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

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ClinicalTrials.gov Identifier: NCT03179085
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC)
Information provided by (Responsible Party):
Vallabh O Shah, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Behavioral: Home-Based Kidney Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 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).
Behavioral: 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.

Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. The Patient Activation Measure (PAM) [ Time Frame: 12 months ]
    Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare.


Secondary Outcome Measures :
  1. Diabetes lab measures [ Time Frame: 12 months ]
    changes in clinical values

  2. Kidney disease lab measures [ Time Frame: 12 months ]
    changes in clinical values

  3. Blood pressure [ Time Frame: 12 months ]
    changes in clinical values

  4. Lipid profile [ Time Frame: 12 months ]
    changes in clinical values

  5. Clinical Phenotype of Inflammation [ Time Frame: 12 months ]
    changes in the value of marker of inflammation

  6. Waist Circumference [ Time Frame: 12 months ]
    changes in the value of waist circumference

  7. Psychological measures [ Time Frame: 12 months ]
    Changes in kidney disease specific quality of life (KDQOL) measures

  8. Nutritional Measures [ Time Frame: 12 months ]
    Changes in 24 hours recall of diet questionnaire



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179085


Contacts
Contact: Vallabh Shah, PhD 505-272-9615 vshah@salud.unm.edu
Contact: Kevin English, PhD 505-764-0036 kenglish@aaihb.org

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Vallabh Shah, PhD    505-272-9615    vshah@salud.unm.edu   
Contact: Kevin English, PhD    505-764-0036    kenglish@aaihb.org   
Sponsors and Collaborators
University of New Mexico
Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC)
Investigators
Principal Investigator: Vallabh Shah, PhD University of New Mexico

Publications:

Responsible Party: Vallabh O Shah, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03179085     History of Changes
Other Study ID Numbers: 16-344
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data will be available to share once the tribal leadership approves it.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vallabh O Shah, University of New Mexico:
Diabetes
American Indians
Disparity
microalbuminuria
Telemedicine
Community health representative (CHR)
Patient Activation Measure (PAM)
Home base kidney care

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency