Symptom Monitoring in Hemodialysis (SMaRRT-HD)

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. 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 Health Related Quality of Life survey that includes questions about symptoms.

Study Overview

• Status: Recruiting
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD); Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • Fresenius Medical Care
      • Contact: Cassandra Bowman, MHA; Phone Number: 919-445-6790; Email: Cassandra_Bowman@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Treatment with hemodialysis at a participating dialysis clinic
• English or Spanish speaking

Exclusion Criteria:

• Not willing to report their symptoms using the SMaRRT-HD platform
• Not willing to share clinically acquired data with the research team
• Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
• Incarceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis); Dialysis clinics randomized to SMaRRT-HD will implement the SMaRRT-HD symptom monitoring system. SMaRRT-HD consists of 1) tablet-based symptom reporting using a patient reported outcome measure (PROM) and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of dialysis-associated symptoms (Effectiveness)	This outcome will be assessed as change in the Dialysis Symptom Index-Severity Score over 12 months (primary endpoint). Participants are asked whether or not they experienced symptoms during the past week. If the response is yes, the participant is asked to indicate "How much did it bother you?". Lowest score - 0; Highest score - 150. A higher score indicates a worse outcome.	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (Effectiveness)	EuroQOL 5D-5L (EQ-5D-5L) Participants are asked about 5 different domains that can affect people's quality of life (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression). Participants respond on a scale of 1 to 5 where 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. An EQ-5D summary index is derived by applying a formula (developed by EuroQol Group) that attaches values (weights) to each of the levels in each dimension. A higher score indicates a better outcome.	Baseline, 6 months, 12 months
Post-dialysis recovery time (Effectiveness)	Recovery time question	Baseline, 6 months, 12 months
Pain interference (Effectiveness)	Brief Pain Inventory (BPI)- Interference Participants are asked how much, during the past week, pain has interfered with different activities. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score indicates a worse outcome.	Baseline, 6 months, 12 months
Anxiety (Effectiveness)	Generalized Anxiety Disorder (GAD)-7 Participants are asked to report how often during the past 2 weeks they have had symptoms or experiences. Lowest score - 0; Highest score - 21. Higher score indicates a worse outcome.	Baseline, 6 months, 12 months
Depression (Effectiveness)	Patient Health Questionnaire (PHQ)-8 Participants are asked to report how much during the last 2 weeks they have experienced problems. Lowest score - 0; Highest score - 24. Higher score indicates a worse outcome.	Baseline, 6 months, 12 months
Hospitalizations (Effectiveness)	Hospitalization rate	Duration of active 12 month study participation plus 6 months; 18 months total
Mortality (Effectiveness)	Mortality rate	Duration of active 12 month study participation plus 6 months; 18 months total
Missed dialysis sessions (Effectiveness)	The number of missed dialysis sessions during participation in the the trial.	Duration of active 12 month study participation
Shortened dialysis sessions (Effectiveness)	The number of shortened dialysis sessions during participation in the the trial.	Duration of active 12 month study participation
Penetration (Implementation)	SMaRRT-HD completion rates collected from the SMaRRT-HD system and KDQOL™-36 completion rates collected from the dialysis medical record	Duration of active 12 month study participation
Fidelity (Implementation); Clinical action after PROM use; All Clinics	Evidence in the dialysis medical record of clinician action in response to a reported symptom.	Duration of active 12 month study participation
Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics	Patient response to a Computer-Assisted Telephone Interview-administered question about the occurrence of clinician follow-up of a reported symptom.	Baseline, 6 months, and 12 months
Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics	Patient, clinic personnel, and medical provider responses to survey questions about the occurrence of clinician follow-up of a reported symptom.	6 months, and 12 months
Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, evidence in the SMaRRT-HD system of clinician access of symptom guidances within 7 days of each administration of the SMaRRT-HD symptom ePROM.	Duration of active 12 month study participation
Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, evidence in the SMaRRT-HD system of clinician access of symptom reports within 7 days of each administration of the SMaRRT-HD symptom ePROM.	Duration of active 12 month study participation
