Stress and CKD Among African Americans
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Racialized Stressful Event Recall; Non-Racialized Stressful Event Recall
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, race-related event.
After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.; Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, event unrelated to race.
After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Of the 100 participants recruited, 80 will have a diagnosis of chronic kidney disease (CKD) and 20 will not. Participants will be randomized such that half will recall the racial experience and half will recall the non-racialized stressful event. Each participant will have an equal chance of being placed in the racialized or non-racialized experience group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Social stress; Inflammation