Trial Outcomes & Findings for Home-base Kidney Care in Zuni Indians (NCT NCT02915029)

NCT ID: NCT02915029

Last Updated: 2019-12-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: 12 months follow-up minus baseline values
• Results posted on: 2019-12-04

Participant Flow

Unit of analysis: Number of home visit

Participant milestones

Measure	Education and Lifestyle Coaching 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.	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.
Overall Study STARTED	63 24	62 0
Overall Study COMPLETED	50 24	48 0
Overall Study NOT COMPLETED	13 0	14 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-base Kidney Care in Zuni Indians

Baseline characteristics by cohort

Measure	Education and Lifestyle Coaching n=63 Participants 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.	Usual Care (UC) Control Arm n=62 Participants 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 n=125 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 11 • n=5 Participants	48 years STANDARD_DEVIATION 12 • n=7 Participants	47 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Patient Activation Measure - Total Score	60.7 Score STANDARD_DEVIATION 20.5 • n=5 Participants	65.1 Score STANDARD_DEVIATION 14.6 • n=7 Participants	62.9 Score STANDARD_DEVIATION 17.8 • n=5 Participants
Patient activation level >3	43 participants with diabetes n=5 Participants	52 participants with diabetes n=7 Participants	95 participants with diabetes n=5 Participants
Systolic Blood Pressure	129 mm Hg STANDARD_DEVIATION 17 • n=5 Participants	132 mm Hg STANDARD_DEVIATION 19 • n=7 Participants	130 mm Hg STANDARD_DEVIATION 18 • n=5 Participants
Diastolic Blood Pressure	83 mm Hg STANDARD_DEVIATION 13 • n=5 Participants	85 mm Hg STANDARD_DEVIATION 13 • n=7 Participants	84 mm Hg STANDARD_DEVIATION 13 • n=5 Participants
HbA1c	7.5 percentage STANDARD_DEVIATION 2.6 • n=5 Participants	7.5 percentage STANDARD_DEVIATION 2.3 • n=7 Participants	7.5 percentage STANDARD_DEVIATION 2.5 • n=5 Participants
Hypertension	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Diabetes status	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
High School Graduate	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
BMI	32 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	32 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants
Serum Total Protein	7.7 g/dl STANDARD_DEVIATION 0.6 • n=5 Participants	7.6 g/dl STANDARD_DEVIATION 0.6 • n=7 Participants	7.7 g/dl STANDARD_DEVIATION 0.6 • n=5 Participants
Serum Cholesterol	201 mg/dl STANDARD_DEVIATION 58 • n=5 Participants	181 mg/dl STANDARD_DEVIATION 38 • n=7 Participants	191 mg/dl STANDARD_DEVIATION 49 • n=5 Participants
Serum LDL Cholesterol	117 mg/dl STANDARD_DEVIATION 42 • n=5 Participants	109 mg/dl STANDARD_DEVIATION 32 • n=7 Participants	113 mg/dl STANDARD_DEVIATION 37 • n=5 Participants
Serum HDL Cholesterol	46 mg/dl n=5 Participants	50 mg/dl n=7 Participants	48 mg/dl n=5 Participants
Serum Triglycerides	139 mg/dl n=5 Participants	133 mg/dl n=7 Participants	136 mg/dl n=5 Participants
eGFR	105 mL/min/1.73 m^2 STANDARD_DEVIATION 31 • n=5 Participants	101 mL/min/1.73 m^2 STANDARD_DEVIATION 29 • n=7 Participants	103 mL/min/1.73 m^2 STANDARD_DEVIATION 30 • n=5 Participants
UACR	139 mg/g n=5 Participants	190 mg/g n=7 Participants	155 mg/g n=5 Participants
hsCRP	3.8 mg/L n=5 Participants	2.6 mg/L n=7 Participants	2.9 mg/L n=5 Participants
KDQOL-SP	86.4 points STANDARD_DEVIATION 11.2 • n=5 Participants	86.6 points STANDARD_DEVIATION 14.4 • n=7 Participants	86.5 points STANDARD_DEVIATION 12.9 • n=5 Participants
KDQOL-EKD	92.7 points STANDARD_DEVIATION 7.3 • n=5 Participants	93.2 points STANDARD_DEVIATION 12.0 • n=7 Participants	92.9 points STANDARD_DEVIATION 9.9 • n=5 Participants
KDQOL-BKD	70.3 points STANDARD_DEVIATION 20.5 • n=5 Participants	74.3 points STANDARD_DEVIATION 23.8 • n=7 Participants	72.3 points STANDARD_DEVIATION 22.2 • n=5 Participants
KDQOL-SF12 Physical Score	45.5 points STANDARD_DEVIATION 9.5 • n=5 Participants	45.4 points STANDARD_DEVIATION 8.5 • n=7 Participants	45.5 points STANDARD_DEVIATION 9.0 • n=5 Participants
KDQOL-SF12 Mental	47.4 points STANDARD_DEVIATION 9.6 • n=5 Participants	51.2 points STANDARD_DEVIATION 10 • n=7 Participants	49.3 points STANDARD_DEVIATION 9.8 • n=5 Participants
Morisky Score	5.4 Scores on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	4.6 Scores on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	5.0 Scores on a scale STANDARD_DEVIATION 2.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Patient Activation Measure (PAM) -13 Item Questionnaire	9.1 points Standard Deviation 26.0	-1.4 points Standard Deviation 15.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Patient Activation Measure (PAM) Level Greater Than 2	44 Participants	33 Participants

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in clinical values

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
A1c	-0.5 percentage Standard Deviation 1.4	0.1 percentage Standard Deviation 1.4

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in diastolic blood pressure on study.

