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

NCT03179085 | Completed Results

• 1 other identifier: 16-344
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Patient Activation Measure (PAM)

  Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. PAM total scores have a theoretical range from 0 to 100, with higher scores representing greater patient activation.

  Baseline, 6 and 12 months

Secondary Outcomes (7)

• HbA1c

  Baseline. Change from baseline at 6 and 12 months

• Blood Glucose Levels

  Baseline. Change from baseline at 6 and 12 months

• HDL

  Baseline. Change from baseline at 6 and 12 months

• LDL

  Baseline. Change from baseline at 6 and 12 months

• Creatinine

  Baseline. Change from baseline at 6 and 12 months

Study Arms (2)

Usual Care / Delayed Intervention

ACTIVE COMPARATOR

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

Home-Based Kidney Care Intervention

EXPERIMENTAL

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

Interventions

Home-Based Kidney Care BEHAVIORAL

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.

Home-Based Kidney Care Intervention; Usual Care / Delayed Intervention

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (5)

• 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.

  PMID: 27197911 BACKGROUND

• 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.

  PMID: 25954817 BACKGROUND

• 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.

  PMID: 24919064 BACKGROUND

• 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.

  PMID: 24528897 BACKGROUND

• 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.

  PMID: 20646805 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Vallabh Shah, PhD. Principal Investigator
• Organization: University of New Mexico Health Sciences Center

VShah@salud.unm.edu

505-272-9615

Study Officials

• Vallabh Shah, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 7, 2017
• Study Start: August 22, 2017
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Locations

US (1)