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Chronic Kidney DiseasesNCT03179085

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

A study testing Home-Based Kidney Care in people with Chronic Kidney Diseases, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Home-Based Kidney Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
529 participants
Where
1 siteUnited States
Study dates
22 Aug 2017to 1 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

Official title: Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation

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.

Read the 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.

Being tested
Home-Based Kidney Care
Keywords
Diabetes, American Indians, Disparity, microalbuminuria, Telemedicine, Community health representative (CHR), Patient Activation Measure (PAM), Home base kidney care
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based Kidney CareBehavioural

    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.

Study groups in NCT03179085
Study groupRoleWhat they receive
Usual Care / Delayed InterventionActive comparatorParticipants 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).
Receives: Behavioral: Home-Based Kidney Care
Home-Based Kidney Care InterventionExperimentalAll 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.
Receives: Behavioral: Home-Based Kidney Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6 and 12 months

Secondary outcomes (7)
  1. HbA1c

    Hemoglobin A1C measured as percent of glycosylated high hemoglobin cells

    Measured: Baseline. Change from baseline at 6 and 12 months

  2. Blood Glucose Levels

    amount of glucose in the blood measured as mg/dL - milligrams per deciliter

    Measured: Baseline. Change from baseline at 6 and 12 months

  3. HDL

    High density lipoprotein as mg/dL - milligrams per deciliter

    Measured: Baseline. Change from baseline at 6 and 12 months

  4. LDL

    Low density lipoprotein as mg/dL - milligrams per deciliter

    Measured: Baseline. Change from baseline at 6 and 12 months

  5. Creatinine

    Serum creatinine measured as mg/dL - milligrams per deciliter

    Measured: Baseline. Change from baseline at 6 and 12 months

  6. SF12 Physical

    KDQOL Short Form 12 (SF12) Physical functioning T score: normal mean=50, normal standard deviation=10. Higher values is higher quality of life.

    Measured: Baseline. Change from baseline at 6 and 12 months

  7. SF12 Mental

    KDQOL Short Form 12 (SF12) Mental functioning T score: normal mean=50, normal standard deviation=10. Higher values is higher quality of life.

    Measured: Baseline. Change from baseline at 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start22 Aug 2017
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
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.
Masking
None (open label)
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179085
Sponsor's protocol ID
16-344
Status last verified
Apr 2025
First submitted
2 Jun 2017
Last updated
8 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized data will be available to share once the tribal leadership approves it.

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):1703-1712. doi: 10.2215/CJN.09780915. Epub 2016 May 19.

    PubMed 27197911
  • 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.

    PubMed 25954817
  • 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.

    PubMed 24919064
  • 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.

    PubMed 24528897
  • 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.

    PubMed 20646805

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Kidney Care in people with Chronic Kidney Diseases, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Patient Activation Measure (PAM) (time frame: Baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179085, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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