Acceptability (Implementation); Surveys; All Clinics	Patient, clinic personnel, and medical provider responses to survey questions about the acceptability of patient-dialysis care team communication about symptoms.	6 months and 12 months
Acceptability (Implementation); Interviews; All Clinics	Patient, clinic personnel, and medical provider responses to interview questions about the acceptability of patient-dialysis care team communication about symptoms.	6 months and 12 months
Acceptability (Implementation); Surveys; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the acceptability of the SMaRRT-HD system components.	6 months and 12 months
Acceptability (Implementation); Interviews; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the acceptability of the SMaRRT-HD system components.	6 months and 12 months
Appropriateness (Implementation); Surveys; All Clinics	Patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of patient-dialysis care team communication about symptoms.	6 months and 12 months
Appropriateness (Implementation); Interviews; All Clinics	Patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of patient-dialysis care team communication about symptoms.	6 months and 12 months
Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of the SMaRRT-HD system components.	6 months and 12 months
Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of the SMaRRT-HD system components.	6 months and 12 months
Feasibility (Implementation); Surveys; All Clinics	Patient, clinic personnel, and medical provider responses to survey questions about feasibility of patient-dialysis care team communication about symptoms.	6 months and 12 months
Feasibility (Implementation); Interviews; All Clinics	Patient, clinic personnel, and medical provider responses to interview questions about feasibility of patient-dialysis care team communication about symptoms.	6 months and 12 months
Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders	Corporate leader responses to interview questions about the importance, feasibility, and potential for sustainability of regularly administering PROMs in routine dialysis care.	Interviews will be conducted before the optimization phase and after the end of the trial.
Feasibility (Implementation); Surveys; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the feasibility of the SMaRRT-HD system components.	6 months and 12 months
Feasibility (Implementation); Interviews; SMaRRT-HD Clinics	In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the feasibility of the SMaRRT-HD system components.	6 months and 12 months
Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics	Patient response to a Computer-Assisted Telephone Interview-administered question about the receipt of symptom summaries.	Baseline, 6 months, and 12 months
Fatigue (Effectiveness)	PROMIS Fatigue SF 6a Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.	Baseline, 6 months, 12 months
Healthcare Engagement (Effectiveness)	Healthcare Engagement - Short Form 8a (PHE-8a) Participants are asked to respond to statements with how true each statement is for them at the time the questionnaire is administered. Responses range from "Not at all true" to "Very true". The PHE-8a uses item response theory-based scoring converted to standardized T-scores. A higher score indicates a better outcome.	Baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of patient-clinician communication (Effectiveness)	In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS)- Communication and Caring Domain	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute; Duke University; University of North Carolina, Chapel Hill; University of New Mexico; Fresenius Medical Care North America
• Investigators: Principal Investigator: Laura Dember, MD, University of Pennsylvania; Principal Investigator: Jennifer Flythe, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Flythe JE, Picataggio CB, Bernardo L, Dalrymple LS, Kossmann RJ, DeWalt DA, Hanson LC, Wang V, Unruh ML, Hsu JY, Dember LM. Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis. Contemp Clin Trials. 2025 Oct;157:108058. doi: 10.1016/j.cct.2025.108058. Epub 2025 Aug 30.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Dialysis; Hemodialysis; Kidney; End stage kidney disease; Symptom monitoring; Electronic Patient-Reported Outcome Measure (ePROM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: 852661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The primary method by which data will be shared with the scientific community will be through peer-reviewed publications and presentations at scientific and professional society meetings. A final report of the research results will be submitted to PCORI for peer review in accordance with the PCORI Peer Review and Findings Release Process. Plain language summaries of the results will be provided to all participating dialysis clinics for distribution to all patients, personnel, and medical providers. Data Sharing will be consistent with PCORI's Policy for Data Management and Data Sharing and as permitted by the project contracts and data use agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No