Clinical trial NCT03387319: Stress and CKD Among African Americans
Official title: Social Stress, Inflammation, and Chronic Kidney Disease Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Social stress
Inflammation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Subjective Units of Distress Scale (SUDS) Score
timeFrame: Baseline (Minute 0), Minute 5
measure: Change in Cooper's Racism Recall Scale Score
timeFrame: Baseline (Minute 0), Minute 5
measure: Change in Monocyte Chemoattractant Protein-1 (MCP-1) Level
timeFrame: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)
measure: Change in Interleukin-6 (IL-6) Level
timeFrame: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)
measure: Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR) Level
timeFrame: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)
measure: Change in Systolic Blood Pressure
timeFrame: Prior to IV insertion at Minute -30 through Minute 130
measure: Change in Diastolic Blood Pressure
timeFrame: Prior to IV insertion at Minute -30 through Minute 130
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Kimberly Arriola, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arriola KJ, Lewis TT, Pearce B, Cobb J, Weldon B, Valentin MIZ, Lea J, Vaccarino V. A randomized trial of race-related stress among African Americans with chronic kidney disease. Psychoneuroendocrinology. 2021 Sep;131:105339. doi: 10.1016/j.psyneuen.2021.105339. Epub 2021 Jun 18.