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OpenTrials
Completed

NCT Number: NCT07747363

Community-Based Screening for Chronic Kidney Disease

Chronic Kidney Disease (CKD) incubates for years before kidney function declines to such low levels that patients develop symptoms and present for medical evaluation. The earlier in its course that CKD is identified, the more likely that medical care can slow or stop further worsening toward complete loss of kidney function, or end-stage kidney disease (ESKD). Individuals living in low income, largely minority communities are at greater risk for CKD than those in wealthier, non-minority communities but have historic mistrust of research. This project will conduct screening for high levels of a urine protein called albumin, indicating underlying CKD, in churches known to have the trust of communities, to identify asymptomatic individuals with CKD to be offered referral for kidney-protective medical care. Upon completion, this project will determine if individuals so identified with CKD will 1) accept referral for CKD care; 2) remain in care for at least 12 months; and 3) achieve a reduction in urine albumin levels, indicating CKD improvement. As such, this project will determine the value of community-based screening to reduce CKD prevalence.

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Key information

About this study

The long-term objective of this study is to determine if community-based screening for chronic kidney disease (CKD) can 1) identify individuals with CKD in their lived environments; 2) lead to those identified with CKD accepting referral for kidney-protective medical care; and 3) sustain medical care long enough to achieve documented improvement of their CKD. Chronic kidney disease is increasing in incidence and prevalence, leading to increasing mortality from diseases for which CKD increases risk like cardiovascular disease (CVD), reduced quality of life associated with end-stage kidney disease (ESKD), and increasing economic costs of managing progressive CKD, particularly the ESKD costs of dialysis and kidney transplant. Unfortunately, CKD initiation and progression is asymptomatic until kidney function declines to very low levels at which patients present with symptoms to health systems for medical evaluation. Diagnosis of CKD is commonly made at its late stages when kidney-protective medical therapy is less effective. Kidney protective medical therapy is much more effective when instituted in early CKD stages so its early identification is critical. Because patients with CKD progress many years toward ESKD asymptomatically, it is best to identify them in their lived environments when they are in earlier stages at which kidney-protective medical care is most effective. Individuals living in low-income, largely minority communities, are at higher risk for CKD than those living in wealthier, non-minority communities. Because of historic mistreatment of these communities by the U.S. research and health system enterprises, many individuals in these communities harbor justified mistrust of the U.S. medical research and health system enterprise. Because of this mistrust, many individuals are less willing to participate in research studies and are less willing to accept referral for medical care even if they have been diagnosed with a condition that can be improved with medical care. The specific aims of this study are to determine if individuals from low-income, largely minority communities will 1) accept CKD screening done by dipstick measurement of urine albumin (mg)-to-creatinine (g) ratio (UACR); 2) accept outpatient clinic referral for kidney-protective medical care for those found to have CKD by high UACR (>30 mg/g); and 3) sustain clinic care for at least twelve months and achieve improved CKD as assessed by reduced UACR from baseline. Studies support that individuals from low-income, largely minority communities are more likely to accept and follow through on guidance received from community-based institutions with which they are familiar that have "trusted agency". Such institutions include churches in these communities that have earned the trust of the communities over many years. These churches often have medical ministries through which they conduct "health fairs" during which church members and non-church members from the surrounding communities come to learn health topics, learn about diseases common to their communities, and are offered the opportunity to be screened for some of these diseases. Studies also support that community members are more likely to accept and follow through on guidance from individuals from and/or with knowledge of their communities, even if these individuals are not traditional health professionals like physicians or nurses. We will employ trained community health workers (CHW) to be part of the research team, are from or familiar with these communities and so have the trust of the community, and who will conduct the screening under the supervision of the principal investigator. At a screened area of the church during a health fair a CHW will explain the study to attendees and if the attendee signs informed consent, the CHW will measure blood pressure and ask the attendee to provide at least 20 ml urine for UACR. If UACR is > 30 mg/g, it will be sent for laboratory confirmation. If confirmed, the attendee will be offered study enrollment and offered outpatient clinic referral to receive kidney-protective kidney care at no out of pocket cost. Those who agree to be enrolled will be included in the study whether they accept referral (experimental group) or decline (control group). All will be asked to return to the church in 12 months for repeat blood pressure and UACR measurement. Those with blood pressure >140/90 but UACR <30 mg/g will be offered outpatient clinic referral but will not be enrolled in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily attending community-based (typically a church) health fair;
  • 18-70 yrs old
  • Without symptoms
  • Has never been told to have chronic kidney disease (CKD) or other kidney-related conditions
  • non-smoking (smoking is associated with increased urine albumin excretion)
  • Able to provide informed consent.

Exclusion criteria

  • Symptoms of chronic disease (e.g., shortness of breath, chest pain, fatigue poor appetite
  • Known kidney disease
  • current smoker
  • unable to provide informed consent.

Treatment and study plan

outpatient clinic kidney-protective care

Other

Participants in the Placebo Comparative group are those who decline outpatient referral for outpatient clinic kidney-protective medical care and so receive no medical care

Primary outcomes

  1. Albuminuria change

    Time frame: 12 months

    Change in 12-month urine albumin (mg)-to-creatinine (g) ratio (UACR) compared with the baseline UACR measured at the same community-based setting at which screening for chronic kidney disease was done.

  2. Systolic blood pressure change

    Time frame: 12 months

    Change in 12-month systolic blood pressure compared with the baseline systolic blood pressure measured with an automated cuff with both measurements done at the same community-based setting at which screening for chronic kidney disease was done.

Secondary outcomes

  1. Diastolic blood pressure change

    Time frame: 12 months

    Change in 12-month diastolic blood pressure compared with the baseline diastolic blood pressure measured with an automated cuff with both measurements done at the same community-based setting at which screening for chronic kidney disease was done.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2024
First posted
Aug 5, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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