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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03179085

Enrollment

529

Registered

2017-06-07

Start date

2017-08-22

Completion date

2024-08-01

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

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

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.

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.

Interventions

BEHAVIORALHome-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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

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. 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.

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The Patient Activation Measure (PAM)	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

Measure	Time frame	Description
Blood Glucose Levels	Baseline. Change from baseline at 6 and 12 months	amount of glucose in the blood measured as mg/dL - milligrams per deciliter
HDL	Baseline. Change from baseline at 6 and 12 months	High density lipoprotein as mg/dL - milligrams per deciliter
LDL	Baseline. Change from baseline at 6 and 12 months	Low density lipoprotein as mg/dL - milligrams per deciliter
HbA1c	Baseline. Change from baseline at 6 and 12 months	Hemoglobin A1C measured as percent of glycosylated high hemoglobin cells
SF12 Physical	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.
SF12 Mental	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.
Creatinine	Baseline. Change from baseline at 6 and 12 months	Serum creatinine measured as mg/dL - milligrams per deciliter

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

The study enrolled males and females who displayed evidence of diabetic chronic kidney disease and who: were age 21 to 80 years; had a negative pregnancy test in women of child-bearing potential; were diagnosed diabetics or HbA1c \>7; had BMI \>27 kg/m2, and had UACR \>=30 mg/g. Exclusion criteria: life expectancy \< 1 year; absence of reliable birth control in women of child-bearing potential; malignancy except non-melanoma skin cancer; blind; and unwilling or unable to give informed consent.

Participants by arm

Arm	Count
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). 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.	93
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. 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.	93
Total	186

Baseline characteristics

Characteristic	Home-Based Kidney Care Intervention	Total	Usual Care / Delayed Intervention
Age, Continuous	56.1 years STANDARD_DEVIATION 14.6	56.7 years STANDARD_DEVIATION 14.6	57.2 years STANDARD_DEVIATION 14.8
Race (NIH/OMB) American Indian or Alaska Native	93 Participants	186 Participants	93 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	52 Participants	104 Participants	52 Participants
Sex: Female, Male Male	40 Participants	80 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 93	0 / 93
other Total, other adverse events	0 / 93	0 / 93
serious Total, serious adverse events	0 / 93	0 / 93

Outcome results

Primary

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.

Time frame: Baseline, 6 and 12 months

Population: Missing PAM scores data and the number differ for each time point. Participants were invited to participate at each time point regardless of participation in other study periods. We note that this study took place during COVID 19 pandemic.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Usual Care / Delayed Intervention	The Patient Activation Measure (PAM)	Baseline PAM scores	60.8 score on a scale	Standard Error 2.12
Usual Care / Delayed Intervention	The Patient Activation Measure (PAM)	6-month change in PAM scores	1.73 score on a scale	Standard Error 1.64
Usual Care / Delayed Intervention	The Patient Activation Measure (PAM)	12-month change in PAM scores	2.28 score on a scale	Standard Error 2.05
Home-Based Kidney Care Intervention	The Patient Activation Measure (PAM)	Baseline PAM scores	61.5 score on a scale	Standard Error 2.06
Home-Based Kidney Care Intervention	The Patient Activation Measure (PAM)	6-month change in PAM scores	3.44 score on a scale	Standard Error 1.55
Home-Based Kidney Care Intervention	The Patient Activation Measure (PAM)	12-month change in PAM scores	3.59 score on a scale	Standard Error 1.94

Secondary