Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Healthy kidneys filter the blood and remove waste. When kidneys are damaged, waste builds up and increases a person’s risk for heart disease or stroke. Chronic kidney disease, or CKD, is any condition that causes kidney damage over time. CKD can’t be cured, and it can lead to kidney failure and death. About 14 percent of Americans have some form of CKD, but CKD is more common in people who are Native American, black, or Hispanic.

Early treatment, including making healthy food choices and controlling blood pressure, can slow CKD. In this study, the research team wants to know if at-home education delivered by community health workers can help people with CKD feel more confident about managing their CKD and can help them take steps that slow its progress. The team is testing this approach with people from four Native American communities in New Mexico, using education that fits their cultures.

Who can this research help?

Health systems that care for Native Americans can use information from this study as they consider how best to plan education and care for people with CKD.

What is the research team doing?

The research team is recruiting 240 people with CKD in four Native American communities. The team is assigning people with CKD by chance to one of two groups. In the first group, a community health worker meets with each patient at home at least once every two weeks for one year. Each visit lasts 30 to 60 minutes and covers topics such as

  • Education about kidneys
  • Weight control
  • Exercise
  • Healthy eating
  • Taking medicine to help control CKD
  • Managing stress
  • Controlling blood pressure
  • Alcohol and substance use
  • Stopping smoking

People in the second group get regular treatment from their doctor. After one year, they also get at-home kidney care.

The research team is following up with patients after one year to find out what patients know about CKD and how confident they are managing their CKD. The team is also looking at whether people in the two groups have differences in blood pressure, cholesterol, signs of diabetes or CKD progression, and diet; whether they take medicine as prescribed; and their quality of life.

Leaders from the Native American communities and health organizations are working with the research team to plan the study and design the at-home education plan. 

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Adults ages 21 to 80 who have diabetes or HbA1c>7 and BMI >27 kg/m2 and live in one of four Native American communities in New Mexico
Interventions/
Comparators
  • At-home kidney care
  • Usual care for 12 months, then home-based kidney care
Outcomes

Primary: Patient Activation Measure

Secondary: lab measures for diabetes and kidney disease, blood pressure, lipid profile, waist circumference, changes in quality of life specific to kidney disease, changes in 24-hour recall of diet questionnaire

Timeframe 1-year follow-up for primary outcomes

Project Information

Vallabh O. Shah, PhD
University of New Mexico Health Sciences Center
$2,546,128
Home-Based Chronic Kidney Disease (CKD) Care in Native Americans of New Mexico: A Disruptive Innovation

Key Dates

July 2016
July 2022
2016

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022