Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03419832
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The New Executive and Appendix Template (NEAT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jandrews@wakehealth.edu', 'phone': '336-716-7658', 'title': 'Joseph E. Andrews, Jr., PhD, CIP, CCRP', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from time of consent through end of study, up to 24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comprehension of the NEAT Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'OG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Following the consent process, participants will be administered the Comprehension tool to measure their comprehension. The summary scores will be used to address the primary aim of whether or not the NEAT consent form improves participant comprehension. There are 7 questions, each question is rated 0-2 with a total scale of 0-14. Higher values denotes better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'OG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'classes': [{'title': 'Much easier to read and understand', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat easier to read and understand', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'About the same', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Harder/Much harder to read and understandBottom of Form', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the readability and understandability of the consent form and selected responses from the following options: Much easier to read and understand, Somewhat easier to read and understand, About the same, or Harder/Much harder to read and understand. The frequency of each response was reported.', 'unitOfMeasure': 'number of each response', 'reportingStatus': 'POSTED', 'populationDescription': 'Two people did not complete this question in the Standard Form Arm'}, {'type': 'SECONDARY', 'title': 'Qualitative Analysis of the Format and Design of the Consent Form by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'OG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'classes': [{'title': 'Much better format and design', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat better format and design', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'About the same format and design', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat worse format and design', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.', 'unitOfMeasure': 'number of each response', 'reportingStatus': 'POSTED', 'populationDescription': 'Two people did not complete this question in the Standard Form Arm.'}, {'type': 'SECONDARY', 'title': 'Qualitative Analysis of the Time of Discussion of the Consent Form by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'OG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'classes': [{'title': 'Much shorter time', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat shorter time', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'About the same time', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat/Much longer time', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the time of discussion of the consent form and selected from following options: Much shorter time, Somewhat shorter time, About the same time, or Somewhat/Much longer time. The frequency of each response was reported.', 'unitOfMeasure': 'number of each response', 'reportingStatus': 'POSTED', 'populationDescription': 'Two people did not complete this question in the Standard Form Arm.'}, {'type': 'SECONDARY', 'title': 'Qualitative Analysis of the Format and Design of the Consent Form by Study Team', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'OG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'timeFrame': 'at visit one, up to 24 hours', 'description': 'The study team member qualitative data about their opinion of using the form will be collected. Study team members were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for this outcome. No data to report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'FG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).\n\nNEAT Form: The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.'}, {'id': 'BG001', 'title': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).\n\nStandard Form: The regular IRB approved version.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Aged 65 or older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Specific age was not collected. The study team only confirmed that participants were 65 or older.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender baseline characteristic data was not collected for this study.'}, {'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': 'Baseline Analysis Data was not collected except to confirm that subjects were 65 or older.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-03', 'size': 302267, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-20T08:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2018-01-22', 'resultsFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-20', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comprehension of the NEAT Form', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Following the consent process, participants will be administered the Comprehension tool to measure their comprehension. The summary scores will be used to address the primary aim of whether or not the NEAT consent form improves participant comprehension. There are 7 questions, each question is rated 0-2 with a total scale of 0-14. Higher values denotes better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the readability and understandability of the consent form and selected responses from the following options: Much easier to read and understand, Somewhat easier to read and understand, About the same, or Harder/Much harder to read and understand. The frequency of each response was reported.'}, {'measure': 'Qualitative Analysis of the Format and Design of the Consent Form by Participants', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.'}, {'measure': 'Qualitative Analysis of the Time of Discussion of the Consent Form by Participants', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'Subjects were asked about the time of discussion of the consent form and selected from following options: Much shorter time, Somewhat shorter time, About the same time, or Somewhat/Much longer time. The frequency of each response was reported.'}, {'measure': 'Qualitative Analysis of the Format and Design of the Consent Form by Study Team', 'timeFrame': 'at visit one, up to 24 hours', 'description': 'The study team member qualitative data about their opinion of using the form will be collected. Study team members were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARIC'], 'conditions': ['Comprehension', 'Informed Consent']}, 'descriptionModule': {'briefSummary': 'There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their ability to make informed decisions about participation. The need for revisions to the informed consent document design is supported by empirical research.This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) form when used in the consent process for individuals participating in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study.', 'detailedDescription': 'The importance of informed consent is to ensure that participants in clinical research are provided the opportunity to make autonomous choices is a paramount ethical premise in human research. The effectiveness of consent document design and consent process to accurately and fully convey the elements of informed consent is critical and deserves further study. Development of an improved informed consent document design for clinical studies would be a valuable contribution to human research. Chunking sentences or phrases in text into related groupings resulted in a positive significant improvement in reading comprehension among students with poor reading skills. Because the information contained in consent documents can be complex, detailed, and novel for potential research participants, the use of a modified form of chunking may be an effective and a low cost way of improving comprehension of the elements of consent. Specifically, the primary objective of the study is to determine if participants who receive the NEAT form report greater comprehension at the end of the consent process, than participants who receive a standard form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are eligible for the ARIC study, with which this pilot study is cooperating.\n\nExclusion Criteria:\n\n* Any individuals not eligible for the ARIC study.'}, 'identificationModule': {'nctId': 'NCT03419832', 'briefTitle': 'The New Executive and Appendix Template (NEAT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The NEAT Study: An Examination of a Novel Consent Form Design in a Real-world Setting', 'orgStudyIdInfo': {'id': 'IRB00031904'}, 'secondaryIdInfos': [{'id': '5UL1TR001420-03', 'link': 'https://reporter.nih.gov/quickSearch/5UL1TR001420-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEAT Form', 'description': 'Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).', 'interventionNames': ['Other: NEAT Form']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Form', 'description': 'Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).', 'interventionNames': ['Other: Standard Form']}], 'interventions': [{'name': 'NEAT Form', 'type': 'OTHER', 'description': 'The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.', 'armGroupLabels': ['NEAT Form']}, {'name': 'Standard Form', 'type': 'OTHER', 'description': 'The regular IRB approved version.', 'armGroupLabels': ['Standard Form']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Joseph Andrews, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}