Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 8:44 AM
Study NCT ID:
NCT06735469
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2024-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Preference Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant preference for clinical trial attributes', 'timeFrame': 'Baseline', 'description': 'Utility values generated from multinomal logit estimates from a discrete choice experiment of 8 hypothetical choices (Trial A, B, or neither).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Trials']}, 'descriptionModule': {'briefSummary': "Population subgroups experiencing health disparities are often also underrepresented in clinical trials. These groups include individuals from minoritized racial and ethnic groups, people from lower socioeconomic backgrounds, and men or women, depending on the study area. Identifying approaches to reduce health disparities will remain stalled until clinical trials can recruit and retain diverse clinical trial participants. To improve recruitment across studies, there is a need to understand how diverse populations view specific clinical trial attributes that could be manipulated to increase interest in trials. To address this need, this project will use a discrete choice experiment to identify and prioritize specific trial attributes under investigators' control that could be leveraged to enhance clinical trial participation rates in underrepresented groups. This project will evaluate participants' preferences of 1) return of full versus limited results to participants, 2) balancing a study's participant burden with its ability to address multiple research aims, 3) incentivizing clinical assessments vs. conducting homebased assessments, and 4) results generalizable to specific social groups versus the broader population. This experiment will be conducted with a sample of potential clinical trial participants (N = 800) that is diverse in terms of self-reported gender, racial and ethnic identity, education, and chronic disease status. The results of this study will be used to design a randomized comparison of enhanced clinical trial attributes across multiple health conditions to evaluate whether using the enhanced trial features can more efficiently recruit underrepresented participants into clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'United States adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internet access with audio and visual capabilities\n* Reside within the United States\n* Read and speak English\n\nExclusion Criteria:\n\n* Under 18 years of age\n* No internet access\n* Reside outside of the United States\n* Do not read and speak English'}, 'identificationModule': {'nctId': 'NCT06735469', 'briefTitle': 'Clinical Trial Preference Study', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Leveraging Discrete Choice Experiments to Increase Participant Diversity in Future Clinical Trials', 'orgStudyIdInfo': {'id': 'ORA# 24021303'}, 'secondaryIdInfos': [{'id': 'R03DK139135', 'link': 'https://reporter.nih.gov/quickSearch/R03DK139135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Discrete choice experiment', 'type': 'OTHER', 'description': "Participants will state their preferences for 1) return of full versus limited results to participants (trust/personal benefit), 2) balancing a study's participant burden with the study's ability to address multiple research aims (burden/knowledge generation), 3) incentivizing clinical assessments vs. conducting home-based assessments (personal benefit/burden), and 4) results generalizable to specific social groups versus the broader population. Participants will evaluate these attributes within a hypothetical trial to prevent chronic diseases."}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available in the Open Science Framework. Data will be made available as soon as possible after the data collection period has ended and will occur after the study investigators have had reasonable time to prepare manuscripts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melissa M. Crane, PhD', 'investigatorAffiliation': 'Rush University Medical Center'}}}}