Home-base Kidney Care in Zuni Indians
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

Intervention name(s): Educational and lifestyle coaching
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Native American; Community Health Representative; Home base; Diabetes; Point of care testing; Patient Activation Measure; Patient preferences