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Diastolic Blood Pressure	-0.1 mm Hg Standard Deviation 12.8	0.2 mm Hg Standard Deviation 14.9

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in Systolic blood pressure over study.

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Systolic Blood Pressure	3.4 mm Hg Standard Deviation 19.0	5.2 mm Hg Standard Deviation 19.0

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in the value of body mass index (BMI)

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Body Mass Index	-1.3 kg/m^2 Standard Deviation 2.1	-0.2 kg/m^2 Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in serum LDL cholesterol on study

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Low-density Lipoprotein LDL Cholesterol	-12.4 mg/dl Standard Deviation 41.2	-4.9 mg/dl Standard Deviation 36.5

SECONDARY outcome

Timeframe: 12 months minus baseline values

Change in serum HDL cholesterol on study

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
High-density Lipoprotein HDL Cholesterol	3.5 mg/dl Interval -1.8 to 11.8	1.5 mg/dl Interval -6.0 to 4.0

SECONDARY outcome

Timeframe: 12 months minus baseline values

Change in serum triglycerides on study

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Triglycerides	-8.0 mg/dl Interval -46.0 to 30.5	-8.5 mg/dl Interval -32.8 to 23.3

SECONDARY outcome

Timeframe: 12 months minus baseline values

Change in total cholesterol on study

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
Serum Total Cholesterol	-19 mg/dl Standard Deviation 54.3	-4.5 mg/dl Standard Deviation 44.5

SECONDARY outcome

Timeframe: 12 months minus baseline values

Changes in the serum c-reactive protein on study

Outcome measures

Measure	Education and Lifestyle Coaching n=47 Participants 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.	Usual Care (UC) Control Arm n=46 Participants 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.
High Sensitive C-reactive Protein-hsCRP	-1.5 mg/L Interval -5.8 to 0.0	1.7 mg/L Interval -0.5 to 6.5

SECONDARY outcome

Timeframe: 12 months minus baseline values

Change in total protein on study

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=47 Participants 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.
Serum Total Protein	-0.2 g/dl Standard Deviation 0.4	-0.1 g/dl Standard Deviation 0.4

SECONDARY outcome

Timeframe: 12 months minus baseline values

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

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
eGFR	-5.2 mL/min/1.73 m2 Standard Deviation 14.2	-9.6 mL/min/1.73 m2 Standard Deviation 12.2

SECONDARY outcome

Timeframe: 12 months minus baseline values

change in urinary albumin to creatinine ratio on study.

Outcome measures

Measure	Education and Lifestyle Coaching n=50 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
UACR	-45 mg/g Interval -176.0 to 13.3	17.5 mg/g Interval -62.5 to 359.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=47 Participants 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.	Usual Care (UC) Control Arm n=47 Participants 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.
KDQOL-Symptom/Problem	0.1 points Standard Deviation 13.7	2.7 points Standard Deviation 11.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=49 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
KDQOL-EKD	3.2 score on a scale Standard Deviation 8.0	2.9 score on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=49 Participants 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.	Usual Care (UC) Control Arm n=47 Participants 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.
KDQOL-BKD	14.8 score on a scale Standard Deviation 22.1	2.3 score on a scale Standard Deviation 31.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=49 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
KDQOL-SF12 Physical Score	2.1 score on a scale Standard Deviation 9.4	0.8 score on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=49 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
KDQOL-SF12 Mental Score	7.5 score on a scale Standard Deviation 11.0	-0.2 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Lifestyle Coaching n=49 Participants 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.	Usual Care (UC) Control Arm n=48 Participants 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.
8-Item Morisky Score	5.4 score on a scale Standard Deviation 2.3	4.6 score on a scale Standard Deviation 2.3

Adverse Events

Educational Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care - Control

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Educational Intervention n=63 participants at risk Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence	Usual Care - Control n=62 participants at risk 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.
General disorders Death	1.6% 1/63 • 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.	4.8% 3/62 • 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.

Other adverse events

Measure	Educational Intervention n=63 participants at risk Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence	Usual Care - Control n=62 participants at risk 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.
General disorders Other adverse event	— 0/0 • 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.	— 0/0 • 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.

Additional Information

Dr Vallabh Shah

University of New Mexico

Phone: 505-272-9615

Email: vshah@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place