Home-Based Kidney Care in Native American's of New Mexico (HBKC)
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 11/2/2017 |
| Start Date: | August 22, 2017 |
| End Date: | December 2020 |
| Contact: | Vallabh Shah, PhD |
| Email: | vshah@salud.unm.edu |
| Phone: | 505-272-9615 |
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.
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.
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.
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.
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.
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