NCT03975439

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

4 days

First QC Date

June 4, 2019

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA

    At the time of screening

  • Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA

    At the time of screening

Interventions

Hemoglobin A1CDIAGNOSTIC_TEST

Finger stick hemoglobin A1C

UrinalysisDIAGNOSTIC_TEST

Urinalysis by dip stick looking for urine protein level

Finger stick looking for serum creatinine as an estimate of renal function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Between the ages of 18 and 75

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 26213406BACKGROUND
  • 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.

    PMID: 17300478BACKGROUND
  • 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.

    PMID: 21414565BACKGROUND
  • 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.

    PMID: 24916658BACKGROUND
  • 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.

    PMID: 20105262BACKGROUND
  • 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.

    PMID: 23597371BACKGROUND
  • 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.

    PMID: 18667261BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusHypertension

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Study Officials

  • Mark D Baldwin, DO

    Pacific Northwest University of Health Science

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 5, 2019

Study Start

February 1, 2020

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

July 14, 2022

Record last verified: 2022-07