Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation
Phase: NA
Conditions: Chronic Kidney Diseases
Sponsor: University of New Mexico

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
Page 1 of 22
Revised: May 13, 20211
PROTOCOL TITLE: Tribal Home-Based Kidney Care Study
PRINCIPAL INVESTIGATOR:
Name: Vallabh (Raj) Shah
Department: Int Medicine and Biochemistry
Telephone Number: 505-272-9615
Email Address: vshah@salud.unm.edu
Name: Kevin English – Joint PI
Albuquerque Area Southwest Tribal Epidemiology Center, Albuquerque Area 
Indian Health Board, Inc. Albuquerque, NM
Telephone: 505-962-2602
Email Address: kenglish@aaihb.org
VERSION NUMBER: HBKC_003
DATE: 05/13/2021

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
Page 2 of 22
Revised: May 13, 20211
Table of Contents
1.0
Objectives* ...............................................................................................................3
2.0
Background*.............................................................................................................4
3.0
Inclusion and Exclusion Criteria* ............................................................................7
4.0
Study-Wide Number of Subjects*............................................................................8
5.0
Study-Wide Recruitment Methods* .........................................................................8
6.0
Multi-Site Research* ................................................................................................9
7.0
Study Timelines*......................................................................................................9
8.0
Study Endpoints*......................................................................................................9
9.0
Procedures Involved* .............................................................................................10
10.0
Data and Specimen Banking*.................................................................................13
11.0
Data Management*.................................................................................................13
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*.........................14
13.0
Withdrawal of Subjects*.........................................................................................14
14.0
Risks to Subjects*...................................................................................................14
15.0
Potential Benefits to Subjects* ...............................................................................15
16.0
Vulnerable Populations*.........................................................................................15
17.0
Community-Based Participatory Research*...........................................................15
18.0
Sharing of Results with Subjects* ..........................................................................15
19.0
Setting.....................................................................................................................15
20.0
Resources Available ...............................................................................................16
21.0
Prior Approvals.......................................................................................................17
22.0
Recruitment Methods..............................................................................................17
23.0
Local Number of Subjects ......................................................................................19
24.0
Confidentiality ........................................................................................................19
25.0
Provisions to Protect the Privacy Interests of Subjects ..........................................19
26.0
Compensation for Research-Related Injury............................................................20
27.0
Economic Burden to Subjects.................................................................................20
28.0
Consent Process......................................................................................................20
29.0
Process to Document Consent in Writing...............................................................22
30.0
Drugs or Devices ....................................................................................................22

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Revised: May 13, 20211
1.
Objectives*
Recently, through Patient Center Outcomes Research Institute (PCORI) funded home 
based kidney care (HBKC), UNMHSC IRB 10-249, we (Shah) established a model for 
delivering kidney care in Zuni Indians with the following innovations: (1) it is the first 
HBKC system for the diagnosis and management of CKD in high risk minority populations 
that was designed in collaboration with tribal community leadership and local Indian 
Health Services (IHS) providers; (2) it prioritizes patient preferences in their health care 
by using individualized curricula for CKD intervention; (3) it has as its primary outcomes 
patient activation measures and adherence; (4) it combines community health 
representatives (CHRs) with point of care (POC) technology and text messaging to deliver 
state-of-the-art care; (5) it incorporates the culture and traditions of the community, and (6) 
it employs a patient-centered approach leveraged with CHRs, IHS physicians, and 
expertise from an academic medical center.
The HBKC study demonstrated that many of the Zuni patients with diabetes and CKD 
experience significant stigmatization when they are diagnosed. We demonstrated that a 
home-based, CHR-implemented educational intervention using POC testing and 
individualized therapeutic goals significantly improves compliance with care and 
metabolic parameters relevant to CKD and diabetes, including microalbuminuria, A1C, 
and lipid concentrations.
In order to test the HBKC model used in Zuni Pueblo, our OBJECTIVE is to extend our 
culturally specific, CHR-led evidence-based community screening and intervention model 
into other high-risk communities of Native Americans in New Mexico. We are partnering 
with the Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC) and its 
parent organization the Albuquerque Area Indian Health Board, Inc. (AAIHB). Our 
proposed aims are to compare effectiveness of multidisciplinary HBKC interventions to 
bolster patient levels of kidney specific knowledge, self-efficacy and CKD self-
management, enabling Native Americans to carry out the recommendations in a culturally 
sensitive way.
Aim 1: Screen 600 participants from four different American Indian tribes in New Mexico 
utilizing Point Of Care (POC) testing, to identify incident cases of CKD and identify 
participants for the proposed study of HBKC;
Aim 2: Conduct a 12 month study of HBKC among 240 Native Americans randomized in 
a 1:1 allocation to HBKC group versus Delayed Intervention (DI) group to demonstrate 
improvement in Patient Activation Measures (PAM) and adherence to treatment. We will 
demonstrate that CKD clinical risk profiles will improve with HBKC as compared to DI at 
12 months and 4 months post intervention (16 months);
Aim 3: To demonstrate that HBKC will improve psychological factors that map onto 
important cultural variations in treatment efficacy and health outcomes. Specifically, we 
will show improvement in potential mediators (treatment engagement, self-efficacy, 
coping and increased knowledge) and moderators (stigma, and chronic stress, and 
depression) of health disparity and outcome.

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)  OR COVID-
19 related Addition: The aim of this addition activity is to track the impact of the COVID-
19 epidemic on participants with diabetes and chronic kidney disease (CKD). We are 
requesting a modification to the HBKC Study protocol to expand data currently collected 
from study participants to include data in the following domains linked to the COVID-19 
epidemic: symptoms of COVID-19 disease, access to healthcare, and impact on health 
related behaviors (such as medication adherence, physical activity, dietary behaviors, 
smoking, and alcohol use).
Specific Aims
Aim 1. Develop a phone-based and or mail based survey to understand the impact of 
COVID19 on patient-reported outcomes for adults with diabetes and CKD.
Aim 2. Test the feasibility and acceptability of this phone-based and or mail based survey 
in the HBKC cohort.
2.
Background*
Health Promotion: The Institute of Medicine (IOM) landmark report, Unequal Treatment, 
provides compelling evidence that racial/ethnic disparities persist in medical care for a 
number of health conditions and services including chronic kidney disease (CKD) 1. 
Furthermore, the IOM identified America’s top 100 priorities for comparative 
effectiveness research1. Among the top 25 were the following two priorities that will be 
directly addressed by our current protocol: (#15) compare the effectiveness of various 
strategies (e.g., clinical interventions, selected social interventions, combined clinical and 
social interventions) to prevent chronic disease in at-risk populations such as the urban 
poor and American Indians (AIs), and (#22) compare the effectiveness of interventions 
(e.g., community-based multi-level interventions, simple health education, usual care) to 
reduce health disparities.
Furthermore, Healthy People 2020 identifies elimination of health disparities as an 
urgent need and features 467 science-based objectives and 10 Leading Health Indicators to 
address disparities2. This protocol will address three of the ten Leading Heath Indicators; 
including clinical preventive services such as routine disease screening, healthcare access 
and health activities / behaviors including physical activity, over-weight and obesity. Given 
the existence of firmly-entrenched and rapidly increasing health disparities, novel 
approaches are needed to improve the health of socio-economically disadvantaged 
minorities including American Indian communities. One innovative approach is to build 
community capacity to promote community-wide health activities and campaigns for 
healthier lifestyles2. Community leaders can lead the way by forming alliances between 
tribal programs, schools, youth groups, elders and traditional healers to advocate for 
community-friendly health programs, and by supporting health policies and programs that 
respect values and culture. Our protocol builds upon a strong existing partnership between 
Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC), its parent 
organization the Albuquerque Area Indian Health Board, Inc. (AAIHB), –four tribal 
communities in the IHS Albuquerque Area, and the University of New Mexico Health 
Sciences Center to address paramount chronic disease priorities in the community.

