Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-20 @ 12:42 PM
Study NCT ID:
NCT00846066
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Health Training Program for Pediatric Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ntalib@cmh.edu', 'phone': '816-234-3242', 'title': 'Nasreen Talib MD, MPH.', 'organization': 'Childrens Mercy Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Total number of Participants Risk is 0. This is because serious and other non serious adverse events were not collected or assessed. This was an educational intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Web Based Training Only (WBT)', 'description': 'This group received only the web based training prior to randomization(control group)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'WBT Plus Hands on Training (HOT)', 'description': 'This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percentage of Correct Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WBT Only', 'description': 'Control Group Web Based Training only'}, {'id': 'OG001', 'title': 'WBT+HOT', 'description': 'Web Based Training plus Hands on Training'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '27', 'groupId': 'OG000'}, {'value': '87', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after Hands-on Training (HOT)', 'description': 'Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups', 'unitOfMeasure': 'Percentage of correct skills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Confidence at 4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WBT Only', 'description': 'Control Group Web Based Training only'}, {'id': 'OG001', 'title': 'WBT + HOT', 'description': 'Web Based Training plus Hands on Training'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '.33', 'groupId': 'OG000'}, {'value': '19', 'spread': '.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 months', 'description': 'Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} \\*100%', 'unitOfMeasure': 'Percent change.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only completed paired (pre/post intervention) surveys were analyzed'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WBT Only', 'description': 'Control Group Web Based Training only'}, {'id': 'OG001', 'title': 'WBT+HOT', 'description': 'Web Based Training plus Hands on Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-11', 'spread': '.33', 'groupId': 'OG000'}, {'value': '-33', 'spread': '.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 months', 'description': 'Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} \\*100%', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WBT Only', 'description': 'Control Group Web Based Training only'}, {'id': 'OG001', 'title': 'WBT+HOT', 'description': 'Web Based Training plus Hands on Training'}], 'classes': [{'categories': [{'measurements': [{'value': '26.32', 'spread': '13.25', 'groupId': 'OG000'}, {'value': '36.67', 'spread': '22.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 6 months', 'description': 'The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}\\*100%', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Web Based Training Only (WBT)', 'description': 'This group received only the web based training prior to randomization(control group)'}, {'id': 'FG001', 'title': 'WBT Plus Hands on Training (HOT)', 'description': 'This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "All Pediatric residents, in the Continuity Clinic Rotation (CCC) at a general pediatric ambulatory clinic, in an urban tertiary care children's hospital, were invited to participate. Residents in any year of training were considered eligible for the study, recruitment took place in January, 2007", 'preAssignmentDetails': '59 participants were evaluated for the pre-test knowledge, they were next administered the Web Based Training and were then evaluated for the post-test knowledge. 56 participants were then randomized into two groups, 3 were excluded, (2 refused consent and 1 deviated from the protocol).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'WBT Only', 'description': 'Control Group Web Based Training only'}, {'id': 'BG001', 'title': 'WBT+HOT', 'description': 'Web Based Training plus Hands on Training'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Level of Training', 'classes': [{'title': 'First year Residents', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Second and Third year Residents', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The level of training during residency,', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2009-02-13', 'resultsFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-21', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percentage of Correct Skills', 'timeFrame': '3 months after Hands-on Training (HOT)', 'description': 'Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups'}, {'measure': 'Percent Change From Baseline in Confidence at 4 Months', 'timeFrame': 'Baseline and 4 months', 'description': 'Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} \\*100%'}, {'measure': 'Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months', 'timeFrame': 'Baseline and 4 months', 'description': 'Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} \\*100%'}, {'measure': 'Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months', 'timeFrame': 'At baseline and 6 months', 'description': 'The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}\\*100%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['educational research,', 'instructional methods,', 'Hands on training,', 'Web based training,', 'pediatric residents', 'preventive oral health,', 'dental caries,', 'Instructional strategies in Preventive Oral health', 'Web-based training on Preventive Oral Health', 'Hands on Training on Preventive Oral Health'], 'conditions': ['Preventive Oral Health']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.', 'detailedDescription': "Objectives:\n\nTo compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .\n\nMethods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPediatric Residents in the Continuity Care Clinics at Children's Mercy Hospital during the months of January and February 2007\n\nExclusion Criteria:\n\n1. Residents on leave of absence\n2. Residents who have their Continuity Care Clinics off site\n3. Residents refusing consent for inclusion of results in study"}, 'identificationModule': {'nctId': 'NCT00846066', 'briefTitle': 'Oral Health Training Program for Pediatric Residents', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Effective Educational Instruction in Preventive Oral Health: Hands On Training (HOT)Versus Web Based Training (WBT): A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB# 06 10-150E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hands on Training', 'description': 'Hands on Training by a pediatric dentist', 'interventionNames': ['Other: Hands on training', 'Other: Web based training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Web Based Training', 'description': 'Web Based Training for all residents before randomization', 'interventionNames': ['Other: Web based training']}], 'interventions': [{'name': 'Hands on training', 'type': 'OTHER', 'otherNames': ['Active educational training with a pediatric dentist'], 'description': 'Hands on training by a pediatric dentist on preventive oral health', 'armGroupLabels': ['Hands on Training']}, {'name': 'Web based training', 'type': 'OTHER', 'otherNames': ['Educational Web Based Training for all residents'], 'description': 'Web based training alone', 'armGroupLabels': ['Hands on Training', 'Web Based Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Childrens Mercy Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Nasreen J Talib, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatrician', 'investigatorFullName': 'Nasreen Talib', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}