Clinical trial NCT02915029: Home-base Kidney Care in Zuni Indians
Official title: Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Native American
Community Health Representative
Home base
Diabetes
Point of care testing
Patient Activation Measure
Patient preferences
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Zuni Tribal Administration
name: Zuni comprehensive Community Health Center, Indian Health Services
First posted: 2016-09-26
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD). CKD is associated with increased risks for heart disease and death. The burden of chronic kidney disease is increased among minority populations compare to Caucasians. The Zuni Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to assess the safety and efficacy of conducting a full-scale study to determine if home based care delivered by a collaborative team composed of community health workers and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.

Detailed description: Hypothesis: (1) The Zuni Health Initiative (ZHI) can integrate an innovative approach to Home based kidney care (HBKC) utilizing tribal Community Health Representatives (CHRs), Point of Care (POC) technology, telemedicine and motivational messaging in conjunction with patient preferences and Patient Activation Measures (PAM) into the chronic care model to improve the detection and treatment of Chronic Kidney Disease (CKD) and related risk factors; (2) This model is generalizable to other high-risk communities e.g., Hispanic and American Indians in Guadalupe, AZ being studied by NIDDK, NIH-Phoenix.

Specific Aim 1: Re-phenotype prior participants, to identify incident cases of CKD, estimate progression rates, and identify participants for the proposed study of HBKC;

Specific Aim 2: Conduct a pilot study of HBKC in 120 people. Randomize households in a 1:1 allocation to usual care versus HBKC. Compare the changes in Patient Activation measure (PAM), Adherence, BP, weight, HbA1c, UACR, eGFR and lipid profiles between the two groups over the 1-year intervention period;

Specific Aim 3: Inform the design of the full-scale study by estimating anticipated recruitment, adherence and dropout rates, sample size and reassessing the approach;

Specific Aim 4: Assess the exportability of the HBKC model to Hispanics and American Indians in Guadalupe, AZ.

Study Outcomes: (1) The PAM and adherence; (2) Changes in clinical phenotypes including Cr, UACR, A1c, body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids, and inflammatory markers; (3) Changes in the quantitative traits such as diet and scores from a battery of mental-health, self-efficacy, and quality of life instruments.

Health Impact: The active participation of the Zuni tribal leadership and IHS in this protocol, and the general affordability of Zuni native CHR personnel, render the outcomes that will be demonstrated by this proposal easily sustainable over the long term. If successful, this program has the potential to change best-practices for CKD progression and to reduce health disparities in a cost-effective and sustainable manner.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of diabetes
* Clinical diagnosis of microalbuminuria
* Must be living in a household with more than 1 living participant
* Age 21 to 80 years
* Must have negative pregnancy test in women of child-bearing potential

Exclusion Criteria:

* Life expectancy \< 1 year
* On dialysis
* With renal transplant
* Pregnancy or absence of reliable birth control in women of child-bearing potential
* Malignancy except non-melanoma skin cancer
* Blind
* Unwilling or unable to give informed consent.

Primary outcomes:
measure: Patient Activation Measure (PAM) -13 Item Questionnaire
timeFrame: 12 months follow-up minus baseline values
measure: Patient Activation Measure (PAM) Level Greater Than 2
timeFrame: 12 months follow-up
Secondary outcomes:
measure: A1c
timeFrame: 12 months minus baseline values
measure: Diastolic Blood Pressure
timeFrame: 12 months minus baseline values
measure: Systolic Blood Pressure
timeFrame: 12 months minus baseline values
measure: Body Mass Index
timeFrame: 12 months minus baseline values
measure: Low-density Lipoprotein LDL Cholesterol
timeFrame: 12 months minus baseline values
measure: High-density Lipoprotein HDL Cholesterol
timeFrame: 12 months minus baseline values
measure: Triglycerides
timeFrame: 12 months minus baseline values
measure: Serum Total Cholesterol
timeFrame: 12 months minus baseline values
measure: High Sensitive C-reactive Protein-hsCRP
timeFrame: 12 months minus baseline values
measure: Serum Total Protein
timeFrame: 12 months minus baseline values
measure: eGFR
timeFrame: 12 months minus baseline values
measure: UACR
timeFrame: 12 months minus baseline values
measure: KDQOL-Symptom/Problem
timeFrame: 12 months minus baseline values
measure: KDQOL-EKD
timeFrame: 12 months minus baseline values
measure: KDQOL-BKD
timeFrame: 12 months minus baseline values
measure: KDQOL-SF12 Physical Score
timeFrame: 12 months minus baseline values
measure: KDQOL-SF12 Mental Score
timeFrame: 12 months minus baseline values
measure: 8-Item Morisky Score
timeFrame: 12 months minus baseline values
Other outcomes:
Locations:
Study officials:
References:
citation: Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015.
citation: Newman S, Cheng T, Ghahate DM, Bobelu J, Sandy P, Faber T, Shah VO. Assessing knowledge and attitudes of diabetes in Zuni Indians using a culture-centered approach. PLoS One. 2014 Jun 11;9(6):e99614. doi: 10.1371/journal.pone.0099614. eCollection 2014.
citation: Shah VO, Ghahate DM, Bobelu J, Sandy P, Newman S, Helitzer DL, Faber T, Zager P. Identifying barriers to healthcare to reduce health disparity in Zuni Indians using focus group conducted by community health workers. Clin Transl Sci. 2014 Feb;7(1):6-11. doi: 10.1111/cts.12127. Epub 2013 Nov 8.
citation: MacCluer JW, Scavini M, Shah VO, Cole SA, Laston SL, Voruganti VS, Paine SS, Eaton AJ, Comuzzie AG, Tentori F, Pathak DR, Bobelu A, Bobelu J, Ghahate D, Waikaniwa M, Zager PG. Heritability of measures of kidney disease among Zuni Indians: the Zuni Kidney Project. Am J Kidney Dis. 2010 Aug;56(2):289-302. doi: 10.1053/j.ajkd.2010.03.012. Epub 2010 Jun 19.
citation: Nelson RG, Pankratz VS, Ghahate DM, Bobelu J, Faber T, Shah VO. Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial. Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1801-1809. doi: 10.2215/CJN.06910618. Epub 2018 Nov 15.
citation: Cukor D, Cohen LM, Cope EL, Ghahramani N, Hedayati SS, Hynes DM, Shah VO, Tentori F, Unruh M, Bobelu J, Cohen S, Dember LM, Faber T, Fischer MJ, Gallardo R, Germain MJ, Ghahate D, Grote N, Hartwell L, Heagerty P, Kimmel PL, Kutner N, Lawson S, Marr L, Nelson RG, Porter AC, Sandy P, Struminger BB, Subramanian L, Weisbord S, Young B, Mehrotra R. Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1703-1712. doi: 10.2215/CJN.09780915. Epub 2016 May 19.