HBKC: Home-base Kidney Care in Zuni Indians

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT02915029
• Collaborator: Zuni Tribal Administration (Other), Zuni comprehensive Community Health Center, Indian Health Services (Other)
• Enrollment: 125
• Arms: 2
• Duration (Months): 32

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Other: Educational and lifestyle coaching	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education and Lifestyle Coaching 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; 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.
No Intervention: Usual care (UC) control arm 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.

Outcome Measures

Primary Outcome Measures

1. Patient Activation Measure (PAM) -13 Item Questionnaire [12 months follow-up minus baseline values]

   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.

2. Patient Activation Measure (PAM) Level Greater Than 2 [12 months follow-up]

   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.

Secondary Outcome Measures

1. A1c [12 months minus baseline values]

   Changes in clinical values

2. Diastolic Blood Pressure [12 months minus baseline values]

   Changes in diastolic blood pressure on study.

3. Systolic Blood Pressure [12 months minus baseline values]

   Changes in Systolic blood pressure over study.

4. Body Mass Index [12 months minus baseline values]

   Changes in the value of body mass index (BMI)

5. Low-density Lipoprotein LDL Cholesterol [12 months minus baseline values]

   Changes in serum LDL cholesterol on study

6. High-density Lipoprotein HDL Cholesterol [12 months minus baseline values]

   Change in serum HDL cholesterol on study

7. Triglycerides [12 months minus baseline values]

   Change in serum triglycerides on study

8. Serum Total Cholesterol [12 months minus baseline values]

   Change in total cholesterol on study

9. High Sensitive C-reactive Protein-hsCRP [12 months minus baseline values]

   Changes in the serum c-reactive protein on study

10. Serum Total Protein [12 months minus baseline values]

    Change in total protein on study

11. eGFR [12 months minus baseline values]

    Changes in estimated (via CKD-EPI) Glomerular Filtration Rate.

12. UACR [12 months minus baseline values]

    change in urinary albumin to creatinine ratio on study.

13. KDQOL-Symptom/Problem [12 months minus baseline values]

    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.

14. KDQOL-EKD [12 months minus baseline values]

    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.

15. KDQOL-BKD [12 months minus baseline values]

    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.

16. KDQOL-SF12 Physical Score [12 months minus baseline values]

    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.

17. KDQOL-SF12 Mental Score [12 months minus baseline values]

    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.

18. 8-Item Morisky Score [12 months minus baseline values]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of New Mexico
• Zuni Tribal Administration
• Zuni comprehensive Community Health Center, Indian Health Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• MacCluer JW, Scavini M, Shah VO, Cole SA, Laston SL, Voruganti VS, Paine SS, Eaton AJ, Comuzzie AG, Tentori F, Pathak DR, Bobelu A, Bobelu J, Ghahate D, Waikaniwa M, Zager PG. Heritability of measures of kidney disease among Zuni Indians: the Zuni Kidney Project. Am J Kidney Dis. 2010 Aug;56(2):289-302. doi: 10.1053/j.ajkd.2010.03.012. Epub 2010 Jun 19.
• Nelson RG, Pankratz VS, Ghahate DM, Bobelu J, Faber T, Shah VO. Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial. Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1801-1809. doi: 10.2215/CJN.06910618. Epub 2018 Nov 15.
• Newman S, Cheng T, Ghahate DM, Bobelu J, Sandy P, Faber T, Shah VO. Assessing knowledge and attitudes of diabetes in Zuni Indians using a culture-centered approach. PLoS One. 2014 Jun 11;9(6):e99614. doi: 10.1371/journal.pone.0099614. eCollection 2014.
• Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015. Review.
• Shah VO, Ghahate DM, Bobelu J, Sandy P, Newman S, Helitzer DL, Faber T, Zager P. Identifying barriers to healthcare to reduce health disparity in Zuni Indians using focus group conducted by community health workers. Clin Transl Sci. 2014 Feb;7(1):6-11. doi: 10.1111/cts.12127. Epub 2013 Nov 8.

