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Home-Based Kidney Care for Chronic Kidney Disease

N/A
Waitlist Available
Led By Vallabh Shah, PhD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(2) age 21 to 80 years
(4) diagnosed diabetics or HbA1c >7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test if home-based care can decrease the risk for the development and progression of CKD, especially among minority populations who are at increased risk.

Who is the study for?
The HBKC trial is for Native Americans in New Mexico aged 21-80 with chronic kidney disease, often due to obesity or diabetes. Participants must have a BMI over 27 and certain lab results indicating kidney issues. It's not for those on dialysis, with a recent transplant, short life expectancy, pregnancy, or without consent.Check my eligibility
What is being tested?
This study tests if home-based care by health workers and medical faculty can slow down kidney disease progression. The care includes early interventions tailored to individuals' needs to prevent the condition from worsening to ESRD.See study design
What are the potential side effects?
Since this trial involves non-medical intervention through home-based care rather than drugs, side effects are minimal but may include discomfort from lifestyle changes or stress from frequent health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.
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I am diabetic or my HbA1c level is above 7.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Patient Activation Measure (PAM)
Secondary outcome measures
Blood pressure
Clinical Phenotype of Inflammation
Diabetes lab measures
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Home-Based Kidney Care InterventionExperimental Treatment1 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.
Group II: Usual Care / Delayed InterventionActive Control1 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).

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,583 Total Patients Enrolled
Albuquerque Area Southwest Tribal Epidemiology Center (AASTEC)UNKNOWN
Vallabh Shah, PhDPrincipal InvestigatorUniversity of New Mexico
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

I am interested in enrolling for this clinical research, what are the next steps?

"The ideal candidate for this trial are those aged 21-80 suffering from chronic kidney disease. Out of these 206 participants, they must live in a household with only one other individual and have a negative pregnancy test (for women of child-bearing potential). Lastly, their Body Mass Index (BMI) must be greater than 27 kg/m2 and their UACR must be greater than or equal to 30."

Answered by AI

Does the age limit for this clinical trial include patients over 60 years old?

"The ideal candidate for this study is somebody who is between the ages of 21 and 80."

Answered by AI
Recent research and studies
Clinical Journal of the American Society of NephrologyJournal
Patient and Other Stakeholder Engagement in Patient-centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases
Cukor, Daniel, Lewis M. Cohen, Elizabeth L. Cope, Nasrollah Ghahramani, S. Susan Hedayati, Denise M. Hynes, Vallabh O. Shah, et al.. 2016. “Patient and Other Stakeholder Engagement in Patient-centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases”. Clinical Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.2215/cjn.09780915.
PLoS ONEJournal
Assessing Knowledge and Attitudes of Diabetes in Zuni Indians Using a Culture-centered Approach
Newman, Sara, Terri Cheng, Donica M. Ghahate, Jeanette Bobelu, Phillip Sandy, Thomas Faber, and Vallabh O. Shah. 2014. “Assessing Knowledge and Attitudes of Diabetes in Zuni Indians Using a Culture-centered Approach”. Edited by Hamid Reza Baradaran. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0099614.
American Journal of Kidney DiseasesJournal
Heritability of Measures of Kidney Disease Among Zuni Indians: The Zuni Kidney Project
MacCluer, Jean W., Marina Scavini, Vallabh O. Shah, Shelley A. Cole, Sandra L. Laston, V. Saroja Voruganti, Susan S. Paine, et al.. 2010. “Heritability of Measures of Kidney Disease Among Zuni Indians: The Zuni Kidney Project”. American Journal of Kidney Diseases. Elsevier BV. doi:10.1053/j.ajkd.2010.03.012.
Plos OneJournal
A Home-based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators Among Zuni Indians
Shah, Vallabh O., Casey Carroll, Ryan Mals, Donica Ghahate, Jeanette Bobelu, Phillip Sandy, Kathleen Colleran, Ronald Schrader, Thomas Faber, and Mark R. Burge. 2015. “A Home-based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators Among Zuni Indians”. Edited by Stephen L Atkin. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0125820.
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