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Disruptive Innovation in Health Care: Significant changes are occurring throughout 
the healthcare industry. As hospitals and health systems develop their strategies, they need 
to determine how to adapt to these changes to be successful in an environment that is 
moving from fee-for-service payments to pay-for-performance models. Our proposal is 
engaged in disruptive innovation - a term coined by C Christensen and K Clark3. Disruptive 
innovation can transform an existing care delivery models or create a new health care 
models by making processes simpler and improving access. The patient activation as the 
primary out-come of our protocol focuses on engaging patients in their healthcare decisions 
whereby we will use a home-based kidney care (HBKC) model delivered by tribal 
community health workers to give us and patients access to patients' individual health 
information at the point of care. The HBKC model will help patients visualize their 
condition and treatment options and will encourage their involvement in their own care. 
For example, for a patient with diabetes or CKD, the tool would use the patient's data to 
estimate the likelihood of developing other health complications and the likelihood of 
different interventions to prevent these complications. The HBKC model “helps the patient 
understand what the patient's role is in shared accountability in a way that's not just general 
statistics; it looks at what is patient risk based on their data”. It makes it more real, and the 
information more accessible. It helps take the dialogue in joint treatment planning between 
the tribal community health worker, commonly referred to as community health 
representatives (CHRs), and the patient to another level. Our disruptive innovations of 
HBKC delivered by CHRs with POC testing and patient preferences uproot existing 
systems in favor of new approaches that simplify processes and reach new understanding 
of patient care. 
Chronic Disease Burden in Disparity Population of American Indians: The percentage of 
adults who do not participate in regular physical activity is higher among AIs (46%) than 
the US population as a whole (40%), and the prevalence of type II diabetes is 16.1% among 
AIs.8 Prevalence of proteinuria is also higher among AIs than among the white population9. 
Furthermore, the incidence rate of diabetes related End-Stage Renal Disease (ESRD) is 3.5 
times as high in AIs as in the general U.S. population10. AHRQ-funded research has shown 
that AIs with diabetes often face economic barriers to treatment and are reluctant to place 
their own medical needs over needs of family members. Other common barriers include: a 
distrust of insulin therapy; a preference for more familiar traditional remedies; and a 
fatalistic acceptance of the disease 11.
CKD is common, harmful, treatable and frequently unrecognized until its latter 
stages. CKD is a national health problem affecting over 31 million Americans 12 with 9 out 
of 10 people with stage 3 CKD unaware that they have it 13. Racial and ethnic groups such 
as AIs are at greater risk for kidney failure. The risk for AIs is 2 times as high relative to 
non-Hispanic Whites14. Nearly 600,000 of these patients are being treated for ESRD15. 
ESRD, a debilitating disease associated with decreased quality of life, resulted in Medicare 
costs of $29 billion (6.7% of total Medicare budget spent on less than 1% of the patient 
population)16. Delayed referral of patients with progressive loss of kidney function 
increases health expenditures17. Our protocol directly addresses this important disparity in 
chronic disease, with emphasis on improving patient activation and adherence to prevent 
progression of CKD. 

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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The prevalence of overweight, obesity and type II diabetes among the study 
population is disproportionately elevated.  Specifically, among AI adults age 18 and over 
in the Indian Health Service (IHS) Albuquerque Area, 51.0% have a BMI > 30, which 
significantly exceeds the rate of obesity observed nationally (35.3%) and the Healthy 
People 2020 target of 30.5%2,18.  Likewise, the rate of type II diabetes (22.8%) among the 
adult AI population in our area is almost three times the rate of the U.S. adult population 
(8.3%)19, and the age-adjusted diabetes mortality rate for AI/ANs was 104.7 per 100,000 
compared to 23.1 per 100,000 among non-Hispanic Whites (NHWs) in the region20.  At 
the same time, the median age of diagnosis of type 2 diabetes among AI adults was much 
younger (42.2 years) than the national average (53.8 years)18.  Poor management of type 2 
diabetes is also common among AIs in the IHS Albuquerque Area, where only 44% of AIs 
with type 2 diabetes had their blood pressure under control (130/80) and only 33% had 
ideal glycemic control (HgA1C less than 7.0)21.  AI adults in the IHS Albuquerque Area 
with type II diabetes also demonstrate extraordinarily high rates of chronic kidney disease 
(mean=16.9%, range by Tribe=10.0% - 38.3%), hypertension (mean= 69.4%, range by 
Tribe=65.3% - 75.7%), and BMI > 30 (mean=63.8%, range by Tribe=59.5% - 75.6%)18.  
Consequently, there is a critical need to intervene with AI in our service area to prevent 
complications such as CKD, slow the progression of CKD to ESRD, and improve the 
management of type 2 diabetes.
Innovation and Theoretical Aspects of Chronic Care Model: The Chronic Care Model 
(CCM) re-orients healthcare practice to promote a systematic, planned approach by 
emphasizing productive interactions between informed, activated patients, their families, 
and proactive healthcare teams.31 A central tenet of this concept is that healthcare workers 
cannot achieve optimum outcomes when working alone. Rather, desired outcomes are 
achieved when communities and healthcare organizations work together toward shared 
goals, as proposed in this application. Our innovative educational / behavioral HBKC 
intervention hinges on the coordination of four key elements: (1) delivering healthcare that 
incorporates collaborative communication within the healthcare team and emphasizes 
greater autonomy in care, adherence to the medical regimen, and patient-centered goal 
setting, all while retaining the ability to address the needs of patients, family members, the 
healthcare team, and/or the healthcare system; (2) providing innovative educational and 
organizational approaches, as well as behavior change strategies, that will enhance 
adherence; (3) addressing health beliefs that reduce adherence by over- or under-predicting 
maladaptive thoughts (e.g., catastrophizing, minimizing, cognitive dissonance, 
invincibility, or fatalism) or that interfere with lifestyle changes; and (4) using technology 
to address barriers to achieving desired health outcomes. The proposed HBKC model 
described in this protocol is innovative in the following ways: (1) it is the only home based 
paradigm that has resulted from active collaborations with tribal community leadership and 
local providers for the diagnosis and management of CKD; (2) it prioritizes patient 
preferences and uses individualized curricula for CKD intervention; (3) it includes Patient 
Activation Measures and adherence as primary outcomes; (4) it uses Community Health 
Representatives (CHRs), who are provided with state of the art tools to achieve the desired 
outcomes, such as POC technology, text messaging and telemedicine, ultimately delivering 
evidence-based care to a very high risk population in a cost efficient manner; (5) it 
incorporates the culture and tradition of the participants; and (6) it may serve as a model 

