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出境医 / 临床实验 / Chronic Kidney Disease and Cardiovascular Disease Risk Assessment

Chronic Kidney Disease and Cardiovascular Disease Risk Assessment

Study Description
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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Diabetes Mellitus Hypertension Diagnostic Test: Hemoglobin A1C Diagnostic Test: Urinalysis Diagnostic Test: Whole blood creatinine level

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
    Finger stick and urinalysis will be done at the time of screening


Secondary Outcome Measures :
  1. Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
    Finger stick will be done at the time of screening

  2. Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA [ Time Frame: At the time of screening ]
    Measurement of blood pressure


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019) 		Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
Finger stick and urinalysis will be done at the time of screening
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 4, 2019)
  • Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
    Finger stick will be done at the time of screening
  • Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA [ Time Frame: At the time of screening ]
    Measurement of blood pressure
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Kidney Disease and Cardiovascular Disease Risk Assessment
Official Title Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chronic Kidney Diseases
  • Diabetes Mellitus
  • Hypertension
Intervention
  • Diagnostic Test: Hemoglobin A1C
    Finger stick hemoglobin A1C
  • Diagnostic Test: Urinalysis
    Urinalysis by dip stick looking for urine protein level
  • Diagnostic Test: Whole blood creatinine level
    Finger stick looking for serum creatinine as an estimate of renal function
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 4, 2019) 		500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975439
Other Study ID Numbers 2019-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mark D. Baldwin, Pacific Northwest University of Health Sciences
Study Sponsor Pacific Northwest University of Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Mark D Baldwin, DO Pacific Northwest University of Health Science
PRS Account Pacific Northwest University of Health Sciences
Verification Date June 2019

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