Stress and CKD Among African Americans

Emory University

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Behavioral: Racialized Stressful Event Recall; Behavioral: Non-Racialized Stressful Event Recall

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03387319

IRB00099892

1R21DK112108 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient at Emory University Hospital Midtown
• Self-identify as African American or Black
• Estimated glomerular filtration rate (eGFR) ≥ 15, or <90

Exclusion criteria

• Mental disorder that prevents the completion of the Computer Assisted Personal Interview (CAPI) and the stressful recall manipulation
• Currently on maintenance dialysis
• Unable or unwilling to undergo intravenous catheterization

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Racialized Stressful Event Recall

Experimental group

Description:

Participants in this study are recall a stressful event related to race.

Treatment:

Behavioral: Racialized Stressful Event Recall

Non-racialized Stressful Event Recall

Experimental group

Description:

Participants in this study arm recall a stressful event unrelated to race.

Treatment:

Behavioral: Non-Racialized Stressful Event Recall