Chronic Kidney Disease Clinical Trial
Official title:
Social Stress, Inflammation, and Chronic Kidney Disease Among African Americans
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.
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.
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