A culturally informed model to enhance breast, cervical, and colorectal cancer screenings: perspectives of American Indian adults and healthcare providers in rural New Mexico.

PURPOSE: American Indian/Alaska Native (AI/AN) populations have some of the lowest cancer screening rates compared to other racial/ethnic populations. Using community-based participatory research methods, we sought to characterize knowledge, attitudes, beliefs, and approaches to enhance breast, colorectal, and cervical cancer screening. METHODS: We conducted 12 focus groups between October 2018 and September 2019 with 96 eligible AI adults and healthcare providers, recruited using non-probability purposive sampling methods from the Zuni Pueblo in rural New Mexico. We used the Multi-level Health Outcomes Framework (MHOF) to conduct a qualitative content analysis identifying mutable systems- and individual- level constructs important for behavior change that we crosslinked with the Community Preventive Services Task Force (CPSTF) recommended evidence-based interventions (EBIs) or approaches. RESULTS: Salient systems-level factors that limited uptake of cancer screenings included inflexible clinic hours, transportation barriers, no on-demand service and reminder systems, and brief doctor-patient encounters. Individual-level barriers included variable cancer-specific knowledge that translated into fatalistic beliefs, fear, and denial. Interventions to enhance community demand and access for screening should include one-on-one and group education, small media, mailed screening tests, and home visitations by public health nurses. Interventions to enhance provider delivery of screening services should include translation and case management services. CONCLUSIONS: The MHOF constructs crosslinked with CPSTF recommended EBIs or approaches provided a unique perspective to frame barriers and promoters of screening utilization and insights for intervention development. Findings inform the development of culturally tailored, theoretically informed, multi-component interventions concordant with CPSTF recommended EBIs or approaches aimed at improving cancer screening.

Propofol dose and efficacy of defibrillation testing during implantation of subcutaneous implantable cardioverter-defibrillators: A retrospective, single center cohort study.

INTRODUCTION: Defibrillation testing (DFT) is recommended during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Previous studies analyzing the potential interference of propofol with defibrillation threshold are inconsistent. The purpose of this study was to analyze whether propofol affects DFT post S-ICD placement. METHODS: All patients with S-ICD implantation between 01/2017 and 11/2020 at the University Heart Center Freiburg were retrospectively analyzed. Two groups were generated depending on the success of the first shock during DFT. Implantation characteristics and dose of anesthetics were analyzed. RESULTS: In 12 of the included 80 (15%) patients, first shock during DFT failed. The absolute dose of propofol was significantly higher in patients with first shock failure (median 653 mg [IQR 503-855]) compared to patients with first shock termination (376 mg [200-600]; p = 0.027). Doses of opioids and midazolam as well as type of anesthesia did not differ between the groups. A multivariable binary logistic regression analysis confirmed an independent association of first shock termination and propofol dose (per 100 mg: OR 0.73 (95% CI: 0.56-0.95); p = 0.021). CONCLUSION: There is an independent association of propofol dose and first shock failure in routine S-ICD defibrillation testing.

Albuminuria, cognition, and MRI biomarkers of cerebrovascular disease in American Indians of the Zuni Pueblo.

Background: Elevated urine albumin to creatinine ratio (UACR) is associated with cerebrovascular disease and cognitive impairment in older adults, though few studies have evaluated these relationships in midlife. This is particularly important to assess in American Indian populations, which are disproportionately impacted by diabetes and kidney disease. Additionally, evidence suggests that biomarkers may perform differently in underrepresented groups, thus, it is crucial to validate biomarkers in this unique population. Methods: Twenty-five participants from the Zuni Pueblo underwent neuropsychological assessment and an MRI that included fluid attenuated inversion recovery (FLAIR) and diffusion imaging to calculate recently developed MRI markers of cerebrovascular small vessel disease (Peak width of Skeletonized Mean Diffusivity (PSMD), mean free-water fraction (mFW), white matter hyperintensity (WMH)). Results: Regression analyses indicated no significant associations between UACR, MRI biomarkers and cognitive outcomes. Analyses of covariance indicated that the Zuni Indian cohort exhibited reduced white matter damage relative to an existing cohort of older adults with vascular cognitive impairment when accounting for age, sex, and education. Slower processing speed was associated with greater white matter disease across all measures examined. Conclusions: Our pilot study validated the use of MRI biomarkers of cerebrovascular disease in this unique cohort of American Indians.

