Clinical trial NCT03975439: Chronic Kidney Disease and Cardiovascular Disease Risk Assessment
Official title: Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Diseases
Diabetes Mellitus
Hypertension
Lead sponsor: Pacific Northwest University of Health Sciences
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults of between the ages of 18 and 75 who do not meet the exclusion criteria and wish to undergo screening for kidney disease and diabetes.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA
timeFrame: At the time of screening
Secondary outcomes:
measure: Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA
timeFrame: At the time of screening
measure: Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA
timeFrame: At the time of screening
Other outcomes:
Locations:
Study officials:
affiliation: Pacific Northwest University of Health Science
name: Mark D Baldwin, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hebert 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(0):71-82. doi: 10.1353/cpr.2015.0028.
citation: 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. doi: 10.1111/j.1748-0361.2006.00067.x.
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.
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.
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.
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.
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.