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?

Kidney failure occurs when the kidneys no longer work well enough to meet the body’s day-to-day needs. People with kidney failure need a transplant or dialysis. Dialysis is a treatment to remove harmful waste and excess fluid from the body. Although dialysis can save lives, it can be hard on patients. Many people treated with dialysis have symptoms such as muscle cramps, itching, and fatigue. These symptoms can worsen patients’ quality of life.

In regular dialysis care, patients complete surveys about their well-being, including symptoms, at least once a year. But care teams don’t have systems to help them follow up with patients about their reported symptoms. Surveying patients about their symptoms more often and helping care teams follow up on their responses may improve patients’ symptoms and quality of life.

In this study, the research team is comparing two ways to monitor and address patient symptoms during dialysis:

  • Usual care. Once a year, patients complete a survey on their quality of life that includes questions about symptoms.
  • Usual care plus SMaRRT-HD. In addition to usual care, twice a month, patients use an electronic system called SMaRRT-HD to report their symptoms. The system alerts care teams about patients’ symptoms and provides suggestions for how to manage them. Care teams can use the system to see reports of patients’ symptoms over time and are encouraged to share these reports with patients.

Who can this research help?

Results may help dialysis organizations when considering ways to monitor and address patients’ symptoms during dialysis.

What is the research team doing?

The research team is working with 30 dialysis clinics across the United States to enroll adults with kidney failure who are receiving dialysis. The team is assigning clinics by chance to provide usual care with or without SMaRRT-HD. Enrolled patients are receiving the symptom monitoring approach assigned to their clinic.

Over one year, the research team is looking at changes in outcomes such as patients’ symptoms, quality of life, and healthcare use. The team is also interviewing and surveying patients, clinic staff, and clinicians, such as doctors and nurse practitioners, about their experiences using SMaRRT-HD.

Patients, dialysis clinic staff, dialysis organization leaders, clinicians, and health insurers are helping to plan and conduct this study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 2,400 adults ages 18 and older receiving treatment with hemodialysis at a participating dialysis clinic
  • Usual care
  • Usual care plus SMaRRT-HD

Primary: severity of symptoms

Secondary: health-related quality of life, post-dialysis recovery time, fatigue, pain interference, anxiety, depression, patient activation, hospitalizations, missed dialysis sessions, shortened dialysis sessions

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 1-year follow-up for primary outcome

*Increase Diversity and Advance Health Equity Funding Supplement
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) studies to leverage meaningful engagement of affected/relevant communities to ensure that a diverse and inclusive study population can be achieved.

Project Information

Jennifer Flythe, MD, MPH
Laura Dember, MD
The University of North Carolina at Chapel Hill
Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Key Dates

March 2022
October 2028


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
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: September 28, 2023