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NCT Number: NCT03179085

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

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.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The Patient Activation Measure (PAM)

    Time frame: Baseline, 6 and 12 months

    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.

Secondary outcomes

  1. HbA1c

    Time frame: Baseline. Change from baseline at 6 and 12 months

    Hemoglobin A1C measured as percent of glycosylated high hemoglobin cells

  2. Blood Glucose Levels

    Time frame: Baseline. Change from baseline at 6 and 12 months

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

  3. HDL

    Time frame: Baseline. Change from baseline at 6 and 12 months

    High density lipoprotein as mg/dL - milligrams per deciliter

  4. LDL

    Time frame: Baseline. Change from baseline at 6 and 12 months

    Low density lipoprotein as mg/dL - milligrams per deciliter

  5. Creatinine

    Time frame: Baseline. Change from baseline at 6 and 12 months

    Serum creatinine measured as mg/dL - milligrams per deciliter

  6. SF12 Physical

    Time frame: Baseline. Change from baseline at 6 and 12 months

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

  7. SF12 Mental

    Time frame: Baseline. Change from baseline at 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2017
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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