Chronic Kidney Disease Clinical Trial
Official title:
Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians
People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD). CKD is associated with increased risks for heart disease and death. The burden of chronic kidney disease is increased among minority populations compare to Caucasians. The Zuni Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to assess the safety and efficacy of conducting a full-scale study to determine if home based care delivered by a collaborative team composed of community health workers and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.
Hypothesis: (1) The Zuni Health Initiative (ZHI) can integrate an innovative approach to Home
based kidney care (HBKC) utilizing tribal Community Health Representatives (CHRs), Point of
Care (POC) technology, telemedicine and motivational messaging in conjunction with patient
preferences and Patient Activation Measures (PAM) into the chronic care model to improve the
detection and treatment of Chronic Kidney Disease (CKD) and related risk factors; (2) This
model is generalizable to other high-risk communities e.g., Hispanic and American Indians in
Guadalupe, AZ being studied by NIDDK, NIH-Phoenix.
Specific Aim 1: Re-phenotype prior participants, to identify incident cases of CKD, estimate
progression rates, and identify participants for the proposed study of HBKC;
Specific Aim 2: Conduct a pilot study of HBKC in 120 people. Randomize households in a 1:1
allocation to usual care versus HBKC. Compare the changes in Patient Activation measure
(PAM), Adherence, BP, weight, HbA1c, UACR, eGFR and lipid profiles between the two groups
over the 1-year intervention period;
Specific Aim 3: Inform the design of the full-scale study by estimating anticipated
recruitment, adherence and dropout rates, sample size and reassessing the approach;
Specific Aim 4: Assess the exportability of the HBKC model to Hispanics and American Indians
in Guadalupe, AZ.
Study Outcomes: (1) The PAM and adherence; (2) Changes in clinical phenotypes including Cr,
UACR, A1c, body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids, and
inflammatory markers; (3) Changes in the quantitative traits such as diet and scores from a
battery of mental-health, self-efficacy, and quality of life instruments.
Health Impact: The active participation of the Zuni tribal leadership and IHS in this
protocol, and the general affordability of Zuni native CHR personnel, render the outcomes
that will be demonstrated by this proposal easily sustainable over the long term. If
successful, this program has the potential to change best-practices for CKD progression and
to reduce health disparities in a cost-effective and sustainable manner.
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