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Revised: May 13, 20211
for other racial and ethnic groups in rural and urban locations that suffer from health 
disparities.
Preliminary data / experience: PI, Shah as a health services researcher for more than 17yrs 
has been involved with the Zuni Kidney Project (ZKP) and the Zuni Health Initiative (ZHI) 
funded consecutively by NIH and PCORI (RO1DK49347, 5UO1 DK57300, RO1 
DK073665-01A1, 5UO1 DK066660, 2P20 RR016480 and 2P20 RR016480-09S1 - ARRA 
supplement, and PCORI)59-68. The ZKP conducted a population-based survey which 
demonstrated extremely high age-adjusted prevalence estimates for renal disease and 
related co-morbidities, including hypertension, obesity, T2D, albuminuria and low 
estimated glomerular filtration rate. The ZHI started in 2009 as an educational program to 
identify barriers to health care, evaluate knowledge and perception of diabetes and measure 
health literacy among Zuni Indians along with conducting patient activation in chronic 
diseases (obesity, diabetes, kidney disease) management. The PCORI funded pilot study 
of home-based kidney care is the latest on-going study of patient activation measure as 
primary outcome.
PCORI supported Home-base Kidney Care Study in Zuni Individuals with CKD: 
In our previous study of home-base diabetes care in Zuni, we demonstrated that an 
innovative, six month, patient-centered intervention of empowering T2D patients to 
become active participants in their care resulted in improved diabetes outcomes28. We 
reported increase in “patient activation measure (PAM)” by at least one level in 58% of 
T2D participants, while 40% of participants who started at higher baseline PAM score did 
not change. Six months after intervention, mean levels of A1C decreased by 0.7 ± 1.2%; 
fasting blood glucose by 24.0 ± 38.0 mg/dl; BMI by 1.5 ± 2.1 kg/m2; total cholesterol by 
12.0± 28.0 mg/dl; and tri-glycerides by 52.0 ± 71.0 mg/dl. All of these changes were 
statistically significant (p<0.05).
3.
Inclusion and Exclusion Criteria*
We will screen a total of 600 willing participants in four of the American Indian 
communities in New Mexico. We have presented the study to American Indian 
communities across New Mexico at meetings of the Albuquerque Area Indian Health 
Board, Inc. (AAIHB) Board of Directors and the Albuquerque Area Southwest Tribal 
Epidemiology Center (AASTEC) Executive Council.  Four communities expressed interest 
in the study and possessed the necessary criteria for inclusion – tribal leadership approval 
to participate, direct access to a local Tribal/IHS health facility, and a large enough 
population (2,000 + tribal members and >150 members with T2DM) to ensure that the 
study is sufficiently powered. These four communities include Acoma Pueblo, Laguna 
Pueblo, Jicarilla Apache and Santo Domingo (Kewa) Pueblo.  Formal documentation of 
tribal leadership approval from three of these communities have been obtained and the final 
supporting document will be submitted to the IRB upon receipt.  We will measure blood 
pressure, height, and weight and waist circumference. We will determine the albumin: 
creatinine ratio in a spot urine sample and measure HbA1c and serum creatinine to classify 
patient for CKD.

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Inclusion Criteria include: The study will incorporate male and female community 
members: (1) live in a household with  1 participant; (2) age 21 to 80 years; and (3) 
negative pregnancy test in women of child-bearing potential; diagnosed diabetics or HbA1c 
>7, (4) BMI >27 kg/m2 and UACR of >/= 30
Exclusion criteria include: (1) life expectancy < 1 year; (2) pregnancy or absence of reliable 
birth control in women of child-bearing potential; (3) malignancy except non-melanoma 
skin cancer; (4) blind; (5) ESRD and on dialysis; (6) kidney transplant recipient; and (7) 
unwilling or unable to give informed consent.
4.
Study-Wide Number of Subjects*
We will screen 600 participants from four different American Indian tribes in New Mexico 
to identify incident cases of CKD and identify participants for the proposed study of 
HBKC.
We will also conduct a randomized controlled trial of home based kidney care (HBKC) 
versus control delayed intervention (DI) in 240 of eligible participants who live in a 
household that has ≥ 1 participant with CKD.  We will randomize households in a 1:1 
allocation to HBKC vs control DI.  In the usual care arm we will measure blood pressure, 
height, and weight and waist circumference and determine the albumin: creatinine ratio in 
a spot urine sample and measure HbA1c and serum creatinine at the beginning and end of 
the 1-year intervention. In the HBKC and control arm we will measure the same variables 
plus lipid profiles and inflammatory markers at baseline, six months and 1 year.
Estimated number of potentially eligible study 
participants 
(describe 
how 
this 
number 
was 
determined [e.g., EHR, claims data, clinic logs, 
administrative data, other]):
Each Tribe’s population 
averages 2,000 members 
and as per IHS database, 
>150 participants with 
T2DM will be eligible 
for the study.
Total number of study participants expected to be 
screened:
600 (150 in each Tribe)
Total number of study participants expected to be 
eligible of those screened:
306
Target sample size (use same number stated in 
milestones):
240
If applicable, total number of practices/centers that 
will enroll participants:
4
Projected month first participant enrolled (month after 
project initiation):
3
Projected month last participant enrolled (month after 
project initiation):
20
Projected rate of enrollment (anticipated number 
enrolled per month of enrollment period):
75/month for screening. 
30/month 
for 
the 
intervention

