Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05552027
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Minnesota HealthSolutions Cellular Car Seat Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ODONALDM@chop.edu', 'phone': '267-499-4114', 'title': "Morgan O'Donald", 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'CCS System Enabled. There are no adverse events to record for this study group.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'CCS System Disabled. There are no adverse events to record for this study group.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Installation Errors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Scenario A', 'description': 'Sensor system enabled to provide feedback. Full seat installation.'}, {'id': 'OG001', 'title': 'Control - Scenario A', 'description': 'Sensor system disabled in order to not provide feedback. Full seat Installation.'}, {'id': 'OG002', 'title': 'Intervention - Scenario B', 'description': 'Sensor enabled to provide feedback. Harness straps left loose.'}, {'id': 'OG003', 'title': 'Control - Scenario B', 'description': 'Sensor system disabled in order to not provide feedback. Harness straps left loose.'}, {'id': 'OG004', 'title': 'Intervention - Scenario C', 'description': 'Sensor system enabled. Carseat left loose at the base.'}, {'id': 'OG005', 'title': 'Control - Scenario C', 'description': 'Sensor system disable to not provide feedback. Carseat left loose at the base.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.01', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.01', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Once during the only study visit: up to 30 mins', 'description': 'For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group were given a study phone and asked to use the CCS smartphone app to complete the scenarios, while the control group was given only the paper manual that came with the safety seat. The misuse scenarios included A) a full safety seat installation with the convertible seat beginning on the floor, B) loose harness straps, and C) loose attachment to the vehicle seat at the base.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.\n\nCCS System- Prototype: Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.\n\nCCS System- Control: The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.\n\nCCS System- Prototype: Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.\n\nCCS System- Control: The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).'}, {'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': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '59'}, {'value': '36', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '44'}, {'value': '36', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-07-20', 'size': 270926, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-03T14:42', 'hasProtocol': True}, {'date': '2022-06-06', 'size': 288341, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-03T14:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be randomly assigned to the intervention group or control group upon arrival at the study visit. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized control trial with 2 arms (intervention and control). The intervention group will participate in a series of three safety seat misuse scenarios with the CCS system enabled, and participants in the control group will participate in the same series of three safety seat misuse scenarios without the CCS system. Misuse scenarios include insecure attachment of the seat to the vehicle, incorrect harness straps, and improper orientation of the safety seat. In each scenario, participants will be asked to identify and correct each error. Each participant will be randomly assigned to either the control or intervention group. Each participant will receive the same scenarios in the same order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2022-08-05', 'resultsFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-23', 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Installation Errors', 'timeFrame': 'Once during the only study visit: up to 30 mins', 'description': 'For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Safety Seat Harness Tension']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. Ten leading causes of unintentional injury deaths, United States, 2016, all races, both sexes. https://webappa.cdc.gov/cgi-bin/broker.exe. Published 2016.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. Fatal Injury Data. https://www.cdc.gov/injury/wisqars/fatal.html. Accessed January 5, 2019.'}, {'type': 'BACKGROUND', 'citation': 'National Highway Traffic Safety Administration. Traffic Safety Facts 2008 Data: Young Drivers. Vol 2010. Washington, DC: US Department of Transportation; 2008. doi:DOT HS 811 169'}, {'type': 'BACKGROUND', 'citation': 'National SAFE KIDS Campaign and NHTSA Child Passenger Safety Technician Program Participant Manual. :C-4.'}, {'type': 'BACKGROUND', 'citation': 'Li HR, Pickrell TM, KC S. The 2015 National Survey of the Use of Booster Seats. Washington, DC; 2016. www.ntis.gov.'}, {'type': 'BACKGROUND', 'citation': 'Greenwell NK. Results of the National Child Restraint Use Special Study. Washington, DC; 2015. www.ntis.gov.'