Clinical trial NCT03179085: Home-Based Kidney Care in Native American's of New Mexico (HBKC)
Official title: Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Diabetes
American Indians
Disparity
microalbuminuria
Telemedicine
Community health representative (CHR)
Patient Activation Measure (PAM)
Home base kidney care
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 529
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants randomized to control group will receive standard care for 12 months before entering into the delayed intervention. Participants randomized to the intervention will receive the intervention during the first 12 months.

We want to clarify that a total of 529 individuals were consented for participation in the study. These participants responded to screening questionnaires which included POC testing, Blood pressure, medical history and physical assessments. From those 529 participants, a total of 286 did not meet inclusion criteria for randomization and 57 declined further participation in the study. Therefore, we randomized 186 participants, 93 to the HBKC care intervention and 93 to the Delay Intervention.
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 risk for heart disease and death. The burden of chronic kidney disease is increased among minority populations compared to Caucasians. New Mexico American Indians are experiencing an epidemic of chronic kidney disease due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rates 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, the Albuquerque Area Indian Health Board and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.

Detailed description: Hypothesis:

Specific Aim 1: 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;

Specific 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);

Specific 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.

Study Outcomes: (1) The patient activation measures 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 New Mexico tribal leadership and the Albuquerque Area Indian Health Board, as well as the accessibility to 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:

* (1) live in a household with 1 participant
* (2) age 21 to 80 years
* (3) negative pregnancy test in women of child-bearing potential
* (4) diagnosed diabetics or HbA1c \>7
* (5) BMI \>27 kg/m2 and UACR of \>/= 30

Exclusion Criteria:

* (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
* (7) unwilling or unable to give informed consent.

Primary outcomes:
measure: The Patient Activation Measure (PAM)
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: Blood Glucose Levels
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: HDL
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: LDL
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: Creatinine
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: SF12 Physical
timeFrame: Baseline. Change from baseline at 6 and 12 months
measure: SF12 Mental
timeFrame: Baseline. Change from baseline at 6 and 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Vallabh Shah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.