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5982', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3292', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5653', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3621', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9274', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Patients checking in for a consultation, answering a research question, using check-in sceen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9274', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9274', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-05', 'size': 569707, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-22T12:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9274}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2018-09-14', 'resultsFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-23', 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported Bodily Pain', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.'}], 'secondaryOutcomes': [{'measure': 'Bodily Pain Response', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'Proportion of participants answering the bodily pain research question using an automated check-in screen.'}, {'measure': 'Consent to Contact Response', 'timeFrame': 'Through study completion at 1st visit (Day 1)', 'description': 'Proportion of participants answering the consent to contact research question using an automated check-in screen.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Care']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.', 'detailedDescription': 'The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. Participants will be recruited over three weeks from approximately 11 participating general practices.\n\nThe primary objective of the study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen. This will be measured by observing the percentage of completed automated check-in screens with entered research data.\n\nSecondary objectives will assess check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of age 18 and over, who can read and respond in English and with a booked appointment, consulting with any Health Care Professional (HCP) at their general practice, during the recruitment period will be eligible to participate. All patients are required to confirm their attendance at the general practice by using the automated check-in screen. If the patient completing the automated check-in screen is 18 years of age or over, the additional two research questions will appear for completion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or over attending participating general practices for a consultation with any healthcare professional.\n* Patients registered with the participating general practice during the specified recruitment period.\n* Patients able to read and respond in English.\n\nExclusion Criteria:\n\n• Patients under the age of 18 attending the general practice for a consultation with a healthcare professional.'}, 'identificationModule': {'nctId': 'NCT03798756', 'acronym': 'ACDC', 'briefTitle': 'Automated Check-in Data Collection Study', 'organization': {'class': 'OTHER', 'fullName': 'Keele University'}, 'officialTitle': 'Automated Check-in Data Collection Study', 'orgStudyIdInfo': {'id': 'RG-0275-18 V1.0'}}, 'contactsLocationsModule': {'locations': [{'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Christian D Mallen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Keele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keele University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}