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Clinical Trial Summary

The goal of this study is to determine whether experiencing stress from discrimination may increase chronic kidney disease (CKD) progression in African Americans. Study participation occurs over the course of 2 days, and participant time burden is expected to be about 4.5 hours, plus a 24-hour period of wearing a blood pressure monitor.


Clinical Trial Description

On Day 1, the project coordinator will explain the study to participants and answer any questions he/she may have. Those who agree to participate in the study will provide consent at the clinic and will also be asked to complete a questionnaire on an iPad in a small, private room at the clinic. The participant will complete the questionnaire alone, however, the project coordinator will read questions aloud if the participant chooses. Before leaving on Day 1, participants will fitted with a blood pressure monitor to be worn for the next 24 hours.

The clinical intervention portion of the study occurs during the morning of Day 2 (between 9:00 AM and 11:00 AM). Participants will be instructed to bring the blood pressure monitor and a list of current medications (or the actual medications) with them. First, participants will provide a urine sample and undergo blood pressure testing. A research nurse will insert a catheter (a small thin tube) into the participant's vein, and allow a 30-minute resting period so that the participant gets used to the catheter, and then take a baseline blood draw. Participants will judge how distressed they feel in that moment using a standard scale and tell the project coordinator his/her rating. Next, participants will be randomized to one of two study arms such that half will recall the racial experience and half will recall the non-racialized stressful event. An audience of two observers of same race will wear white coats and watch as the participants recall the stressful events. The research nurse will draw blood and take blood pressure measurements at multiple time points during both recall experiences. Immediately before and after each recall task, the participant will again judge how distressed he/she is feeling in that moment using the same scale as before. The project coordinator will explain the purpose of the story recall and common ways that individuals may respond to the task (such as feeling anxious after the task). A total of 100 people will take part in this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03387319
Study type Interventional
Source Emory University
Contact
Status Completed
Phase N/A
Start date April 27, 2018
Completion date April 30, 2019

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