Home-base Kidney Care in Zuni Indians

Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02915029

Acronym

HBKC

Enrollment

125

Registered

2016-09-26

Start date

2013-10-31

Completion date

2016-06-30

Last updated

2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Native American, Community Health Representative, Home base, Diabetes, Point of care testing, Patient Activation Measure, Patient preferences

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.

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.

Interventions

OTHEREducational 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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
Systolic Blood Pressure	12 months minus baseline values	Changes in Systolic blood pressure over study.
Body Mass Index	12 months minus baseline values	Changes in the value of body mass index (BMI)
Low-density Lipoprotein LDL Cholesterol	12 months minus baseline values	Changes in serum LDL cholesterol on study
High-density Lipoprotein HDL Cholesterol	12 months minus baseline values	Change in serum HDL cholesterol on study
Triglycerides	12 months minus baseline values	Change in serum triglycerides on study
Serum Total Cholesterol	12 months minus baseline values	Change in total cholesterol on study
High Sensitive C-reactive Protein-hsCRP	12 months minus baseline values	Changes in the serum c-reactive protein on study
Serum Total Protein	12 months minus baseline values	Change in total protein on study
A1c	12 months minus baseline values	Changes in clinical values
UACR	12 months minus baseline values	change in urinary albumin to creatinine ratio on study.
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.
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.
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.
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.
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.
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.
eGFR	12 months minus baseline values	Changes in estimated (via CKD-EPI) Glomerular Filtration Rate.
Diastolic Blood Pressure	12 months minus baseline values	Changes in diastolic blood pressure on study.

Participant flow

Participants by arm

Arm	Count
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.	63
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.	62
Total	125

Baseline characteristics

Characteristic	Education and Lifestyle Coaching	Total	Usual Care (UC) Control Arm
Age, Continuous	46 years STANDARD_DEVIATION 11	47 years STANDARD_DEVIATION 12	48 years STANDARD_DEVIATION 12
BMI	32 kg/m^2 STANDARD_DEVIATION 8	32 kg/m^2 STANDARD_DEVIATION 8	32 kg/m^2 STANDARD_DEVIATION 7
Diabetes status	33 Participants	72 Participants	39 Participants
Diastolic Blood Pressure	83 mm Hg STANDARD_DEVIATION 13	84 mm Hg STANDARD_DEVIATION 13	85 mm Hg STANDARD_DEVIATION 13
eGFR	105 mL/min/1.73 m^2 STANDARD_DEVIATION 31	103 mL/min/1.73 m^2 STANDARD_DEVIATION 30	101 mL/min/1.73 m^2 STANDARD_DEVIATION 29
HbA1c	7.5 percentage STANDARD_DEVIATION 2.6	7.5 percentage STANDARD_DEVIATION 2.5	7.5 percentage STANDARD_DEVIATION 2.3
High School Graduate	41 Participants	78 Participants	37 Participants
hsCRP	3.8 mg/L	2.9 mg/L	2.6 mg/L
Hypertension	36 Participants	78 Participants	42 Participants
KDQOL-BKD	70.3 points STANDARD_DEVIATION 20.5	72.3 points STANDARD_DEVIATION 22.2	74.3 points STANDARD_DEVIATION 23.8
KDQOL-EKD	92.7 points STANDARD_DEVIATION 7.3	92.9 points STANDARD_DEVIATION 9.9	93.2 points STANDARD_DEVIATION 12
KDQOL-SF12 Mental	47.4 points STANDARD_DEVIATION 9.6	49.3 points STANDARD_DEVIATION 9.8	51.2 points STANDARD_DEVIATION 10
KDQOL-SF12 Physical Score	45.5 points STANDARD_DEVIATION 9.5	45.5 points STANDARD_DEVIATION 9	45.4 points STANDARD_DEVIATION 8.5
KDQOL-SP	86.4 points STANDARD_DEVIATION 11.2	86.5 points STANDARD_DEVIATION 12.9	86.6 points STANDARD_DEVIATION 14.4
Morisky Score	5.4 Scores on a scale STANDARD_DEVIATION 2.3	5.0 Scores on a scale STANDARD_DEVIATION 2.3	4.6 Scores on a scale STANDARD_DEVIATION 2.3
Patient activation level >3	43 participants with diabetes	95 participants with diabetes	52 participants with diabetes
Patient Activation Measure - Total Score	60.7 Score STANDARD_DEVIATION 20.5	62.9 Score STANDARD_DEVIATION 17.8	65.1 Score STANDARD_DEVIATION 14.6
Race (NIH/OMB) American Indian or Alaska Native	63 Participants	125 Participants	62 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	63 Participants	125 Participants	62 Participants
Serum Cholesterol	201 mg/dl STANDARD_DEVIATION 58	191 mg/dl STANDARD_DEVIATION 49	181 mg/dl STANDARD_DEVIATION 38
Serum HDL Cholesterol	46 mg/dl	48 mg/dl	50 mg/dl
Serum LDL Cholesterol	117 mg/dl STANDARD_DEVIATION 42	113 mg/dl STANDARD_DEVIATION 37	109 mg/dl STANDARD_DEVIATION 32
Serum Total Protein	7.7 g/dl STANDARD_DEVIATION 0.6	7.7 g/dl STANDARD_DEVIATION 0.6	7.6 g/dl STANDARD_DEVIATION 0.6
Serum Triglycerides	139 mg/dl	136 mg/dl	133 mg/dl
Sex: Female, Male Female	31 Participants	57 Participants	26 Participants
Sex: Female, Male Male	32 Participants	68 Participants	36 Participants
Systolic Blood Pressure	129 mm Hg STANDARD_DEVIATION 17	130 mm Hg STANDARD_DEVIATION 18	132 mm Hg STANDARD_DEVIATION 19
UACR	139 mg/g	155 mg/g	190 mg/g

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 63	3 / 62
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	1 / 63	3 / 62

Outcome results

Primary

Patient Activation Measure (PAM) -13 Item Questionnaire

Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group.

Time frame: 12 months follow-up minus baseline values

Arm	Measure	Value (MEAN)	Dispersion
Education and Lifestyle Coaching	Patient Activation Measure (PAM) -13 Item Questionnaire	9.1 points	Standard Deviation 26
Usual Care (UC) Control Arm	Patient Activation Measure (PAM) -13 Item Questionnaire	-1.4 points	Standard Deviation 15.3

Comparison: Group 1(usual care) is the comparison group, group 2 is the intervention group.p-value: 0.0195% CI: [1.9, 15.5]ANCOVA

Primary

Patient Activation Measure (PAM) Level Greater Than 2

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

Time frame: 12 months follow-up

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Education and Lifestyle Coaching	Patient Activation Measure (PAM) Level Greater Than 2	44 Participants
Usual Care (UC) Control Arm	Patient Activation Measure (PAM) Level Greater Than 2	33 Participants

Secondary

8-Item Morisky Score

Change in Morisky total score on study.The 8-item Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The Scale of the total score ranges from 0 to 8. We only report a total score. For a reported scale, * Zero reflects worse medication adherence and * 8 reflects better medication adherence We didn't combine the subscales to compute a total score, but the total score does reflect the number of individual items that were endorsed.