Initial Clinical Experience With a Novel 8-Spline High-Resolution Mapping Catheter.

BACKGROUND: The Octaray (Biosense Webster) is a novel, multispline mapping catheter with 48 closely spaced microelectrodes enabling high-resolution electroanatomical mapping. OBJECTIVES: This study sought to report the initial clinical mapping experience with this novel catheter in a variety of cardiac arrhythmias and to compare the mapping performance with the 5-spline Pentaray. METHODS: Fifty consecutive procedures among 46 patients were retrospectively analyzed regarding safety, efficacy, and acute procedural success defined as termination or noninducibility of clinical tachycardia, conduction block across an ablation line, or pulmonary vein isolation. In addition, another 10 patients with sustained atrial tachycardia mapped with the 5-spline catheter (2-5-2 spacing) or the novel 8-spline catheter (2-2-2-2-2 spacing) were analyzed. RESULTS: Left atrial and ventricular mapping by either transseptal (n = 41) or retroaortic (n = 2) access was feasible without any complications related to the multispline design of the novel catheter. The acute procedural success rate was 94%. In sustained atrial tachycardia compared with the 5-spline catheter, the novel 8-spline catheter recorded more electrograms per map (3,628 ± 714 vs 11,350 ± 1,203; P < 0.001) in a shorter mapping time (13 ± 2 vs 9 ± 1 minutes; P = 0.08) resulting in a higher point density (18 ± 4 vs 59 ± 10 electrograms/cm2; P < 0.01) and point acquisition rate (308 ± 69 vs 1,332 ± 208 electrograms/min.; P < 0.01). CONCLUSIONS: In this initial experience, mapping with the novel catheter was safe and efficient with a high electroanatomical resolution. In sustained atrial tachycardia the novel 8-spline catheter demonstrated a marked increase in point density and mapping speed compared with those of the 5-spline catheter. These initial results should be validated in a larger multicenter cohort with longer follow-up.

Catheter ablation of short-coupled variant of torsade de pointes.

BACKGROUND: The short-coupled variant of torsade de pointes (sc-TdP) is a malignant arrhythmia that frequently presents with ventricular fibrillation (VF) electrical storm. Verapamil is considered the first-line therapy of sc-TdP while catheter ablation is not widely adopted. The aim of this study was to determine the origin of sc-TdP and to assess the outcome of catheter ablation using 3D-mapping. METHODS AND RESULTS: We retrospectively analyzed five patients with sc-TdP who underwent 3D-mapping and ablation of sc-TdP at five different institutions. Four patients initially presented with sudden cardiac arrest, one patient experienced recurrent syncope as the first manifestation. All patients demonstrated a monomorphic premature ventricular contraction (PVC) with late transition left bundle branch block pattern, superior axis, and a coupling interval of less than 300 ms. triggering recurrent TdP and VF. In four patients, the culprit PVC was mapped to the free wall insertion of the moderator band (MB) with a preceding Purkinje potential in two patients. Catheter ablation using 3D-mapping and intracardiac echocardiography eliminated sc-TdP in all patients, with no recurrence at mean 2.7 years (range 6 months to 8 years) of follow-up. CONCLUSION: 3D-mapping and intracardiac echocardiography demonstrate that sc-TdP predominantly originates from the MB free wall insertion and its Purkinje network. Catheter ablation of the culprit PVC at the MB free wall junction leads to excellent short- and long-term results and should be considered as first-line therapy in recurrent sc-TdP or electrical storm.

Assessing Knowledge and Perceptions About Cancer Among American Indians of the Zuni Pueblo, NM.

