Results Summary
What was the research about?
More than 30 million people in the United States have kidney disease. With this health problem, people’s kidneys stop working well or don’t work at all. It can be hard to manage kidney disease for people who have trouble getting health care.
Care may not be easy to get for the Zuni Indians of the Zuni Reservation in rural New Mexico. Getting to the health clinic can be hard. People often wait a long time to get the care they need.
In this study, the research team wanted to learn if an at-home education program would help Zuni adults with kidney disease have better knowledge, skills, and confidence to manage their illness. The team also looked at whether the program helped Zuni adults improve their quality of life and reduce risk factors for kidney disease. Risk factors include being overweight and having high blood sugar and high blood pressure.
The study compared a group of Zuni adults in the at-home program with a group of adults who were not in the program and who received care at the Indian Health Services, or IHS, clinic.
What were the results?
Compared with those who received care at the IHS clinic, Zuni adults in the at-home program had better
- Knowledge, skills, and confidence to manage kidney disease
- Quality of life related to mental health
Zuni adults in the at-home program reduced some risk factors for kidney disease, such as blood sugar levels and weight, more than adults who only went to the IHS clinic. For other risk factors, such as blood pressure, there were no differences between the two groups.
There was no difference between the two groups in quality of life related to physical health.
Who was in the study?
The study included 125 Zuni Indian adults living with kidney disease on the Zuni Reservation in rural New Mexico. Of these, 98 completed the 12-month study.
What did the research team do?
The team assigned people to one of two groups by chance. The first group received care through the at-home program. In this program, community health representatives visited Zuni adults with kidney disease in their homes every other week. The community health representatives were people from the Zuni community who worked as part of a clinical care team. At the home visits, they taught participants about exercise, healthy diet, and blood pressure. The community health representatives also did lab tests to check for kidney disease risk factors. For the first six months of the program, participants received text messages with reminders about healthy living. Every three months, participants went to a health class at the IHS clinic. Zuni tribal leaders and members from a Tribal Advisory Panel helped design this program.
Adults in the second group received their usual care at the IHS clinic. Adults in both groups took a survey at the start of the study and again 12 months later. The survey asked about people’s quality of life and their knowledge, skills, and confidence for managing kidney disease.
What were the limits of the study?
The study took place in one American Indian reservation in rural New Mexico. The results might be different for people in other places. The team didn’t look at which parts of the program might explain the changes they found.
Future research could see if the program works as well with a larger group of people with kidney disease. Researchers could also look more closely at each part of the program.
How can people use the results?
Clinics in rural areas could consider offering at-home programs with community health representatives to help patients with kidney disease.
Professional Abstract
Objective
To compare the effects of a home-based educational intervention delivered by community health representatives (CHRs) versus usual clinic-based care on patient activation, quality of life, and risk factors for chronic kidney disease (CKD) in adult Zuni Indians
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 125 adult Zuni Indians living with CKD on the Zuni reservation in rural New Mexico |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient activation, or the knowledge, skills, and confidence to effectively manage one’s health and health care Secondary: quality of life and clinical risk factors for CKD such as body mass index, hemoglobin A1c, high-sensitivity C-reactive protein, blood pressure, urine albumin-to-creatinine ratio, serum creatinine, estimated glomerular filtration rate |
| Timeframe | 12-month follow-up for primary outcome |
This small randomized controlled trial tested the comparative effectiveness of a home-based educational intervention delivered by CHRs as part of a clinical care team versus usual care provided by local Zuni Indian Health Service (IHS) clinics. The team designed the intervention with input from a Tribal Advisory Panel including Zuni community members, the Zuni Governor, the Tribal Council, and IHS.
The intervention consisted of biweekly home visits by CHRs who educated and trained participants in exercising, maintaining a healthy diet, and monitoring blood pressure. During these visits, CHRs also tested for CKD risk factors. For the first six months, the CHRs delivered Zuni culturally tailored motivational text messaging about healthier living. In addition, participants attended quarterly group sessions consisting of interactive discussions at the Zuni Health Initiative clinic. Participants in the usual care group received usual care at local Zuni IHS clinics.
The research team randomized 125 Zuni adults with moderate-to-severe CKD (estimated glomerular filtration rate <60 ml/min/1.73 m2 or urine albumin to creatinine ratio ≥30 mg/g) from households in which at least one person had participated in a prior study to either the intervention or usual care groups. Of these, 98 completed the study.
Shortly after enrollment and again 12 months later, the team collected clinical lab and survey data. Survey data included the 13-item Patient Activation Measure (PAM) and the 36-item Kidney Disease Quality of Life (KDQOL) questionnaire with the following subscales: the 12-item Short Form mental and physical health (SF-12), burden of kidney disease, effects of kidney disease, and symptoms and problems of kidney disease.
Results
At 12 months, compared with adults in the usual care group, those in the intervention group experienced greater improvement in patient activation, mental health quality of life, and three clinical risk factors for CKD. Body mass index in the intervention group decreased 1.07 kg/m2 more than in the usual care group (p=0.008). Hemoglobin A1c levels in the intervention group decreased 0.71% more than in the usual care group (p=0.012). The high-sensitivity C-reactive protein levels in the intervention group decreased by 4.3 mg/L compared with an increase of 4.6 mg/L in the usual care group (p<0.001).
The two groups did not differ significantly in the other KDQOL subscales examined or in blood pressure, urine albumin-to-creatinine ratio, serum creatinine, or estimated glomerular filtration rate.
Limitations
The study included a small sample of adults from one American Indian reservation in rural New Mexico. Findings from the study may not generalize to other communities. Further, the research team did not examine which components of the intervention may have contributed to the observed changes within the intervention group.
Conclusions and Relevance
Culturally appropriate home-based education from CHRs improved patient activation, mental health, and certain CKD risk factors among rural Zuni adults in this small study. Home-based education may be a promising approach for other adults with CKD who experience barriers to accessing health care.
Future Research Needs
A large randomized controlled trial could test the scalability of the intervention. Studies could also examine the effects of the various intervention components on patient activation and health.
Final Research Report
View this project's final research report.
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Vallabh O. Shah, PhD, talks about the impact of including key community members in his project.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
The awardee made the following revisions in response to peer review:
- The awardee revised the structure of the report to better tell the story of how the work in each aim led to the next aim. The awardee removed the parts of the aim 1 discussion that had confused reviewers. The awardee also revised the background section to focus on the evidence gap in disease burden and optimal care in chronic kidney disease.
- The awardee provided more information on stakeholder engagement by describing in detail the team’s long-standing collaboration with this American Indian community. The awardee explained that the study’s design and implementation involved close collaboration with this community.
- The awardee further explained its description of the study as both a randomized controlled trial, RCT, and a pilot study. The awardee clarified that the study uses a RCT design with pilot components, such as measuring the feasibility of testing the effect of the intervention on chronic kidney disease outcomes in future trials.
- The awardee defined the terms intent-to-treat analysis and per-protocol analysis. The awardee explained that in per-protocol analysis, it compared groups of patients who completed the study. The awardee further explained that in intent-to-treat analysis, it compared the intervention and control groups while including patients who had dropped out, with the assumption that those patients had no change in outcomes. The awardee treated this comparison as a sensitivity analysis.
- In the study limitations section, the awardee noted that this project was a pilot study but added that the awardee tried to account for baseline differences to make the findings as robust as possible. In all, the awardee described the results as tentative but promising.