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Revised: May 13, 20211
5.
Study-Wide Recruitment Methods*
We will use a combination of clinic and community-based approaches to inform Tribal 
members of the study.   We will utilize the IHS Diabetes Audit to identify patients who are 
likely to meet the study eligibility criteria (i.e., age 21 to 80 years; and diagnosed diabetics 
or HbA1c >7, UACR > 30 and BMI >27 kg/m2.).  These individual will receive a mailing 
with information about the study and a culturally appropriate brochure that highlights the 
relationship between diabetes and chronic kidney disease.  Two follow-up letters will be 
mailed in 3 week increments and the CHR will also make home visits to non-responsive 
individuals.  Clinic providers will also be encouraged to provide information about the 
study to potentially eligible tribal members who present at the clinic during the study period 
until full enrollment is achieved.  Community-based approaches to inform other Tribal 
members about the study will include community meetings, posters, health fairs, and 
notices in the tribal newspapers/newsletters.  As previously detailed, this study will employ 
a full-time CHR in each of the four participating Tribes, who will also serve as community-
based messengers about the study and will be available to answer specific questions that 
emerge from tribal members in real time.  
Study recruitment will proceed as follows within each selected Tribe. We will screen up to 
150 potential enrollees for participation from each Tribe (n=4) and gather baseline data.  
We will screen participants for the study by measuring BP, height, weight, HgA1C, urinary 
albumin to creatinine ratio, and serum creatinine. For patients who are eligible by 
screening, we will randomize them to either receive the intervention immediately or to 
receive it on a delayed timeline in a 1:1 ratio. We will continue enrollment and 
randomization until we have randomized 30 individuals into each treatment arm within 
each Tribe. The individuals in the immediate intervention group will participate in the 
intervention program while those in the delayed intervention group will continue with their 
typical care in year 1.  After the first 12 months, participants in the delayed intervention 
arm will be invited to continue in the study and will receive the same intervention as was 
supplied to participants randomized to the immediate intervention arm.
All participants participated in the screening will receive a $25 merchandise card and those 
that agree to participate in the study will receive payments of $50 at baseline, and $25 at 3 
months, 6 months, 9 months 12 months and 16 months of the intervention.
6.
Multi-Site Research*
Not Applicable
7.
Study Timelines*
The study will last 36 months (12 Quarters).
Study Activity
Q1
Q2
Q3
Q4
Q5
Q6
Q7
Q8
Q9
Q10
Q11
Q12
Formative Work, Prepare MOO, 
X

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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8.
Study Endpoints*
In order to evaluate the degree to which the HBKC model influences CKD risk profiles, 
and potential mediators and moderators, of health disparity and outcome we will conduct 
a randomized trial of our intervention. The study will be conducted within four Native 
American communities in the IHS Albuquerque Area. A randomized block experimental 
design will be employed. The households will serve as the blocks, and individual 
participants will be randomized to either the immediate or delayed intervention arms in a 
1:1 ratio.
Aim 1 – Primary outcome: The Patient Activation Measure (PAM) and adherence 
measures;
Aim 2 – Secondary outcome: Changes in clinical phenotypes, including UACR, A1c, 
body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids; 
Aim 3 – Secondary outcome: Changes in quantitative traits such as food intake and 
scores from mental-health, self-efficacy, and quality of life instruments.
9.
Procedures Involved*
Aim 1: Screen 600 participants from four different American Indian tribes in the 
Southwest to identify incident cases of CKD and identify participants for the 
proposed study of HBKC. We will hold education sessions throughout the participating 
communities, including health fairs, Senior and Wellness Centers, Tribal Buildings and 
IHS facility to update the community on our home-based kidney care study. During these 
meetings we will offer to screen participants and measure BP, height, weight, HbA1c, 
UACR, serum creatinine and compute eGFR. All recipients who are screened will be 
educated about diabetes, hypertension and heart disease and CKD and counseled 
concerning healthy life styles and referred to the tribal providers including IHS for 
appropriate primary care and nephrology follow-up.  The screening process will also help 
us identify potential participants for the study of HBKC, described in this application.
Aim 2: Conduct a 12 month study of HBKC among 240 Native Americans 
randomized in a 1:1 allocation to HBKC group versus Delayed Intervention (DI) 
Translate Materials, Obtain IRB 
Approval and CHR training
Community education
X
X
X
X
X
X
X
X
X
X
X
X
Recruitment and Screening
X
X
Enrollment and HBKC intervention
X
X
X
X
Enrollment and delayed group 
intervention
X
X
X
X
Post Intervention Follow-up
X
X
Analyze Data and Prepare 
Manuscripts
X
X
X
X
Disseminate Results
X

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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group to demonstrate improvement in Patient Activation Measures (PAM) and 
adherence to treatment. We will demonstrate that CKD clinical risk profiles will 
improve with HBKC as compared to DI at 12 months and 16 months post 
intervention:
Conduct a 12 month study of HBKC 
among 
240 
participants 
from 
approximately 
160 
households 
randomized in a 1:1 allocation of 
households to HBKC versus DI to 
demonstrate that patient activation 
measure and CKD risk profiles 
(microalbuminuria, 
A1c, 
fasting 
glucose, plasma lipids, inflammatory 
markers, body weight, BMI, and 
blood pressure) will improve with 
HBKC as compared to DI care among 
community members with the highly 
prevalent chronic condition of CKD. 
DI arm participants will be treated 
with 
usual 
care. 
Participants 
randomized to the waiting list will 
enter the intervention group 12 
months after entering the study. Both 
intervention groups will be followed 
longitudinally for total of 16 months.
Randomization: All participants who are eligible for the intervention after baseline testing 
and who consent to participate will receive either HBKC (intervention arm) or delayed 
intervention (control arm). A randomization list will be generated under the direction of 
Dr. Pankratz, the study’s lead statistician as outlined in the Statistical Considerations 
section below. The unit of randomization will be the household, and all consenting and 
eligible members within a given family will be randomized as a block to avoid cross-group 
contamination. Study staff will not know to which arm a given household will be 
randomized until after assignment has been made.
Study Testing: All participants will receive study testing at baseline, 6 and 12 months of 
intervention, as well as at post-intervention follow-up at 16 months as depicted in the table. 
Testing will occur in the morning after a 10 hour overnight fast and will be conducted at 
the clinic facility by certified study staff.  
Delayed Intervention: Participants randomized to the control group will receive standard 
lifestyle advice as determined by their provider. They will also attend one group class 
taught by CHRs in which they will learn basic information about diabetes prevention, 
weight loss, diet, and exercise consistent with current expert recommendations for a 
healthy lifestyle, including losing body weight, standard dietary recommendations to 
reduce calorie and fat intake, and performing at least 150 minutes of moderately vigorous 