}, {'pmid': '12783914', 'type': 'BACKGROUND', 'citation': 'Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.'}, {'pmid': '15094411', 'type': 'BACKGROUND', 'citation': 'Arbogast KB, Durbin DR, Cornejo RA, Kallan MJ, Winston FK. An evaluation of the effectiveness of forward facing child restraint systems. Accid Anal Prev. 2004 Jul;36(4):585-9. doi: 10.1016/S0001-4575(03)00065-4.'}, {'type': 'BACKGROUND', 'citation': 'Brown J, Bilston L, McCaskill M. Injury implications of inappropriate use of adult seatbelt systems for children aged 2-8. Australas Road Res Polic Educ Conf. 2003;7(2):81-87.'}, {'pmid': '16737475', 'type': 'BACKGROUND', 'citation': 'Brown J, McCaskill ME, Henderson M, Bilston LE. Serious injury is associated with suboptimal restraint use in child motor vehicle occupants. J Paediatr Child Health. 2006 Jun;42(6):345-9. doi: 10.1111/j.1440-1754.2006.00870.x.'}, {'pmid': '12778394', 'type': 'BACKGROUND', 'citation': 'Lutz N, Arbogast KB, Cornejo RA, Winston FK, Durbin DR, Nance ML. Suboptimal restraint affects the pattern of abdominal injuries in children involved in motor vehicle crashes. J Pediatr Surg. 2003 Jun;38(6):919-23. doi: 10.1016/s0022-3468(03)00124-6.'}, {'pmid': '11956394', 'type': 'BACKGROUND', 'citation': 'Valent F, McGwin G Jr, Hardin W, Johnston C, Rue LW 3rd. Restraint use and injury patterns among children involved in motor vehicle collisions. J Trauma. 2002 Apr;52(4):745-51. doi: 10.1097/00005373-200204000-00023.'}, {'type': 'BACKGROUND', 'citation': 'Weinstein EB, Sweeney MM, Garber M, Eastwood MD, Osterman JG, Roberts JV. The Effect of Size Appropriate and Proper Restraint Use on Injury Severity of Children. In: 2nd Child Occupant Protection Symposium. Society of Automotive Engineers (SAE); 1997:181-186.'}, {'pmid': '10835054', 'type': 'BACKGROUND', 'citation': 'Winston FK, Durbin DR, Kallan MJ, Moll EK. The danger of premature graduation to seat belts for young children. Pediatrics. 2000 Jun;105(6):1179-83. doi: 10.1542/peds.105.6.1179.'}, {'type': 'BACKGROUND', 'citation': 'Decina LE, Lococo KH. Misuse of child restraints. 2004. http://icsw.nhtsa.gov/people/injury/research/misuse/images/misusescreen.pdf.'}, {'type': 'BACKGROUND', 'citation': 'Klinich KD, Manary MA, Flannagan CAC, et al. Labels, Instructions, and Features of Convertible Child Restraint Systems (CRS): Evaluating Their Effects on CRS Installation Errors. Washington, DC; 2010.'}, {'pmid': '12612241', 'type': 'BACKGROUND', 'citation': 'Wegner MV, Girasek DC. How readable are child safety seat installation instructions? Pediatrics. 2003 Mar;111(3):588-91. doi: 10.1542/peds.111.3.588.'}, {'type': 'BACKGROUND', 'citation': 'Doak CC, Doak LG, Root JH. Teaching Patients with Low Literacy Skills. 2nd ed. Philadelphia: JB Lippincott Co.; 1996.'}, {'type': 'BACKGROUND', 'citation': 'Participants Central. Prevent child heatsroke in cars. http://www.safercar.gov/participants/InandAroundtheCar/heatstroke.htm. Accessed December 7, 2016.'}, {'type': 'BACKGROUND', 'citation': 'Singh S, Stern S, Subramanian R. Not-in-Traffic Surveillance: Non-Crash Fatalities and Injuries.; 2015.'}, {'type': 'BACKGROUND', 'citation': 'Rudd R, Prasad A, Weston D, Wietholter K. Functional Assessment of Unattended Child Reminder Systems. Washington, DC; 2015.'}, {'type': 'BACKGROUND', 'citation': 'Null J. Heatsroke deaths of children in vehicles. https://noheatstroke.org/index.htm. Accessed January 5, 2019.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.', 'detailedDescription': 'The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or Females ages 18-75 years\n* Has harnessed/fastened a child into a car seat in the last five (5) years\n* Has a valid driver's license\n\nExclusion Criteria:\n\n* Non-fluency in written and/or spoken English\n* Participant cannot install a safety seat due to a physical or health limitation"}, 'identificationModule': {'nctId': 'NCT05552027', 'briefTitle': 'Minnesota HealthSolutions Cellular Car Seat Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Minnesota HealthSolutions'}, 'officialTitle': 'Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse', 'orgStudyIdInfo': {'id': '20-017790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.', 'interventionNames': ['Device: CCS System- Prototype']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.', 'interventionNames': ['Device: CCS System- Control']}], 'interventions': [{'name': 'CCS System- Prototype', 'type': 'DEVICE', 'description': 'Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)', 'armGroupLabels': ['Intervention']}, {'name': 'CCS System- Control', 'type': 'DEVICE', 'description': 'The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sara Seifert, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minnesota HealthSolutions'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': "The study will comply with CHOP's data retention policy (A-3-9). All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data", 'ipdSharing': 'YES', 'description': 'Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).', 'accessCriteria': 'IRB approval, data use agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minnesota HealthSolutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MPH', 'investigatorFullName': 'Sara Seifert', 'investigatorAffiliation': 'Minnesota HealthSolutions'}}}}