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APOL1 Genetic Testing for Kidney Disease
N/A
Recruiting
Led By Elisa J Gordon
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cognitively intact individuals
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately day 60
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well a chatbot-based program works in informing African American adults about their risk for kidney disease if they donate a kidney.
Who is the study for?
This trial is for cognitively intact, English-speaking adults of African descent, including a wide range of nationalities like African American/Black, Jamaican, and others who are considering becoming living kidney donors. It's not for those without African ancestry or pregnant women.
What is being tested?
The study tests a culturally adapted APOL1 genetic testing program with components like genetic counseling and EHR integration. It uses the 'Gia' chatbot to help potential donors understand their risks and make informed decisions about donation.
What are the potential side effects?
Since this trial involves genetic testing and counseling rather than medication or invasive procedures, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts from learning about their genetic risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally sharp and can make decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately day 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decisional Conflict Scale (DCS)
Secondary study objectives
Preparation for Decision Making Scale (PDMS) Scores range from: Higher scores reflect greater preparation for decision making (a better outcome)
Satisfaction with the Informed Consent Process
Willingness to Donate Scores range from: 0 to 10. Higher scores reflect greater willingness to donate.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment3 Interventions
APOL1 testing program
Group II: Control ArmActive Control1 Intervention
No intervention will be administered. Usual care will be administered.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,125 Total Patients Enrolled
Georgetown UniversityOTHER
350 Previous Clinical Trials
138,775 Total Patients Enrolled
Elisa J GordonPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally sharp and can make decisions.I am 18 years old or older.My gender does not affect my eligibility.People who want to donate a kidney, whether to a specific person or to anyone in need.People with specific ethnic backgrounds and African ancestry are not eligible to be living kidney donors.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.