PROTOCOL TITLE: Tribal Home-Based Kidney Care (HBKC) Study
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Revised: May 13, 20211
physical activity per week. DI participants will receive publicly-available literature that 
reinforces the information given in class, and they will have no other contact with study 
staff aside from during study data collection visits at baseline and 12 months. After the 
baseline visit, participants in the DI arm will receive usual care as provided by IHS and/ or 
other providing hospital. With the participant’s consent, all screening and follow-up lab 
studies will be shared with the participant’s primary care physician, and the primary care 
physician will be notified of any change in the participant’s clinical status as noted at the 
12 month follow-up visits.
Intervention Arm:  For this study, we will train a small and dedicated cadre of four CHRs 
to implement the home-based intervention. As tribal members themselves, CHRs are 
especially well suited to aid community members in offering health education and patient 
navigation services, as well as study specific information, while acknowledging and 
respecting important cultural considerations.  To promote consistent engagement between 
the CHRs and the study team, the program coordinator will conduct weekly web-based 
meetings with all 4 CHRs and will also conduct at least one monthly in-person visit with 
each participating Tribe throughout the intervention period.  These meetings will not only 
maintain rapport between the study team and these critical community stakeholders, but 
will also provide opportunities to offer technical support and quality control throughout the 
study. The weekly web-based meetings and monthly in-person visits will allow us to build 
a cohort effect among the CHRs working across 4 communities.  Meeting content will 
entail 1) review of data collection methods and feedback on any data entry errors noted 
through our data records checking, 2) refreshers on the study protocol, 3) reinforcement of 
procedures for maintaining participant confidentiality, 4) review of upcoming modules for 
home education sessions, 5) debriefing on successful strategies, lessons learned and 
challenges experienced, 6) troubleshooting any unexpected challenges and/or CHR 
burdens that emerge during the prior week; 7) offering tangible and social support to all 
CHRs; and 8) identification and replenishment of needed supplies and resources.
CHRs will make regularly scheduled home visits, described below, and they will have a 
laptop computer with internet access and telemedicine contact with study faculties for 
ongoing review of care plans, and management of hypertension, dyslipidemia, and CKD. 
In a collaborative manner, the participant and healthcare team will set appropriately 
realistic treatment goals.
All subjects randomized to the HBKC arm will be visited by a CHR in their home 
at least every two weeks for the duration of the 12 month intervention. All enrolled 
members of a household unit will attend these visits. Each CHR will be responsible for all 
eligible participants and up to 60 home visits per month, although this latter estimate is 
high given that rolling enrollment will occur over a 12 month period.  Each visit will last 
30 minutes to one hour and will cover curriculum materials agreed upon by the study team 
and prioritized by the participants. Household visits will occur after-hours if necessary to 
maximize household participation. Other members of the household who do not have CKD 
or who are not enrolled in the study will also be allowed to participate in the sessions if 
they wish, and all subjects will be encouraged to keep their clinic appointments.  
Participant preference will be incorporated into the HBKC intervention arm by 
allowing participants to prioritize the order in which curriculum topic areas will be 

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emphasized by the CHRs. Topics from currently available NIDDK and IHS kidney 
education materials will include: (1) Kidney 101, (2) weight management, (3) exercise, (4) 
healthy eating, (5) medication management, (6) coping with stress, (7) risk factor 
management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) 
smoking cessation, and related health concerns. Given the interrelated nature of these 
topics, we will ensure that each of the curriculum areas will be covered in each household 
during the course of the 12 month intervention, but topics will be covered in differing order 
based upon participant preference and relevance to the participant’s current situation. 
Priority lists will be collected from subjects for later analysis as a covariate to determine if 
attention to “preference” facilitates the successful attainment of therapeutic goals. All 
sessions will include a brief coaching segment with a personalized review of progress 
made, problem-solving and goal-setting, as well as a safety assessment. CHRs will 
implement the intervention in the native language if preferred by the participants. Sessions 
will typically employ a problem solving approach with specific referral to community 
resources, as appropriate. We will also employ low-literacy tailored goal-setting and self-
monitoring worksheets.
In compliance with COVID-19 safety measures, the study has obtained approved by the funder 
and our community advisory board for adaptation to a telephone-based intervention model (i.e., 
delivering the educational sessions via telephone instead of in-person home visits) in 
communities where tribal leadership has imposed restrictions on home visiting.
Components: Aside from regularly scheduled home visits, participants in the HBKC group 
will be involved in activities actively promoted by the study investigators and incorporated 
into individualized treatment plans:
a. Text Reminders & Participant Text Responses: CHR generated text message reminders 
and participant text responses will be utilized to promote adherence to both medical and 
lifestyle interventions.  Participants in the HBKC group will receive weekly text messages 
from the CHR and be requested to send a text response within 24 hours. Response will be 
noted in a database. Text message content will be individualized and will offer adherence 
reminders in cultural- and language-appropriate formats.
b. Peer Support Groups: Participants will be offered peer support groups of 4-6 people. 
This type of “buddy system” has been shown to increase compliance in intervention studies 
and cross-sectional studies of exercise participation, and it enhances the sustainability of 
the intervention.
c. Group Didactic Sessions: Group sessions will be offered three times during the 
intervention of 12 months for 30 minutes and will be directed by the investigators, study 
coordinators and CHRs. The sessions may incorporate components of cognitive-behavioral 
therapy for weight loss, including self-monitoring of eating and exercise, behavioral goal 
setting, stimulus control techniques, cognitive restructuring, assertive communication 
skills, stress management, and relapse-prevention. Group discussions will focus on active 
problem solving and weight loss maintenance. Sessions will include culturally popular 
activities (e.g., traditional food, bingo games, eating together as a family, etc.) and will 
promote group cohesion, modeling of desirable behaviors, and peer support for change. 