American Indians (AIs) in New Mexico have lower cancer screening rates compared to other populations and are more likely to be diagnosed with cancer at an advanced stage of the disease as reported by Li et al. (Archives of Internal Medicine 163(1):49-56, 2003). AIs also have the lowest 5-year cancer survival rates compared to any ethnic/racial group in the USA as reported by Clegg et al. (Arch Intern Med 162:1985-1993, 2002) and Edwards et al. (Cancer 97:1407-1427, 2005). Numerous barriers such as cultural beliefs, fear, fatalism, mistrust, stigma, and lack of culturally appropriate interventions could contribute to low cancer screening rates as reported by Daley et al. (J Health Dispar Res Pract 5(2), 2012); Filippi et al. (J Prim Care Community Health 4(3):160-166, 2013); James et al. (Prev Chronic Dis 10:E170, 2013); and Schumacher et al. (Cancer Causes Control 19(7):725-737, 2008). Trained Community Health Representatives (CHRs) from the Zuni Pueblo and native Zuni undergraduate students led six 1-h focus group sessions using a structured focus group guide with probes. The focus groups were conducted among 51 participants from different age groups (20-29 years, n = 19; 30-49 years, n = 17; and 50 years and older, n = 15) stratified by sex. Focus groups were conducted in both English and Shiwi (Zuni) languages. Sessions were audio recorded, and team members took notes. CHRs transcribed the notes and audio recordings, and created a codebook for qualitative data analysis. In the focus groups, participants provided Zuni-specific cultural context, opinion, and experience regarding (1) general knowledge about cancer, (2) cancer risk, (3) cancer risk reduction, (4) personal experiences with cancer, and (5) culturally competent delivery of cancer information and resources. Understanding the perceptions of cancer within the Zuni Pueblo is an essential component in the development of interventional/preventative measures and improvement of current care. Ultimately, this information will provide a basis for the next steps in culturally sensitive cancer care for the Zuni Pueblo.

Device interaction between cardiac contractility modulation (CCM) and subcutaneous defibrillator (S-ICD).

Combined implantation of cardiac contractility modulation (CCM) with subcutaneous implantable cardioverter-defibrillator (S-ICD) appears a suitable option to reduce the amount of intracardiac leads and complications for patients. Here we report on a patient with ischemic cardiomyopathy carrying an S-ICD in which a CCM device was implanted. During crosstalk testing post-CCM implantation, the S-ICD misannotated QRS complexes and T waves. The problem was solved through reprogramming the CCM, while preserving S-ICD functionality and improving heart failure symptoms. In conclusion, S-ICD combined with CCM seems to be a good and safe option for patients when device interference is being ruled out.

Diabetes status modifies the efficacy of home-based kidney care for Zuni Indians in a randomized controlled trial.

BACKGROUND: Home-Based Kidney Care (HBKC) is a pragmatic treatment approach that addresses patient preferences and cultural barriers to healthcare. We previously reported the results of a clinical trial of HBKC vs. usual care in a cohort of Zuni Indians in New Mexico. This study investigated the potential for differential efficacy of HBKC vs. usual care according to type 2 diabetes (T2DM) status. METHODS: We analyzed the data from all individuals who participated in a randomized clinical trial that compared HBKC to usual care among patients with CKD, and assessed whether the effect of the HBKC intervention affected the subset of patients with T2DM differently than those individuals without T2DM. We used linear regression models to estimate the effect of HBKC on improvement in Patient Activation Measure (PAM) total scores within the groups of participants defined by T2DM status, and to compare the effects between these two groups. We used generalized estimating equations (GEE) to account for household clustering. RESULTS: The original study enrolled 63 participants into the HBKC group, and 62 into the usual care. Ninety-eight of these individuals completed the 12-month intervention, 50 in the HBKC group and 48 in the usual care group. The present study compared the intervention effect in the 56 participants with T2DM (24 participants in the HBKC group and 32 in usual care) to the intervention effect in the 42 participants without T2DM (26 participants in the HBKC group and 16 in usual care). Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group. For those without T2DM, the intervention had essentially no effect, with those who received the HBKC intervention having an average PAM total scores that was 1.4 points (95% C.I.: -12.4 to 9.6) lower than those who received usual care. There was a significantly different HBKC treatment effect by T2DM status (p = 0.02). CONCLUSION: This secondary analysis suggests that the effectiveness of this HBKC intervention on increasing patient activation is most notable among those CKD patients who also have T2DM.

