Symptom Monitoring in Hemodialysis

NARecruitingINTERVENTIONAL
Enrollment

2,400

Participants

Timeline

Start Date

June 24, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

September 30, 2027

Conditions
End Stage Kidney Disease
Interventions
BEHAVIORAL

Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)

Dialysis clinics randomized to the SMaRRT-HD group will use the SMaRRT-HD system to capture patient-reported symptoms and support clinician follow-up. The online system includes the patient symptom ePROM surveys, clinician real-time email alerts, clinician guidances for symptom management, and patient-facing symptom reports as well as an administrative dashboard supporting management of trial participants at clinics using SMaRRT-HD. Designated clinic personnel (i.e., patient care technicians and nurses) will receive training on how to use the system to administer the symptom ePROM surveys to patients on tablet computers. Designated clinic nurses and medical providers will receive training on how to access guidances for symptom management and patient-facing symptom reports in the SMaRRT-HD system. For trial participants in SMaRRT-HD clinics, the SMaRRT-HD system will be implemented in addition to the Usual Care approach to symptom monitoring.

BEHAVIORAL

Usual Care

Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a CMS-mandated Health-Related Quality of Life (HRQOL) survey that includes questions about symptoms.

Trial Locations (1)

02451

RECRUITING

Fresenius Medical Care, Waltham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Duke University

OTHER

collaborator

University of New Mexico

OTHER

collaborator

Fresenius Medical Care North America

INDUSTRY

collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Pennsylvania

OTHER

NCT05738330 - Symptom Monitoring in Hemodialysis | Biotech Hunter | Biotech Hunter