Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04841967
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility Trial of the TELL Tool Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phersh@uic.edu', 'phone': '3129961305', 'title': 'Patricia Hershberger', 'organization': 'University of Illinois Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Parents who participated in the pilot, RCT were assessed about adverse events at the 4-week and 12-week post-test data collection time points. The overall implementation of the pilot, RCT was from recruitment of our first parent participant into the pilot, RCT on July 26, 2021 through the 12-week post-test time point, which was September 30, 2022 when data collection for the pilot, RCT was completed.', 'description': "At the conclusion of the 4-week and 12-week data collection time points, participants were asked via an open-ended survey question about their reaction to participating in the study to assess for adverse events. For parents that reported disclosure to their children at the 4-week or 12-week time points, parent participants were asked about their child(ren)'s reaction(s) to the disclosure.", 'eventGroups': [{'id': 'EG000', 'title': 'TELL Tool Group', 'description': 'Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.\n\nTELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'eBook Attention-Control', 'description': 'Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.\n\neBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Disclosed the Donor Conception to Their Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TELL Tool Group', 'description': 'Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.\n\nTELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.'}, {'id': 'OG001', 'title': 'eBook Attention-Control', 'description': 'Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.\n\neBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.', 'description': "Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Disclosure Intention', 'timeFrame': 'Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Disclosure Competence', 'timeFrame': 'Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Disclosure Anxiety', 'timeFrame': 'Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Computer Adapted Test (CAT). Total scores for CAT will be comparable across participants.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability of the TELL Tool and eBook', 'timeFrame': 'Immediate posttest', 'description': "Participant's reports to the Acceptability Survey. No score range (19 items)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability of the TELL Tool, eBook and Study Protocol', 'timeFrame': 'Month 15', 'description': "Participant's responses to the Cognitive Interviews. No score range (Cognitive Interview Guide for Acceptability)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pretesting of the Measures', 'timeFrame': 'Before baseline', 'description': "Participant's (8 to 12 participants who are not part of the pilot randomized controlled trial) responses to Cognitive Interviews. No score range. (Cognitive Interview Guide for Measures)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TELL Tool Group', 'description': 'Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.\n\nTELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.'}, {'id': 'FG001', 'title': 'eBook Attention-Control', 'description': 'Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.\n\neBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Recruitment Goal Achieved', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TELL Tool Group', 'description': 'Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.\n\nTELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.'}, {'id': 'BG001', 'title': 'eBook Attention-Control', 'description': 'Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.\n\neBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.'}, {'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': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', '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': '39', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-06', 'size': 122560, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-18T12:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Parents will be randomized into two groups (either the TELL Tool group or the attention control eBook group) using a permuted block approach that is stratified by the age categories of the parent's children and using an online (REDCap) randomization module."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parent participants will be randomized to one of two groups: (1) TELL Tool group, or (2) eBook attention control group. Data will be collected at baseline, immediate posttest (post-TELL tool/post-eBook attention control) and at 2 additional time points (months 1 and 3)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2021-04-08', 'resultsFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-10', 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability of the TELL Tool and eBook', 'timeFrame': 'Immediate posttest', 'description': "Participant's reports to the Acceptability Survey. No score range (19 items)"}, {'measure': 'Acceptability of the TELL Tool, eBook and Study Protocol', 'timeFrame': 'Month 15', 'description': "Participant's responses to the Cognitive Interviews. No score range (Cognitive Interview Guide for Acceptability)"}, {'measure': 'Pretesting of the Measures', 'timeFrame': 'Before baseline', 'description': "Participant's (8 to 12 participants who are not part of the pilot randomized controlled trial) responses to Cognitive Interviews. No score range. (Cognitive Interview Guide for Measures)"}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Disclosed the Donor Conception to Their Children', 'timeFrame': 'Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.', 'description': "Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)"}], 'secondaryOutcomes': [{'measure': 'Change in Disclosure Intention', 'timeFrame': 'Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)"}, {'measure': 'Change in Disclosure Competence', 'timeFrame': 'Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)"}, {'measure': 'Change in Disclosure Anxiety', 'timeFrame': 'Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3', 'description': "Parent's report on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Computer Adapted Test (CAT). Total scores for CAT will be comparable across participants."