NCT02915029

Home-base Kidney Care in Zuni Indians

Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
OTHER	Educational and lifestyle coaching	Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters. Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-09-26
• Last updated: 2019-12-04
• Results posted: 2019-12-04