Two siblings with early repolarization syndrome: clinical and genetic characterization by whole-exome sequencing.

AIMS: The early repolarization syndrome (ERS) can cause ventricular fibrillation (VF) and sudden death in young, otherwise healthy individuals. There are limited data suggesting that ERS might be heritable. The aim of this study was to characterize the clinical phenotype and to identify a causal variant in an affected family using an exome-sequencing approach. METHODS AND RESULTS: Early repolarization syndrome was diagnosed according to the recently proposed Shanghai ERS Score. After sequencing of known ERS candidate genes, whole-exome sequencing (WES) was performed. The index patient (23 years, female) showed a dynamic inferolateral early repolarization (ER) pattern and electrical storm with intractable VF. Isoproterenol enabled successful termination of electrical storm with no recurrence on hydroquinidine therapy during 33 months of follow-up. The index patient's brother (25 years) had a persistent inferior ER pattern with malignant features and a history of syncope. Both parents were asymptomatic and showed no ER pattern. While there was no pathogenic variant in candidate genes, WES detected a novel missense variant affecting a highly conserved residue (p. H2245R) in the ANK3 gene encoding Ankyrin-G in the two siblings and the father. CONCLUSION: We identified two siblings with a malignant ERS phenotype sharing a novel ANK3 variant. A potentially pathogenic role of the novel ANK3 variant is suggested by the direct interaction of Ankyrin-G with the cardiac sodium channel, however, more patients with ANK3 variants and ERS would be required to establish ANK3 as novel ERS susceptibility gene. Our study provides additional evidence that ERS might be a heritable condition.

Impact of Preprocedural Aortic Valve Calcification on Conduction Disturbances after Transfemoral Aortic Valve Replacement.

AIM: The present study analyzes in depth the impact of different calcification patterns on disturbances of the conduction system in transcatheter aortic valve replacement (TAVR) patients. METHODS AND RESULTS: A total of 169 preprocedural TAVR multislice computed tomography scans from consecutive transfemoral (TF) TAVRs performed between 2014 and 2017 using either Edwards SAPIEN or Medtronic Evolut R valves were retrospectively evaluated. The volume, distribution, and orientation of annular and valvular aortic valve calcification were measured and their impact on postoperative conduction disturbances was determined using linear and logistic regression analyses. The total volume of calcification and distribution at the aortic annulus or valve did not influence the conduction system. Oval calcification of the left aortic cusp was independently associated with an elevated risk for an increase in atrioventricular block degree (+0.6, p = 0.03). Moreover, orthogonal calcifications at the level of the aortic annulus were associated with an increased risk for QRS prolongation (+26 ms, p = 0.004) and an increased risk for permanent pacemaker implantation (OR 4.3, p = 0.03) after TF TAVR. This was more pronounced in patients undergoing TF TAVR using a balloon-expandable Edwards SAPIEN 3 valve (QRS +38.195 ms, p < 0.001; OR permanent pacemaker 15.48, p = 0.013). CONCLUSION: Orthogonal annular calcification confers an increased risk for conduction disturbances after TAVR. This is even more pronounced after implantation of balloon-expandable valves.

Mahaim pathway potential revealed by high-resolution three-dimensional mapping.

Mapping and ablation of atriofascicular fibers can be highly challenging due to the complex and dynamic anatomy of the tricuspid valve annulus. This case highlights the utility of a multi-electrode catheter three-dimensional mapping approach to localize the Mahaim pathway along the tricuspid annulus in order to guide catheter ablation.

American Indian chronic Renal insufficiency cohort study (AI-CRIC study).