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Group meals will include discussions around taste of the food prepared, the ease of food 
preparation, and strategies for implementing the recipes at home, acceptability to family 
and friends, and steps towards trying new eating styles at home. Participants will be 
provided with handouts for future reference.
In compliance with COVID-19 safety measures, the study has obtained approval from the funder 
and our community advisory board to conduct the group educational sessions via 
videoconference. Participants will also have the option to call in if videoconferencing 
technology is not available or internet connections are unstable.
COVID-19 related enhancement study – methods:
Study population: The study will include all HBKC participants screened.
a.
Inclusion Criteria 
Inclusion criteria:  Willingness to participate in the phone-based and or mail based 
survey.
Exclusion criteria: none
b.
 Risks/Benefits
This is a very low risk study.  However, there is always the risk of loss of confidentially. 
Some of the questions may cause some discomfort to the participants.
Participants will not directly benefit from participation in the study.  
Methods
1.
The attached instrument will be administered to all enrolled study participants by 
telephone and or mail. This will occur with an initial phone call to all participants in the 
near future. In addition, for tracking the impact of the COVID-19 epidemic on this study 
population we will return to the participants later to repeat completion of this survey. In 
some instances, the telephone contact to implement this survey will be bundled with a 
previously planned CRIC study visit. If it is not possible to do this at the time of a 
previously planned visit, the telephone contact to administer this survey will be an 
additional contact. It is estimated that this survey will take approximately 20 minutes to 
complete by telephone, a time, which has been found to be acceptable to HBKC Study 
participants, based on other telephone interactions conducted for the study. 
2.
Each of the sites will attempt to recruit all active HBKC participants at their site. 
3.
Study data will be collected and managed using RedCap data system currently in 
use.
10.
Data and Specimen Banking*
All data collected will be deposited into local tribal clinics and patient files kept at the 
tribal/IHS health facility. All patients will receive copy of their clinical data and 
anthropometric measurements. A REDCap folder will be created to enter all qualitative 
(demographics and anthropological measures) and quantitative data set.
We are not banking any biological material for this protocol.
11.
Data Management* and Confidentiality

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We plan to utilize the REDCap application for data management. REDCap (Research 
Electronic Data Capture) is a secure, web-based application designed exclusively to 
support data capture for research studies. REDCap provides: 1) an intuitive interface for 
data entry (with data validation); 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common 
statistical packages (SPSS, SAS, Stata, R); 4) procedures for importing data from external 
sources; and 5) advanced features, such as branching logic and calculated fields. We 
recognize the need for strict protection of confidentiality. Participants will be assigned a 
unique identifier (study ID number). The study ID number will be included on all research 
records for that study participant. Participants will have the option of having their study 
results of clinical meaning entered in their medical records. Participant tribal affiliation 
will also be assigned a unique identifier to ensure equal protection of individual and 
community identifiers.  All staff members will be trained to handle participants’ data with 
confidentiality. Staff will have controlled access to data. Each staff person will be assigned 
a user ID and a password. Access will be in layers, with appropriate fire walls in place. We 
will employ a web-based strategy with advanced security techniques. Data entry personnel 
will be certified. Server, CD, and secure hard copy storage will be available for each site. 
Information on study participation and study results for individual participants will not be 
released without the written consent of the participant. 
Precautions will be exercised in order to maintain the highest standard of anonymity. Each 
patient data/blood sample will be given a unique study number that will not be linked in 
any way to standard HIPAA-related personal  identifiers (including tribal affiliation), and 
importantly, the datasets we receive and will work with are Limited Data Sets in 
accordance with HIPAA guidelines (stripped of standard identifiers). All data undergo 
extensive QA/QC before being sent to us from each participating community. No reference 
to subject name or other personal identifiers that could jeopardize their privacy will appear 
in the database, or blood samples, in abstracts, scientific papers or other documents that 
emanate from this study. Importantly, random anonymous identifiers will be used to label 
blood samples.
We will inform participants of their Point of Care test results (UACR, serum creatinine and 
HbA1C) verbally and in writing at the time of testing. After the participant has given 
HIPPA consent, a copy of all testing and clinical measurements (height, weight waist 
circumference and blood pressure) will be given to medical records at the local tribal/IHS 
health facility to be placed in the patient’s medical record, to the attention of the patient’s 
primary provider.
12.
Provisions to Monitor the Data to Ensure the Safety of Subjects*
All CHRs will be provided with mobile tablets to display educational videos during home 
visits with participants and to administer the scales (Patient Activation Measure, 
Adherence, Kidney Disease QOL, Diet Questionnaire) at baseline, 6 months and 12 months 
as outlined in the table on p.10. All mobile tablets will be password protected.  The scales 
will be administered via REDCap, a secure, web-based application designed to support 

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data capture for research studies. No data will be stored on the tablet, rather all data is 
inputted directly into the online REDCap platform, which possesses secure web 
authentication, data logging, and Secure Sockets Layer (SSL) encryption. CHW field staff 
in each community will perform the initial data entry on recruitment and questionnaire 
information. The database in REDCap will have automated error checks, such as range 
checks, during data entry. Data error reports including checks for consistency, logic, and 
structural & relational integrity will be run monthly. These reports will consist of identified 
problems and include cross-tables for assessment and comparison of the data entries, with 
identification of errors. Records will be randomly sampled (10%) for completeness, 
consistency, and logic by the project coordinator and database manager. CHW Field staff 
will provide corrections based on the monthly reports and random samples of reviewed 
records. All de-identified clinical data received electronically in a password protected file 
from the labs once every month will be adjudicated with the hard copies.
The proposed research involves minimal risk only. However, we will continuously monitor 
the data. There are potential minor risks to the participant’s health if they take part in the 
study. Only trained and certified staff will perform venipuncture. Participants may get mild 
pain when we draw the blood. There is a small risk of bleeding, bruising (less than 10%) 
and infection (less than 1%) in the area where we put the needle. There is no risk from 
donating a urine sample.
Our protocol includes sharing all clinical and anthropological data electronically with the 
local providers /clinics (mainly run by I H S). Working along with those local providers 
we will make sure to have physician assigned to a participant if he/she is not in a system. 
Participant with the abnormal / critical values will be referred right away to local provider 
along with the assistance by our CHRs to bring the participant to the local clinic.
We will report the interim and completed project findings to all participants, their health 
care provider, the funding agency, IHS, IRBs, community advisory panels and tribal 
council. This reporting will be at least annually (i.e., progress report) with quarterly updates 
to the community advisory panel.
13.
Withdrawal of Subjects*
There are no criteria for study withdrawal other than a participant voluntarily requesting 
to withdraw.
14.
Risks to Subjects*
There are some small risks to participant’s health if they take part in the study.  Participants 
may have mild pain when we draw their blood. There is a small risk of bleeding, bruising 
(less than 10%) and infection (less than 1%) in the area where we put the needle. There is 
no risk when giving a urine sample.  We have established mechanism to protect the 
confidentiality of participant information. Nevertheless, accidental disclosure of study data 
may occur.  There are no alternative treatments appropriate for this protocol and no 
circumstances for terminating the study other than declining to participate in the study.

