Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 3:43 AM
Study NCT ID:
NCT01676532
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study on the Model School Pediatric Health Initiative Pilot Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'freemansl@smh.ca', 'phone': '416-864-6060', 'title': 'Sloane Freeman', 'phoneExt': '77042', 'organization': "St.Michael's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'no adverse events were reported for students attending SBHC', 'eventGroups': [{'id': 'EG000', 'title': 'Students Attending SBHC', 'description': 'Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.', 'otherNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Enrolled Participants Who Attended SBHC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Students Attending SBHC', 'description': 'Students who were enrolled at the SBHC and then attended the SBHC'}], 'classes': [{'title': 'Total number of students attending SBHC', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}, {'title': 'Number of students not attending SBHC', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The primary objectives are to determine utilization of the SBHC including:\n\n1. The number of students who are enrolled at the SBHC\n2. The number of enrolled students enrolled who attended the SBHC', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.'}, {'type': 'SECONDARY', 'title': 'Number of Students Attending SBHC With New Treatment Plans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Students Attending SBHC With New Treatment Plans', 'description': 'The total number of students who attended SBHC that had new treatment plans proposed'}], 'classes': [{'title': 'Number of students with treatment plans', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Number of students with no treatment plans', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Proportion of children seen in the clinic with treatment plans', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '115 students out of 127 students attending SBHC had a new treatment plan.'}, {'type': 'SECONDARY', 'title': 'Number of Students Attending SBHC With New Diagnoses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Students Attending SBHC With New Diagnoses', 'description': 'Porportion of students attending SBHC with new diagnoses'}], 'classes': [{'title': 'Number of students attending SBHC_ new diagnosis', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Number of students attending SBHC with >1 new diag', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'No new diagnosis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of students attending SBHC with new diagnoses', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis'}, {'type': 'SECONDARY', 'title': 'Number of Referrals Made of Students Attending SBHC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Referrals Made for Students Attending SBHC', 'description': 'Types and number of referrals made for students attending SBHC.'}], 'classes': [{'title': 'Number of students with no referrals', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred to family physician', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred to specialist', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred for psychological test', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'number of students ref to community mental health', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred to dietician', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred to audiology testing', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'number of students referred to vision testing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Students From Sprucecourt Who Enrolled in SBHC', 'description': 'From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 months', 'description': 'The number of students who enrolled in SBHC who were from the host school Sprucecourt', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sprucecourt Public School Vs Other Participating Schools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprucecourt Public School Vs Other Participating Schools', 'description': 'The number of students from the host school of the SBHC and other participating schools'}], 'classes': [{'title': 'number of students attending from Sprucecourt', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'number of students attending from school cluster', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'number of students attending from preschool age', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'number of students with unknown enrolment data', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 months', 'description': 'To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'total number of students who attended SBHC'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Students Triaged From School Support Team Meetings', 'timeFrame': '1 year', 'description': 'The number of students triaged from SST meetings was not collected.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Students Referred to SBHC Who Attended SBHC', 'timeFrame': '8 months', 'description': 'This data was not collected.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Follow-up Appointments', 'timeFrame': '1 year', 'description': 'Attendance at follow-up appoints was not collected.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absenteeism', 'timeFrame': '1 year', 'description': 'Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ontario Health Insurance Plan (OHIP)Status', 'timeFrame': '1 year', 'description': 'OHIP status of students attending the clinic was not reported or collected', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Students Attending SBHC', 'description': 'Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Students Attending SBHC', 'description': 'Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.\n\nStudents attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Retrospective chart review', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2012-08-21', 'resultsFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-15', 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)', 'timeFrame': '8 months', 'description': 'The number of students who enrolled in SBHC who were from the host school Sprucecourt'}, {'measure': 'Sprucecourt Public School Vs Other Participating Schools', 'timeFrame': '8 months', 'description': 'To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools'}, {'measure': 'Number of Students Triaged From School Support Team Meetings', 'timeFrame': '1 year', 'description': 'The number of students triaged from SST meetings was not collected.'}, {'measure': 'Number of Students Referred to SBHC Who Attended SBHC', 'timeFrame': '8 months', 'description': 'This data was not collected.'}, {'measure': 'Follow-up Appointments', 'timeFrame': '1 year', 'description': 'Attendance at follow-up appoints was not collected.'}, {'measure': 'Absenteeism', 'timeFrame': '1 year', 'description': 'Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected'}, {'measure': 'Ontario Health Insurance Plan (OHIP)Status', 'timeFrame': '1 year', 'description': 'OHIP status of students attending the clinic was not reported or collected'}], 'primaryOutcomes': [{'measure': 'Number of Enrolled Participants Who Attended SBHC', 'timeFrame': '1 year', 'description': 'The primary objectives are to determine utilization of the SBHC including:\n\n1. The number of students who are enrolled at the SBHC\n2. The number of enrolled students enrolled who attended the SBHC'}], 'secondaryOutcomes': [{'measure': 'Number of Students Attending SBHC With New Treatment Plans', 'timeFrame': '1 year', 'description': 'Proportion of children seen in the clinic with treatment plans'}, {'measure': 'Number of Students Attending SBHC With New Diagnoses', 'timeFrame': '1 year', 'description': 'Number of students attending SBHC with new diagnoses'}, {'measure': 'Number of Referrals Made of Students Attending SBHC', 'timeFrame': '1 year', 'description': 'Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['School Board Health Center', 'Pediatrics'], 'conditions': ['School Board Health Centers']}, 'descriptionModule': {'briefSummary': 'This is a prospective cross sectional study to assess the feasibility of a school based health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in Toronto. The SBHC allows inner-city children who face barriers to accessing health care the opportunity to receive health care in their school.The primary aim of this study is to determine utilization of the SBHC. Establishing feasibility of the SBHC would support further development and expansion of this program into other inner city schools.', 'detailedDescription': 'A chart review of the first year of the SBHC was conducted. Feasibility metrics included the number of children who enrolled at the SBHC. Efficacy metrics included the proportion of enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled children who attended and received new diagnoses and treatment plans'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All students of Sprucecourt Public School as well as the fourteen surrounding inner city public schools and their siblings. All children attending the on-site Parenting and Family Literacy Centre.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All students at Sprucecourt Public School and the surrounding fourteen schools, as well as their siblings (ages 0-12 years), who are enrolled at and have consent to attend the SBHC\n* All infants and preschool aged children attending the on-site Parenting and Family Literacy Centre who are enrolled at the SBHC\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01676532', 'briefTitle': 'Feasibility Study on the Model School Pediatric Health Initiative Pilot Project', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Feasibility Study on the Model School Pediatric Health Initiative Pilot Project', 'orgStudyIdInfo': {'id': '1000025631'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Students attending SBHC', 'description': 'Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.', 'interventionNames': ['Other: Students attending SBHC']}], 'interventions': [{'name': 'Students attending SBHC', 'type': 'OTHER', 'description': 'School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC', 'armGroupLabels': ['Students attending SBHC']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jonathon Maguire, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Jonathon Maguire', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}