Home-base Kidney Care in Zuni Indians

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Educational and lifestyle coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of diabetes Clinical diagnosis of microalbuminuria Must be living in a household with more than 1 living participant Age 21 to 80 years Must have negative pregnancy test in women of child-bearing potential Exclusion Criteria: Life expectancy < 1 year On dialysis With renal transplant Pregnancy or absence of reliable birth control in women of child-bearing potential Malignancy except non-melanoma skin cancer Blind Unwilling or unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education and Lifestyle Coaching<br>Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence | Other: Educational and lifestyle coaching<br>* 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.<br>|
| No Intervention: Usual care (UC) control arm<br>once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure (PAM) -13 Item Questionnaire | Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | 12 months follow-up minus baseline values | 
| Patient Activation Measure (PAM) Level Greater Than 2 | Participants in an Activated category. Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. Level 1 labeled as patient being dis-engaged, Level 2 labeled as patient becoming aware of health condition but still struggling, level 3 labeled as patient is taking action and gaining control of their health care and level 4 labeled as maintaining behaviors and pushing forward - for our analysis purposes we classified participants into levels 3 and 4 (activated) and level 1 and 2 as not activated. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c | Changes in clinical values | 12 months minus baseline values | 
| Diastolic Blood Pressure | Changes in diastolic blood pressure on study. | 12 months minus baseline values | 
| Systolic Blood Pressure | Changes in Systolic blood pressure over study. | 12 months minus baseline values | 
| Body Mass Index | Changes in the value of body mass index (BMI) | 12 months minus baseline values | 
| Low-density Lipoprotein LDL Cholesterol | Changes in serum LDL cholesterol on study | 12 months minus baseline values | 
| High-density Lipoprotein HDL Cholesterol | Change in serum HDL cholesterol on study | 12 months minus baseline values | 
| Triglycerides | Change in serum triglycerides on study | 12 months minus baseline values | 
| Serum Total Cholesterol | Change in total cholesterol on study | 12 months minus baseline values | 
| High Sensitive C-reactive Protein-hsCRP | Changes in the serum c-reactive protein on study | 12 months minus baseline values | 
| Serum Total Protein | Change in total protein on study | 12 months minus baseline values | 
| eGFR | Changes in estimated (via CKD-EPI) Glomerular Filtration Rate. | 12 months minus baseline values | 
| UACR | change in urinary albumin to creatinine ratio on study. | 12 months minus baseline values | 
| KDQOL-Symptom/Problem | Changes on study of symptom/problem list from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values | 
| KDQOL-EKD | Changes in effects of kidney disease score from quality of life (KDQOL). Changes on study of effect of kidney disease from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values | 
| KDQOL-BKD | Change on study of burden of kidney disease score from KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values | 
| KDQOL-SF12 Physical Score | Changes on study of SF12 physical quality of life scale from the KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values | 
| KDQOL-SF12 Mental Score | Change on study of SF12 mental quality of life scale from the KDQOL-36 Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values | 
| 8-Item Morisky Score | Change in Morisky total score on study.The 8-item Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The Scale of the total score ranges from 0 to 8. We only report a total score. For a reported scale, Zero reflects worse medication adherence and 8 reflects better medication adherence We didn't combine the subscales to compute a total score, but the total score does reflect the number of individual items that were endorsed. | 12 months minus baseline values | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Native American, Patient Activation Measure, Community Health Representative, Home base, Diabetes, Point of care testing, Patient preferences