BACKGROUND: Chronic kidney disease (CKD) is an increasing epidemic globally that is associated with adverse health outcomes including end stage kidney disease (ESKD), cardiovascular disease (CVD), and death. American Indians (AIs) have a higher prevalence of CKD than most other racial/ethnic groups, due in part to a high prevalence of type 2 diabetes. Other genetic and environmental factors not yet identified may also contribute to the disproportionate burden of CKD in AIs. METHOD: We will establish 3 clinical centers to recruit AIs from the Southwest United States (US) to expand the Chronic Renal Insufficiency Cohort (CRIC) study. We will follow the current CRIC protocol for kidney and cardiovascular measures and outcomes, which include ambulatory monitoring of kidney function and the use of mobile health technologies for CVD sub-phenotyping, and compare the outcomes in AIs with those in other racial/ethnic groups in CRIC. DISCUSSION: AI-CRIC will identify the role of various risk factors for rapid loss of kidney function among AIs of the Southwest US. In addition, to better understand the natural history of CKD and CVD in this high-risk population, we will identify unique risk factors for CKD and CVD progression in AIs. We will also compare event rates and risk factors for kidney and cardiovascular events in AIs with the other populations represented in CRIC.

Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial.

BACKGROUND AND OBJECTIVES: The burden of CKD is greater in ethnic and racial minorities and persons living in rural communities, where access to care is limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A 12-month clinical trial was performed in 98 rural adult Zuni Indians with CKD to examine the efficacy of a home-based kidney care program. Participants were randomized by household to receive usual care or home-based care. After initial lifestyle coaching, the intervention group received frequent additional reinforcement by community health representatives about adherence to medicines, diet and exercise, self-monitoring, and coping strategies for living with stress. The primary outcome was change in patient activation score, which assesses a participant's knowledge, skill, and confidence in managing his/her own health and health care. RESULTS: Of 125 randomized individuals (63 intervention and 62 usual care), 98 (78%; 50 intervention and 48 usual care) completed the 12-month study. The average patient activation score after 12 months was 8.7 (95% confidence interval, 1.9 to 15.5) points higher in the intervention group than in the usual care group after adjusting for baseline score using linear models with generalized estimating equations. Participants randomized to the intervention had 4.8 (95% confidence interval, 1.4 to 16.7) times the odds of having a final activation level of at least three ("taking action") than those in the usual care group. Body mass index declined by 1.1 kg/m2 (P=0.01), hemoglobin A1c declined by 0.7% (P=0.01), high-sensitivity C-reactive protein declined by 3.3-fold (P<0.001), and the Short-Form 12 Health Survey mental score increased by five points (P=0.002) in the intervention group relative to usual care. CONCLUSIONS: A home-based intervention improves participants' activation in their own health and health care, and it may reduce risk factors for CKD in a rural disadvantaged population.

Fascicular parasystole and recurrent syncope - a case report.

INTRODUCTION: Parasystole refers to an ectopic pacemaker that discharges with a constant rate competing with the primary pacemaker of the heart the sinus node. Parasystolic pacemakers have been described in the atrium, atrioventricular node, His bundle, and in the ventricle. Ventricular parasystole usually carries a benign prognosis, but there are a few reports of ventricular tachyarrhythmia initiated by parasystolic beats. CASE PRESENTATION: We present a case of a 15-year-old otherwise healthy teenager with recurrent most likely arrhythmic syncope who was diagnosed with ventricular parasystole from the left posterior fascicle. After exclusion of structural and primary electrical heart disease, the patient was deemed at increased risk of parasystole-induced tachyarrhythmia, and thus catheter ablation of the ectopic focus was performed. Since catheter ablation the patient continues to be free of any symptoms. DISCUSSION: This report highlights the potential risks of parasystole in context of recurrent syncope and reviews the available literature on parasystole and ventricular tachyarrhythmia.

Managing CKD by Telemedicine: The Zuni Telenephrology Clinic.

Telemedicine has significant potential to extend nephrology consultation to rural and isolated communities. We describe a telenephrology clinic that has delivered ongoing consultative care from a nephrologist based at the National Institutes of Health in Bethesda, MD, to the Zuni Comprehensive Health Center in western New Mexico. Over the past 9 years, the clinic has conducted 1870 patient visits managing patients using a collaborative approach engaging a nurse case manager, nephrologist, primary clinicians, pharmacists, and community health nurses. A significant proportion of the care provided is directed toward patients with advanced kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2). Although there are unique aspects to the Indian Health Service and to the Zuni community which is served by this clinic, this telemedicine clinic does serve as a demonstration that nephrologic consultative care can be delivered effectively and efficiently to rural high-risk communities using a collaborative and integrated model of care.

Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases.

Including target populations in the design and implementation of research trials has been one response to the growing health disparities endemic to our health care system, as well as an aid to study generalizability. One type of community-based participatory research is "Patient Centered-Research", in which patient perspectives on the germane research questions and methodologies are incorporated into the study. The Patient-Centered Outcomes Research Institute (PCORI) has mandated that meaningful patient and stakeholder engagement be incorporated into all applications. As of March 2015, PCORI funded seven clinically-focused studies of patients with kidney disease. The goal of this paper is to synthesize the experiences of these studies to gain an understanding of how meaningful patient and stakeholder engagement can occur in clinical research of kidney diseases, and what the key barriers are to its implementation. Our collective experience suggests that successful implementation of a patient- and stakeholder-engaged research paradigm involves: (1) defining the roles and process for the incorporation of input; (2) identifying the particular patients and other stakeholders; (3) engaging patients and other stakeholders so they appreciate the value of their own participation and have personal investment in the research process; and (4) overcoming barriers and challenges that arise and threaten the productivity of the collaboration. It is our hope that the experiences of these studies will further interest and capacity for incorporating patient and stakeholder perspectives in research of kidney diseases.

Exercise Intervention Improves the Metabolic Profile and Body Composition of Southwestern American Indian Adolescents.

INTRODUCTION/PURPOSE: The Southwestern American Indian population carries a high prevalence of metabolic syndrome and obesity, placing this group at higher risk than the general population for developing early type 2 diabetes and cardiovascular disease, likely impacting overall lifespan. This study aims to evaluate the impact of early lifestyle interventions which promote healthy eating and regular exercise on risk factors contributing to the development of the metabolic syndrome among the adolescent Zuni Pueblo population. MATERIALS AND METHODS: We describe a prospective, single site, community-based cohort study performed among sixty-five adolescent Zuni Indians aged 13.9 ± 1.7 years who were recruited between March 2011 and January 2014. The study intervention consisted of a targeted, tri-weekly exercise regimen with nutritional counselling, and the primary study outcomes included changes from baseline in metabolic profile (fasting lipids, A1c), vital signs (blood pressure, resting heart rate) and anthropometric characteristics of the study group. RESULTS: 41 participants have anthropometric data measured at baseline and after completion, biochemical data are available from 30 participants, and body composition data from 26 patients. Using the paired Student's t-test with Bonferroni correction, significant improvements were shown in pediatric BMI percentile, fasting lipid profile, A1C, total body fat, and fat free mass after six months of exercise and nutritional intervention. CONCLUSIONS: A simple, standardized fitness program among Southwest American Indian adolescents was effective at reducing fasting lipids and adiposity, as well as improving glycemic indices over the course of six months.

A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians.

INTRODUCTION: One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations despite a plethora of new therapies. Patient empowerment is a key determinant of diabetes control, but such empowerment can be difficult to achieve due to resource limitation and cultural, language and health literacy barriers. We describe a home-based educational intervention using Community Health Representatives (CHRs), leading to improvement in Patient Activation Measures scores and clinical indicators of diabetes control. METHODS: Sixty participants with type 2 diabetes (T2D) completed a baseline evaluation including physical exam, Point of Care (POC) testing, and the Patient Activation Measure (PAM) survey. Participants then underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated. RESULTS: PAM scores were increased by at least one level in 35 (58%) participants, while 24 participants who started at higher baseline score did not change. Six months after intervention, mean levels of A1C decreased by 0.7 ± 1.2%; fasting blood glucose decreased by 24.0 ± 38.0 mg/dl; BMI decreased by 1.5 ± 2.1 kg/m2; total cholesterol decreased by 12.0 ± 28.0 mg/dl; and triglycerides decreased by 52.0 ± 71.0 mg/dl. All of these changes were statistically significant (p < 0.05). CONCLUSION: This six month, CHR led and community-oriented educational intervention helps inform standards of practice for the management of diabetes, engages diabetic populations in their own care, and reduces health disparities for the underserved population of Zuni Indians. TRIAL REGISTRATION: ClinicalTrials.gov NCT02339311.