• Responsible Party: Vallabh O Shah, Professor, University of New Mexico
• ClinicalTrials.gov Identifier: NCT02915029
• Other Study ID Numbers: 10-249 -sub study HBKC
• First Posted: Sep 26, 2016
• Last Update Posted: Dec 4, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Vallabh O Shah, Professor, University of New Mexico: Native American; Community Health Representative; Home base; Diabetes; Point of care testing; Patient Activation Measure; Patient preferences
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

Participant Flow

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Period Title: Overall Study
STARTED	63	62
COMPLETED	50	48
NOT COMPLETED	13	14

Baseline Characteristics

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm	Total
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.	Total of all reporting groups
Overall Participants	63	62	125
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (11)	48 (12)	47 (12)
Sex: Female, Male (Count of Participants)
Female	31 49.2%	26 41.9%	57 45.6%
Male	32 50.8%	36 58.1%	68 54.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	63 100%	62 100%	125 100%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	63 100%	62 100%	125 100%
Patient Activation Measure - Total Score (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	60.7 (20.5)	65.1 (14.6)	62.9 (17.8)
Patient activation level >3 (participants with diabetes) [Number]
Number [participants with diabetes]	43 68.3%	52 83.9%	95 76%
Systolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	129 (17)	132 (19)	130 (18)
Diastolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	83 (13)	85 (13)	84 (13)
HbA1c (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	7.5 (2.6)	7.5 (2.3)	7.5 (2.5)
Hypertension (Count of Participants)
Count of Participants [Participants]	36 57.1%	42 67.7%	78 62.4%
Diabetes status (Count of Participants)
Count of Participants [Participants]	33 52.4%	39 62.9%	72 57.6%
High School Graduate (Count of Participants)
Count of Participants [Participants]	41 65.1%	37 59.7%	78 62.4%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32 (8)	32 (7)	32 (8)
Serum Total Protein (g/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dl]	7.7 (0.6)	7.6 (0.6)	7.7 (0.6)
Serum Cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	201 (58)	181 (38)	191 (49)
Serum LDL Cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	117 (42)	109 (32)	113 (37)
Serum HDL Cholesterol (mg/dl) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dl]	46	50	48
Serum Triglycerides (mg/dl) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dl]	139	133	136
eGFR (mL/min/1.73 m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min/1.73 m^2]	105 (31)	101 (29)	103 (30)
UACR (mg/g) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/g]	139	190	155
hsCRP (mg/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/L]	3.8	2.6	2.9
KDQOL-SP (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	86.4 (11.2)	86.6 (14.4)	86.5 (12.9)
KDQOL-EKD (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	92.7 (7.3)	93.2 (12.0)	92.9 (9.9)
KDQOL-BKD (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	70.3 (20.5)	74.3 (23.8)	72.3 (22.2)
KDQOL-SF12 Physical Score (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	45.5 (9.5)	45.4 (8.5)	45.5 (9.0)
KDQOL-SF12 Mental (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	47.4 (9.6)	51.2 (10)	49.3 (9.8)
Morisky Score (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	5.4 (2.3)	4.6 (2.3)	5.0 (2.3)

Outcome Measures

1. Primary Outcome

Title	Patient Activation Measure (PAM) -13 Item Questionnaire
Description	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.
Time Frame	12 months follow-up minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [points]	9.1 (26.0)	-1.4 (15.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education and Lifestyle Coaching
	Comments	Group 1(usual care) is the comparison group, group 2 is the intervention group.
	Type of Statistical Test	Superiority
	Comments	The primary hypothesis being tested was that the intervention will increase patient activation.
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANCOVA
	Comments	Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 1.9 to 15.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.
Other Statistical Analysis		Applied generalized estimating equations (GEE) to account for within family (household) clustering.