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15.
Potential Benefits to Subjects*
There may be no direct benefits to the participants. However, participants in this study may 
benefit individually from earlier diagnosis of Chronic Kidney Disease (CKD). Home based 
kidney care may result in better control of blood pressure, diabetes and cholesterol. 
Improving these items could slow down kidney disease. This study may also help future 
generations and other tribal communities by identifying new ways to manage diabetes and 
kidney disease. This study may help the participants to be able to make changes in their 
life-style by educational intervention and get medical care sooner.
16.
Vulnerable Populations*
Not Applicable
17.
Community-Based Participatory Research*
Valuable tribal input and engagement has already been secured in the conceptualization of 
this study.  The AASTEC Executive Council has established type II diabetes as its top 
health priority for the 2012-2017 period, and has charged AASTEC with the task of 
researching innovative, sustainable interventions to ameliorate existing disparities in this 
health priority area.  Likewise, sustainable partnerships have already been established 
between AASTEC, UNM HSC and the IHS Albuquerque Area Tribes through prior 
activities in the areas of health research, public health surveillance, community health 
assessment, program evaluation, and health promotion/disease prevention intervention. 
These partnerships will be leveraged and strengthened throughout this 3-year project.  
The first month of this project will focus on formalizing, strengthening and further 
developing existing relationships, as well as fostering trust between project partners and 
developing structures that will guide and support the project.  This practice is aligned with 
established tribal protocols for conducting health research in AI/AN communities.  Within 
each Tribe we will conduct meetings with clinicians, health administrators and CHR 
program directors to promote broad understanding of the study protocol and recruitment 
procedures.  Because this study is a new initiative, it will be necessary to fully outline the 
purpose and benefits of the research to the participating Tribes, the study protocol and key 
activities associated with participation, protocols for data sharing and maintaining 
confidentiality, and dissemination plans for project data and reports. The AASTEC PI (Dr. 
English) and project coordinator from AAIHB will travel to each intervention site on a 
routine basis during the first several months of the intervention period to strengthen rapport 
and finalize plans for the intervention.
The study team will also receive invaluable guidance from a community advisory panel 
which will include 2 stakeholders from each of the 4 participating tribes and meet on a 
quarterly basis (2 in person meetings and 2 virtual meetings).  This approach will ensure 
that our tribal partners are included in the research process from its inception and that 

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Revised: May 13, 20211
important cultural considerations are taken into account with study activities in each 
community.  
18.
Sharing of Results with Subjects*
We will prepare the clinical lab data and some of the anthropometric measures such as 
blood pressure and give a copy directly to the participant and offer to share them with their 
doctor. We will also, transfer a hard copy of the lab results into participant’s case file at 
the tribal/IHS health facility.
19.
Setting
The patient population for this study will include four of the 27 IHS Albuquerque Area 
Tribes.  We have already obtained verbal commitments from the 4 communities and will 
provide documentation of formal Tribal leadership approval to the IRB upon receipt. 
Each of these tribes currently operates a tribal/IHS health clinic/hospital, a CHR program, 
and a Special Diabetes for Indians Program (SDPI).  We will partner with each of these 
entities in each participating community to identify and recruit potential subjects and 
implement the intervention.  
In addition to the UNM Health Sciences Center IRB, IRB approval will be sought from 
the Southwest Tribal IRB to further ensure that the study team adheres to all tribal 
protocols for research.
20.
Resources Available
PI Dr Shah is a Molecular Epidemiologist with Health Services Research experience for 
more than 25 years. He has broad background in basic system biology science research and 
clinical translational and community based participatory studies in minorities including 
Native Americans and Hispanics. He has carried out the original cross sectional research 
in the Zuni Kidney Project with many secondary data analyses on disparity aspects of 
chronic diseases, in particular diabetes and CKD and its complications. He has served as a 
PI and or Co-PI on several NIDDK funded grants including: (1) Cytokine gene 
polymorphism in the CRIC Cohort Study; (2) Zuni Kidney Project; (3) Zuni component of 
FIND; (4) Genetics of Kidney Disease in Zuni Indians. Currently he is the PI on the 
UNMHSC component of the NIGMS funded NM INBRE grant and obtained an ARRA 
supplement to work with minority kids and young adults in educational intervention of life 
style, diet/nutrition and obesity in preventing chronic disease. In 2013 Dr Shah received a 
3yrs pilot funding from PCORI in developing effective measures of chronic diseases 
among Zuni Indians and delivering home based kidney care in randomized group of 
participants with CKD.

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The community–based PI of this proposed research, Kevin English, DrPH, directs the 
Albuquerque Area Southwest Tribal Epidemiology Center, which was established in 2006 
and is the only tribal research entity that serves all of the 27 Albuquerque Area Tribes. 
AASTEC is one of twelve Tribal Epidemiology Centers across the country, and is 
committed to serving the AI/AN population in the Southwest in several core areas, 
including:  health research, tribal community health assessment, public health surveillance, 
and capacity development. AASTEC is housed within the Albuquerque Area Indian Health 
Board, Inc. (AAIHB), an intertribal, non-profit organization established in 1977.  For the 
past three decades, AAIHB has been a leader in the provision of culturally appropriate 
health services research (including cancer control research), health promotion/disease 
prevention intervention, technical assistance/capacity building and specialized clinical 
services including audiology and HIV/AIDS prevention education.  The AAIHB also 
operates the Tribal Institutional Review Board (IRB) for all research that occurs among the 
27 Albuquerque Area Tribes.  The AAIHB offices are located in Albuquerque, which is 
centrally located among the Tribes it serves and affords access to numerous resources and 
partners such as the Indian Health Service (IHS) Albuquerque Area Office, the University 
of New Mexico Health Science Center (UNM HSC), and the State of New Mexico 
Department of Health.  In addition to the aforementioned community advisory panels, the 
well-established AASTEC Executive Council, which includes tribal representatives from 
all 27 Albuquerque Area Tribes and two intertribal organizations – AAIHB and the All 
Indian Pueblo Council (AIPC) – will also provide tribal-specific oversight and guidance 
throughout all facets of this proposed research.  Dr. English also possess vast experience 
in CHR intervention research, including the design, implementation and evaluation of 
health promotion/disease prevention intervention research with American Indian Tribes in 
the Southwest for over a decade. Dr English earned my Doctor of Public Health Degree 
from Columbia University in February 2013 and was awarded the Marisa De Castro Benton 
Award for distinguished scholarship and research, and outstanding contribution to the 
Sociomedical Sciences, worthy of special recognition in a doctoral dissertation entitled " 
An Exploration of Determinants that Impact Tribal Community Health Worker (CHW) 
Capacity to Engage in Breast and Cervical Cancer Health Education, Outreach and Patient 
Navigation Services”. In his present position as the Director of the Albuquerque Area 
Southwest Tribal Epidemiology Center (AASTEC), he leads the design and 
implementation of a national demonstration program aimed to build the capacity of tribal 
community health workers to engage in health education, outreach and patient navigation 
to promote cancer screening in American Indian communities. Dr English’s leadership at 
AASTEC has also entailed the establishment of collaborative partnerships between 
AASTEC, 27 Southwest Tribes and researchers at the UNM Health Science Center. He 
possess high standing within each of these environments. Working directly for American 
Indians within the context of an intertribal organization has allowed him to establish 
significant rapport and trust with this population where the discovery of culturally 
appropriate, innovative and sustainable interventions to address persistent health disparities 
is sorely needed.
21.
Prior Approvals
Not Applicable

