Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
230 participants
OBSERVATIONAL
2026-01-08
2026-12-01
Brief Summary
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Simplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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Group 1-Adult participants - Arm A
Will review the original ICF
Original ICF
Participant will review the original ICF
Group 1 - Adult participants - Arm B
Will review the simplified ICF
AI Simplified ICF
Participant will review the AI Simplified ICF
Group 1- Adult participants - Arm C
Will listen to a podcast in conjunction to the original ICF
Original ICF
Participant will review the original ICF
Podcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Group 1-Adult participants - Arm D
Will listen to a podcast in conjunction to the simplified ICF
AI Simplified ICF
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Podcast - Simplified ICF
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Group 2 - Investigators
PIs who are health providers that perform clinical trials
Original ICF
Participant will review the original ICF
AI Simplified ICF
Participant will review the AI Simplified ICF
Podcast - Original ICF
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Group 3 - IRB individuals
Individuals involved in IRB activities (chairs, committee members, staff)
Original ICF
Participant will review the original ICF
AI Simplified ICF
Participant will review the AI Simplified ICF
Podcast - Original ICF
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Interventions
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Original ICF
Participant will review the original ICF
AI Simplified ICF
Participant will review the AI Simplified ICF
Podcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Podcast - Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Eligibility Criteria
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Inclusion Criteria
* Age 60 years and above
* UCLA patient
* English speaking
* Ability to provide informed consent
Group 2:
* UCLA investigators who are health providers that perform clinical trials
* Must be clinical research investigatory and staff actively involved in research operations at UCLA
* English speaking
Group 3:
* Individuals involved in IRB activities (chairs, committee members, staff)
* Must be a director or staff at UCLA
* English speaking
Exclusion Criteria
* Group 2: PI and co-PIs of the study "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"
* Group 3: Individuals from the IRB who have reviewed the study submission for "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"
18 Years
ALL
Yes
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Arash Naeim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Central Contacts
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Other Identifiers
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IRB-24-6074
Identifier Type: -
Identifier Source: org_study_id