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.
COVID-19-Related Project EnhancementThe goal of this project’s enhancement is to determine how the COVID-19 pandemic has influenced the physical and mental health of vulnerable rural Native Americans living with chronic kidney disease (CKD). The research team aims to determine the influence of COVID-19—and the healthcare system’s response to it—on disparities in access to care among American Indians with diabetes and CKD participating in the original study on home-based kidney care; evaluate disparities in key patient health outcomes on diabetes and CKD due to COVID-19-related disruptions in care delivery, and engage patients and other stakeholders in interpreting and disseminating findings to develop patient-centered intervention tools to improve quality of life and healthcare delivery, especially in response to the COVID-19 pandemic. Enhancement Award Amount: $282,877* |
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 |
|
| 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 |
 |
1-year follow-up for primary outcomes |
Project Details
Telemedicine
Other Health Services Interventions
Training and Education Interventions
Racial/Ethnic Minorities
COVID-19-Related Project Enhancement
Partners
Patient/Caregiver Partners
Other Stakeholder Partners
*All proposed enhancement projects, including requested project plans, budgets and milestone schedules, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award modification.