Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-09 @ 11:29 AM
Study NCT ID:
NCT05871450
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2023-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Legacy of the Special Olympics World Games Berlin 2023
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083644', 'term': 'Social Inclusion'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wolfgang.ruf@dhgs-hochschule.de', 'phone': '+49 (030) 577 97 37 370', 'title': 'Wolfgang Ruf', 'organization': 'German University of Health and Sports'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not monitored', 'description': 'Adverse events were not monitored in this study because the intervention was non-invasive, low-risk, and behavioral in nature, involving only questionnaire-based assessments and/or educational or social interaction components. Based on prior literature and ethical review, the likelihood of physical or psychological harm was deemed minimal. Therefore, systematic tracking of adverse events was not considered necessary for this study design.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Living in Host Towns', 'description': 'Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants Not Living in Host Towns', 'description': 'Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attitudes Measured With the ATTID-Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Living in Host Towns', 'description': 'Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events.'}, {'id': 'OG001', 'title': 'Participants Not Living in Host Towns', 'description': 'Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator.'}], 'classes': [{'title': 'T1 Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'T1 Knowledge of capacity and rights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'T1 Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.22', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'T1 Sensitivity or tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'T1 Knowledge of causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'T2 Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'T2 Knowledge of capacity and rights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'T2 Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.21', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'T2 Sensitivity or tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'T2 Knowledge of causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'T3 Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'T3 knowledge of capacity and rights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.84', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'T3 Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.22', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'T3 Sensitivity and tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'T3 knowledge of causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline (T1) attitudes toward people with intellectual disability (ATTID-Questionnaire) at 3-4 month (T2) and 8-9 month (T3)', 'description': "The ATTID-SF Questionnaire encompassing three core components. The affective component refers to emotional responses toward individuals with intellectual disabilities. The cognitive component encompasses beliefs, knowledge, and perceptions about this population. The behavioral component reflects self-reported actions. The short form comprises 35 items rated on a 5-point Likert scale (1 = strongly agree to 5 = strongly disagree), with higher scores indicating more negative attitudes. Items are grouped into five factors: (1) interaction, (2) sensitivity/tenderness, (3) discomfort, (4) knowledge about abilities, and (5) knowledge about causes of intellectual disabilities. Mean scores are calculated for each factor; however, due to the scale's factor structure, an overall score is not recommended. So the minimum mean score for each factor is 1, the maximum means score is 5.", 'unitOfMeasure': 'mean change score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference is due to dropouts during the follow-up assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Living in Host Towns', 'description': 'Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events.'}, {'id': 'FG001', 'title': 'Participants Not Living in Host Towns', 'description': 'Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '76'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Living in Host Towns', 'description': 'Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events.'}, {'id': 'BG001', 'title': 'Participants Not Living in Host Towns', 'description': 'Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '487', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'because participants did not provide any information'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'beca', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'because participants did not provide any information'}, {'title': 'physical activity with people with intellectual disabilities', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Percentage of people who reported beeing physically active together with people with intellectual disabilities.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'work with people with intellectual disabilities', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Percentage of people who stated that they work with people with intellectual disabilities.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'this is the toal number of participants. The difference is because some participants did not provide any information at baseline measurement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-03', 'size': 160596, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-25T04:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2023-05-04', 'resultsFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-27', 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attitudes Measured With the ATTID-Questionnaire', 'timeFrame': 'Change from baseline (T1) attitudes toward people with intellectual disability (ATTID-Questionnaire) at 3-4 month (T2) and 8-9 month (T3)', 'description': "The ATTID-SF Questionnaire encompassing three core components. The affective component refers to emotional responses toward individuals with intellectual disabilities. The cognitive component encompasses beliefs, knowledge, and perceptions about this population. The behavioral component reflects self-reported actions. The short form comprises 35 items rated on a 5-point Likert scale (1 = strongly agree to 5 = strongly disagree), with higher scores indicating more negative attitudes. Items are grouped into five factors: (1) interaction, (2) sensitivity/tenderness, (3) discomfort, (4) knowledge about abilities, and (5) knowledge about causes of intellectual disabilities. Mean scores are calculated for each factor; however, due to the scale's factor structure, an overall score is not recommended. So the minimum mean score for each factor is 1, the maximum means score is 5."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inclusion, Social']}, 'descriptionModule': {'briefSummary': 'This research aims to evaluate the impact of the project "170 Nations - 170 Inclusive Communities" of the Special Olympics World Games 2023 (SOWG 23) on sustain inclusive structures for people with intellectual disabilities (ID). The research utilizes a quasi-experimental research design and a qualitative research design and will synthesize qualitative and quantitative data to display successful and non-successful interventions for more inclusive communities. The research will target 56 host communities of SOWG 23 and 56 non-host communities, interviewing 200 people with ID and a minimum of 400 key stakeholders, as well as conducting qualitative interviews and focus groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* legal age\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05871450', 'briefTitle': 'Legacy of the Special Olympics World Games Berlin 2023', 'organization': {'class': 'OTHER', 'fullName': 'German University of Health and Sports'}, 'officialTitle': 'Legacy of the Special Olympics World Games Berlin 2023', 'orgStudyIdInfo': {'id': 'SOWG Studie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants living in Host Towns', 'description': 'Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events.', 'interventionNames': ['Behavioral: Inclusive events']}, {'type': 'NO_INTERVENTION', 'label': 'Participants not living in Host Towns', 'description': 'Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator.'}], 'interventions': [{'name': 'Inclusive events', 'type': 'BEHAVIORAL', 'description': 'Inclusive events such as inclusive sport festivals, citizen festivals or working groups at school are organized', 'armGroupLabels': ['Participants living in Host Towns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10587', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German University of Health and Sport', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Wolfgang Ruf, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'German University of Health and Sports'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German University of Health and Sports', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}