AI-Driven Consent Simplification Study

NCT ID: NCT07303517

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-08

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Informed Consent Comprehension Communication Disclosure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Informed Consent Readability Plain language Simplified consent forms Research ethics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1-Adult participants - Arm A

Will review the original ICF

Original ICF

Intervention Type BEHAVIORAL

Participant will review the original ICF

Group 1 - Adult participants - Arm B

Will review the simplified ICF

AI Simplified ICF

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Participant will review the original ICF

Podcast - Original ICF

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Participant will review the AI Simplified ICF

Podcast - Simplified ICF

Intervention Type BEHAVIORAL

Listen to a podcast that is developed to provide an engaging format for the simplified ICF.

Group 2 - Investigators

PIs who are health providers that perform clinical trials

Original ICF

Intervention Type BEHAVIORAL

Participant will review the original ICF

AI Simplified ICF

Intervention Type BEHAVIORAL

Participant will review the AI Simplified ICF

Podcast - Original ICF

Intervention Type BEHAVIORAL

Listen to a podcast that is developed to provide an engaging format for the original ICF.

Group 3 - IRB individuals

Individuals involved in IRB activities (chairs, committee members, staff)

Original ICF

Intervention Type BEHAVIORAL

Participant will review the original ICF

AI Simplified ICF

Intervention Type BEHAVIORAL

Participant will review the AI Simplified ICF

Podcast - Original ICF

Intervention Type BEHAVIORAL

Listen to a podcast that is developed to provide an engaging format for the original ICF.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Original ICF

Participant will review the original ICF

Intervention Type BEHAVIORAL

AI Simplified ICF

Participant will review the AI Simplified ICF

Intervention Type BEHAVIORAL

Podcast - Original ICF

Listen to a podcast that is developed to provide an engaging format for the original ICF.

Intervention Type BEHAVIORAL

Podcast - Simplified ICF

Listen to a podcast that is developed to provide an engaging format for the simplified ICF.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Group 1:

* 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 1: None
* 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)"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arash Naeim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Erinn Knox

Role: CONTACT

Phone: (310) 490-4888

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-24-6074

Identifier Type: -

Identifier Source: org_study_id