2. Primary Outcome

Title	Patient Activation Measure (PAM) Level Greater Than 2
Description	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.
Time Frame	12 months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Count of Participants [Participants]	44 69.8%	33 53.2%

3. Secondary Outcome

Title	A1c
Description	Changes in clinical values
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [percentage]	-0.5 (1.4)	0.1 (1.4)

4. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Changes in diastolic blood pressure on study.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [mm Hg]	-0.1 (12.8)	0.2 (14.9)

5. Secondary Outcome

Title	Systolic Blood Pressure
Description	Changes in Systolic blood pressure over study.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [mm Hg]	3.4 (19.0)	5.2 (19.0)

6. Secondary Outcome

Title	Body Mass Index
Description	Changes in the value of body mass index (BMI)
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [kg/m^2]	-1.3 (2.1)	-0.2 (1.9)

7. Secondary Outcome

Title	Low-density Lipoprotein LDL Cholesterol
Description	Changes in serum LDL cholesterol on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [mg/dl]	-12.4 (41.2)	-4.9 (36.5)

8. Secondary Outcome

Title	High-density Lipoprotein HDL Cholesterol
Description	Change in serum HDL cholesterol on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Inter-Quartile Range) [mg/dl]	3.5	1.5

9. Secondary Outcome

Title	Triglycerides
Description	Change in serum triglycerides on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Median (Inter-Quartile Range) [mg/dl]	-8.0	-8.5

10. Secondary Outcome

Title	Serum Total Cholesterol
Description	Change in total cholesterol on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [mg/dl]	-19 (54.3)	-4.5 (44.5)

11. Secondary Outcome

Title	High Sensitive C-reactive Protein-hsCRP
Description	Changes in the serum c-reactive protein on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	47	46
Mean (Inter-Quartile Range) [mg/L]	-1.5	1.7

12. Secondary Outcome

Title	Serum Total Protein
Description	Change in total protein on study
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	47
Mean (Standard Deviation) [g/dl]	-0.2 (0.4)	-0.1 (0.4)

13. Secondary Outcome

Title	eGFR
Description	Changes in estimated (via CKD-EPI) Glomerular Filtration Rate.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Mean (Standard Deviation) [mL/min/1.73 m2]	-5.2 (14.2)	-9.6 (12.2)

14. Secondary Outcome

Title	UACR
Description	change in urinary albumin to creatinine ratio on study.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	50	48
Median (Inter-Quartile Range) [mg/g]	-45	17.5

15. Secondary Outcome

Title	KDQOL-Symptom/Problem
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	47	47
Mean (Standard Deviation) [points]	0.1 (13.7)	2.7 (11.5)

16. Secondary Outcome

Title	KDQOL-EKD
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	49	48
Mean (Standard Deviation) [score on a scale]	3.2 (8.0)	2.9 (8.8)

17. Secondary Outcome

Title	KDQOL-BKD
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	49	47
Mean (Standard Deviation) [score on a scale]	14.8 (22.1)	2.3 (31.9)

18. Secondary Outcome

Title	KDQOL-SF12 Physical Score
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	49	48
Mean (Standard Deviation) [score on a scale]	2.1 (9.4)	0.8 (10.6)

19. Secondary Outcome

Title	KDQOL-SF12 Mental Score
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	49	48
Mean (Standard Deviation) [score on a scale]	7.5 (11.0)	-0.2 (10.0)

20. Secondary Outcome

Title	8-Item Morisky Score
Description	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.
Time Frame	12 months minus baseline values

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education and Lifestyle Coaching	Usual Care (UC) Control Arm
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence 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.	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.
Measure Participants	49	48
Mean (Standard Deviation) [score on a scale]	5.4 (2.3)	4.6 (2.3)

Adverse Events

Time Frame	No adverse event data were collected over 12 month period of study intervention. There was no active monitoring for adverse events. However, upon completion of the study, our efforts to identify the reasons that led to study attrition, we found that a number of participants had passed away. None of the deaths were deemed to be a result of study participation.
Arm/Group Title	Educational Intervention		Usual Care - Control
Arm/Group Description	Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence		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.
All Cause Mortality
	Educational Intervention		Usual Care - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)		3/62 (4.8%)
Serious Adverse Events
	Educational Intervention		Usual Care - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)		3/62 (4.8%)
General disorders
Death	1/63 (1.6%)		3/62 (4.8%)
Other (Not Including Serious) Adverse Events
	Educational Intervention		Usual Care - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
General disorders
Other adverse event	0/0 (NaN)	0	0/0 (NaN)	0

Limitations/Caveats

The study took place in one Indian reservation in rural New Mexico. The results might be different for people in other places. The team didn't look at which parts of the program might explain the changes they found.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.