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NCT03975439 Clinical Trial

Chronic Kidney Disease and Cardiovascular Disease Risk Assessment

Hypertension Clinical Trial

Official title:
Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03975439
Other study ID # 2019-004
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date February 5, 2020

Study information
Verified date July 2022
Source Pacific Northwest University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will investigate chronic kidney disease (CKD) and cardiovascular disease (CVD) risk factors in a sample population of Hispanics/Latinos and Caucasians in Yakima county that are rural dwelling. This investigation is intended to provide information on the impact rural geographical location and social determinants of health (SDOH) have on CKD and CVD risk factors.

Description:

Yakima County has a large hispanic farmworker population. The peak work times are between May and September. There is a growing body of research that shows the risk of agricultural workers in work environments with extreme heat. The purpose of this pilot study is to look at incidence of non-diagnosed chronic kidney disease within Yakima County to inform future studies to examine other factors and unique bio-markers that may help in the early diagnosis of heat related injuries in agricultural workers.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 5, 2020
Est. primary completion date February 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Between the ages of 18 and 75 Exclusion Criteria: - Active malignancy - Currently pregnant - End stage renal disease requiring dialysis - Current active treatment for diabetes mellitus - Current care by a nephrologist for chronic kidney disease

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hemoglobin A1C
Finger stick hemoglobin A1C
• Urinalysis
Urinalysis by dip stick looking for urine protein level
• Whole blood creatinine level
Finger stick looking for serum creatinine as an estimate of renal function

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pacific Northwest University of Health Sciences

References & Publications (7)

Coronado GD, Thompson B, Tejeda S, Godina R, Chen L. Sociodemographic factors and self-management practices related to type 2 diabetes among Hispanics and non-Hispanic whites in a rural setting. J Rural Health. 2007 Winter;23(1):49-54. — View Citation

Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006. — View Citation

Hébert JR, Braun KL, Kaholokula JK, Armstead CA, Burch JB, Thompson B. Considering the Role of Stress in Populations of High-Risk, Underserved Community Networks Program Centers. Prog Community Health Partnersh. 2015;9 Suppl:71-82. doi: 10.1353/cpr.2015.0028. — View Citation

Krishna S, Gillespie KN, McBride TM. Diabetes burden and access to preventive care in the rural United States. J Rural Health. 2010 Winter;26(1):3-11. doi: 10.1111/j.1748-0361.2009.00259.x. — View Citation

Kurpas D, Mroczek B, Bielska D. Rural and urban disparities in quality of life and health-related behaviors among chronically ill patients. Rural Remote Health. 2014;14(2):2485. Epub 2014 Jun 10. — View Citation

Melvin CL, Corbie-Smith G, Kumanyika SK, Pratt CA, Nelson C, Walker ER, Ammerman A, Ayala GX, Best LG, Cherrington AL, Economos CD, Green LW, Harman J, Hooker SP, Murray DM, Perri MG, Ricketts TC; Workshop Working Group on CVD Prevention in High-Risk Rural Communities. Developing a research agenda for cardiovascular disease prevention in high-risk rural communities. Am J Public Health. 2013 Jun;103(6):1011-21. doi: 10.2105/AJPH.2012.300984. Epub 2013 Apr 18. — View Citation

Shoham DA, Vupputuri S, Kaufman JS, Kshirsagar AV, Diez Roux AV, Coresh J, Heiss G. Kidney disease and the cumulative burden of life course socioeconomic conditions: the Atherosclerosis Risk in Communities (ARIC) study. Soc Sci Med. 2008 Oct;67(8):1311-20. doi: 10.1016/j.socscimed.2008.06.007. Epub 2008 Jul 28. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA Finger stick and urinalysis will be done at the time of screening At the time of screening
Secondary Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA Finger stick will be done at the time of screening At the time of screening
Secondary Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA Measurement of blood pressure At the time of screening
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