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22.
Recruitment Methods
We will use a combination of clinic and community-based approaches to inform Tribal 
members of the study.   We will utilize the IHS Diabetes Audit to identify patients who are 
likely to meet the study eligibility criteria (i.e., age 21 to 80 years; and diagnosed diabetics 
or HbA1c >7, UACR > 30 and BMI >27 kg/m2.).  These individual will receive a mailing 
with information about the study and a culturally appropriate brochure that highlights the 
relationship between diabetes and chronic kidney disease.  Two follow-up letters will be 
mailed in 3 week increments and the CHR will also make home visits to non-responsive 
individuals.  Clinic providers will also be encouraged to provide information about the 
study to potentially eligible tribal members who present at the clinic during the study period 
until full enrollment is achieved.  Community-based approaches to inform other Tribal 
members about the study will include community meetings, posters, health fairs, and 
notices in the tribal newspapers/newsletters.  As previously detailed, this study will employ 
a full-time CHR in each of the four participating Tribes, who will also serve as community-
based messengers about the study and will be available to answer specific questions that 
emerge from tribal members in real time.  
Study recruitment will proceed as follows within each selected Tribe. We will screen up to 
150 potential enrollees for participation from each Tribe (n=4) and gather baseline data.  
We will screen participants for the study by measuring BP, height, weight, HgA1C, urinary 
albumin to creatinine ratio, and serum creatinine. For patients who are eligible by 
screening, we will randomize them to either receive the intervention immediately or to 
receive it on a delayed timeline in a 1:1 ratio. We will continue enrollment and 
randomization until we have randomized 30 individuals into each treatment arm within 
each Tribe. The individuals in the immediate intervention group will participate in the 
intervention program while those in the delayed intervention group will continue with their 
typical care in year 1.  After the first 12 months, participants in the delayed intervention 
arm will be invited to continue in the study and will receive the same intervention as was 
supplied to participants randomized to the immediate intervention arm.
All participants participated in the screening will receive a $25 merchandise card and those 
that agree to participate in the study will receive payments of $50 at baseline, and $25 at 3 
months, 6 months, 9 months 12 months and 16 months of the intervention.
  
23.
Local Number of Subjects
The table below describes the total subjects screened and CKD cohort identified with the 
intervention at each site.
Estimated number of potentially eligible study 
participants (describe how this number was 
determined [e.g., EHR, claims data, clinic logs, 
administrative data, other]):
Each Tribe’s population 
averages 2,000 members 
and as per IHS database, 
>150 participants with 

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T2DM will be eligible 
for the study.
Total number of study participants expected to be 
screened:
600 (150 in each Tribe)
Total number of study participants expected to be 
eligible of those screened:
306
Target sample size (use same number stated in 
milestones):
240 (60 per community)
If applicable, total number of practices/centers that 
will enroll participants:
4
Projected month first participant enrolled (month 
after project initiation):
3
Projected month last participant enrolled (month 
after project initiation):
20
Projected rate of enrollment (anticipated number 
enrolled per month of enrollment period):
75/month for screening. 
30/month for the 
intervention
24.
Confidentiality
We recognize the need for strict protection of confidentiality. Participants will be assigned 
a unique identifier (study ID number). The study ID number will be included on all research 
records for that study participant. Participant tribal affiliation will also be assigned a unique 
identifier to ensure equal protection of individual and community identifiers.  Participants 
will have the option of having their clinically relevant study results entered in their medical 
records. All staff will be trained to handle participants’ data with confidentiality. Staff will 
have controlled access to data. Each staff person will be assigned a user ID and a password. 
Access will be in layers, with appropriate firewalls in place. We will employ a web-based 
strategy with advanced security techniques. Data entry personnel will be certified. Server, 
CD, and secure hard copy storage will be available at each site. Information on study 
participation and study results for individual participants will not be released without the 
written consent of the participant.
Precautions will be exercised to maintain the highest standard of anonymity. Each patient 
data/blood sample will be given a unique study number that will not be linked in any way 
to standard HIPAA-related personal identifiers, and importantly, the datasets we receive 
and will work with are Limited Data Sets in accordance with HIPAA guidelines (stripped 
of standard identifiers). All data undergo extensive QA/QC before being sent to us. The 
primary database will have some personal identifier in order to link the participant with 
their data. However, no reference to subject name or other personal identifiers that could 
jeopardize their privacy will appear in the abstracts, scientific papers or other documents 
that emanate from this study.
25.
Provisions to Protect the Privacy Interests of Subjects

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Participation in research will involve a loss of privacy, but information about subjects will 
be handled as confidentially as possible. Representatives of the University of New Mexico 
Health Sciences Center Human Research Review Committee that oversees human subject 
research, t or other regulatory agencies such as Indian health Services will be permitted 
access to subjects’ records. Also, subject’s participation in the study and information in 
their study records may be disclosed to their doctors, and may be disclosed as otherwise 
provided by law.  However, subjects name will not be used in any published reports about 
this study. Hard copy of all study results will be kept in locked cabinets. Electronic copies 
of study results will be kept in pass word protected files in computers located in offices of 
study personnel.  Only authorized study personnel, representatives of the Southwest Tribal 
and the Human Research Review Committees of the UNMHSC and participating Tribes 
and community advisory panels will have access to study results. Study related results and 
their reporting and publications will be presented to the tribal leadership before 
dissemination.
26.
Compensation for Research-Related Injury
Not Applicable - Minimal risk only
 
27.
Economic Burden to Subjects
Not Applicable – NONE
28.
Consent Process
We will conduct screening evaluation which includes (1) personal interview; (2) physical 
exam; (3) anthropometric measurements (5) serum chemistries; (6) biomarkers. The 
consent form will be administered to all participants in English, however local CHRs may 
use the tribal language to describe the content of the consent document. We will not create 
separate consent form in the tribal language. The consent process will be:
Introduction of field representatives (CHRs) takes 5 minutes.
10 minutes - summary of the project.
3 minutes to explain HIPPA.
15 minutes to explain Consent Form.
35 minutes for completing the Questionnaire.
5 minutes to take client's Vitals.
5 minutes for Blood Draw.
3 minutes for Urine sample.
29.
Process to Document Consent in Writing
Not Applicable
30.
Drugs or Devices
Not Applicable