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Issues', 'Disclosure', 'Parenting']}, 'descriptionModule': {'briefSummary': "A radical paradigm shift is taking place where technology, notably the explosion in easy accessible direct-to-consumer genetic testing (e.g., 23andMe) and a high consumer interest in genealogy (e.g., Ancestry.com), has hijacked gamete (eggs, sperm) and embryo donation recipient parents' control over whether to inform their children about their donor conception. Historically, the practice of gamete donation has been shrouded in secrecy, however, the skyrocketing use of direct-to-consumer genetic testing means that at any point in an adult life, an uninformed donor-conceived person can learn their DNA does not match their presumed ancestry of their parents and family members, putting into question their genetic relatedness to their parents and launching a spiraling sequence of negative health consequences and trauma. Furthermore, the lack of one's knowledge about actual genetic heritage in the age of precision medicine can be enormously detrimental to health and can result in medical maltreatment, including death. To address this serious problem and in accordance with International Patient Decision Aid Standards, we developed a digital, tailored, multicomponent Tool to Empower ParentaL TeLling and Talking (i.e., TELL Tool). The objective of this R34 study is to examine the feasibility, acceptability, and preliminary effects of the TELL Tool intervention in a pilot randomized-controlled feasibility trial with 60 donor-recipient parents and 10 clinicians to determine intervention viability and inform a larger, efficacy trial. An eBook with content about good parenting principles serves as the attention control.", 'detailedDescription': 'The feasibility trail will use a longitudinal, mixed-methods design that is guided by International Patient Decision Aid Standards and NIH Guidelines for pilot studies. The study design is necessary to achieve the objective of the study, which is to examine the feasibility and acceptability of the TELL Tool intervention in a pilot randomized-controlled feasibility trial to determine intervention viability and inform a larger, efficacy trial. There are three Specific Aims that are: Aim 1 determine feasibility of the study procedures (e.g., recruitment, retention) by pilot testing the TELL Tool using a 2-arm randomized-controlled trial (RCT) with 60 donor-recipient parents using pre- to post-test measures for disclosure intention, competence, and anxiety. (A pretesting of the measures will be implemented with 8 to 12 donor-recipient parents, who are not participants of the pilot RCT, prior to launching the RCT.); Aim 2 survey participating donor-recipient parents at 2 additional time points (4 and 12 weeks/months 1 and 3) post-intervention/attention control completion to obtain meaningful outcome data about actual parental disclosure to their donor-conceived children; and Aim 3 refine the study tools (e.g., TELL Tool, eBook) through post-intervention/attention control written evaluations with participating donor-recipient parents and cognitive interviews with 10 donor-recipient parents, who are a sub-sample of parents from our larger sample of parents, and 10 clinicians. The findings will inform the final protocol for a larger, efficacy trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Parents:\n\n* Reside in the United States or one of its recognized territories\n* Conceived 1 or more children via gamete (egg/sperm) or embryo donation who are currently between the ages of 1 - 16 years of age\n* Have not informed their child(ren) about their donor conception origins\n* Are 21 years-of-age or older\n* English speaking\n\nInclusion Criteria Clinicians:\n\n* Active practice as a healthcare professional (e.g., nurse, physician, psychologist, social worker)\n* Provide education and/or counseling to gamete (eggs, sperm) and/or embryo donation recipient parents about disclosure to their children in the United States or one of its recognized territories\n* Able to provide feedback and insight about new tools to assist gamete (eggs, sperm) and/or embryo donation recipient parents with disclosure to their donor-conceived children\n* Are 21 years-of-age or older\n* English speaking\n\nExclusion Criteria Parents:\n\n* Have already disclosed the donor conception to their donor-conceived child or children\n* Reside outside of the United States or one of its recognized territories\n\nExclusion Criteria Clinicians:\n\n* Not directly involved in providing education and/or counseling to gamete (eggs, sperm) and/or embryo donation recipient parents about disclosure to their children\n* Are a member of the research team'}, 'identificationModule': {'nctId': 'NCT04841967', 'briefTitle': 'Feasibility Trial of the TELL Tool Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents', 'orgStudyIdInfo': {'id': '2020-1086'}, 'secondaryIdInfos': [{'id': 'R34NR019278', 'link': 'https://reporter.nih.gov/quickSearch/R34NR019278', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TELL Tool Group', 'description': 'Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.', 'interventionNames': ['Behavioral: TELL Tool Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'eBook Attention-Control', 'description': 'Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.', 'interventionNames': ['Behavioral: eBook Attention Control']}], 'interventions': [{'name': 'TELL Tool Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['TELL Tool'], 'description': 'A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.', 'armGroupLabels': ['TELL Tool Group']}, {'name': 'eBook Attention Control', 'type': 'BEHAVIORAL', 'otherNames': ['eBook'], 'description': 'A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.', 'armGroupLabels': ['eBook Attention-Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Patricia Hershberger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'When we publish our results, electronic copies of publications will be deposited in PubMed Central within four weeks of acceptance by a journal. We will also submit our results to ClinicalTrials.gov Protocol Registration and Results System as required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Patricia Hershberger, PhD, RN, FNP-BC, FAAN', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}