Home-Based Kidney Care in Native American's of New Mexico (HBKC)

• ClinicalTrials.gov Identifier: NCT03179085
• Recruitment Status: Active, not recruiting
• First Posted: June 7, 2017
• Last Update Posted: May 24, 2022
• Sponsor: University of New Mexico
• Collaborator: Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC)
• Information provided by (Responsible Party): Vallabh O Shah, University of New Mexico

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases	Behavioral: Home-Based Kidney Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation
• Actual Study Start Date: August 22, 2017
• Estimated Primary Completion Date: December 1, 2022
• Estimated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care / Delayed Intervention; Participants randomized to the control group will receive usual care by their provider for 12 months. They will also attend one group class taught by CHRs in which they will learn basic information about diabetes prevention. 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 12 months of usual care, patients will enter into the delayed intervention where they will complete 12 months of Home-Based Kidney Care (HBKC).	Behavioral: Home-Based Kidney Care; All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (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.
Experimental: Home-Based Kidney Care Intervention; 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. Each visit will last 30 minutes to one hour and participant preference will be incorporated into the HBKC intervention arm by allowing participants to prioritize the order in which curriculum topic areas will be 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.	Behavioral: Home-Based Kidney Care; All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (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.

Outcome Measures

Primary Outcome Measures :

1. The Patient Activation Measure (PAM) [ Time Frame: 12 months ]
   Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare.

Secondary Outcome Measures :

1. Diabetes lab measures [ Time Frame: 12 months ]
   changes in clinical values
2. Kidney disease lab measures [ Time Frame: 12 months ]
   changes in clinical values
3. Blood pressure [ Time Frame: 12 months ]
   changes in clinical values
4. Lipid profile [ Time Frame: 12 months ]
   changes in clinical values
5. Clinical Phenotype of Inflammation [ Time Frame: 12 months ]
   changes in the value of marker of inflammation
6. Waist Circumference [ Time Frame: 12 months ]
   changes in the value of waist circumference
7. Psychological measures [ Time Frame: 12 months ]
   Changes in kidney disease specific quality of life (KDQOL) measures
8. Nutritional Measures [ Time Frame: 12 months ]
   Changes in 24 hours recall of diet questionnaire

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of New Mexico

Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC)

Investigators

• Principal Investigator: Vallabh Shah, PhD; University of New Mexico

More Information

Publications:

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):1703-12. doi: 10.2215/CJN.09780915. Epub 2016 May 19.

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.

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.

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.

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.

• Responsible Party: Vallabh O Shah, Professor, University of New Mexico
• ClinicalTrials.gov Identifier: NCT03179085
• Other Study ID Numbers: 16-344
• First Posted: June 7, 2017
• Last Update Posted: May 24, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Anonymized data will be available to share once the tribal leadership approves it.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vallabh O Shah, University of New Mexico:

Diabetes; American Indians; Disparity; microalbuminuria; Telemedicine; Community health representative (CHR); Patient Activation Measure (PAM); Home base kidney care

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency