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End Stage Kidney DiseaseSMaRRT-HDNCT05738330

Symptom Monitoring in Hemodialysis

A study testing Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) in people with End Stage Kidney Disease, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Kidney Disease
What is being tested?
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteUnited States
Study dates
24 Jun 2023to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Fresenius Medical Care

    Waltham, Massachusetts, 02451

    Cassandra Bowman, MHA, 919-445-6790, Cassandra_Bowman@unc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD), Usual Care
Keywords
End stage kidney disease, Kidney, Hemodialysis, Dialysis, Symptom monitoring, Electronic Patient-Reported Outcome Measure (ePROM)
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Usual CareBehavioural

    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.

Study groups in NCT05738330
Study groupRoleWhat they receive
SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)Active comparatorDialysis 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.
Receives: Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
Usual CareActive comparatorDialysis 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.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 months, 12 months

Secondary outcomes (31)
  1. 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.

    Measured: Baseline, 6 months, 12 months

  2. Post-dialysis recovery time (Effectiveness)

    Recovery time question

    Measured: Baseline, 6 months, 12 months

  3. 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.

    Measured: Baseline, 6 months, 12 months

  4. 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.

    Measured: Baseline, 6 months, 12 months

  5. 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.

    Measured: Baseline, 6 months, 12 months

  6. 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.

    Measured: Baseline, 6 months, 12 months

  7. 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.

    Measured: Baseline, 6 months, 12 months

  8. Hospitalizations (Effectiveness)

    Hospitalization rate

    Measured: Duration of active 12 month study participation plus 6 months; 18 months total

  9. Mortality (Effectiveness)

    Mortality rate

    Measured: Duration of active 12 month study participation plus 6 months; 18 months total

  10. Missed dialysis sessions (Effectiveness)

    The number of missed dialysis sessions during participation in the the trial.

    Measured: Duration of active 12 month study participation

  11. Shortened dialysis sessions (Effectiveness)

    The number of shortened dialysis sessions during participation in the the trial.

    Measured: Duration of active 12 month study participation

  12. Penetration (Implementation)

    SMaRRT-HD completion rates collected from the SMaRRT-HD system and KDQOL™-36 completion rates collected from the dialysis medical record

    Measured: Duration of active 12 month study participation

  13. Fidelity (Implementation); Clinical action after PROM use; All Clinics

    Evidence in the dialysis medical record of clinician action in response to a reported symptom.

    Measured: Duration of active 12 month study participation

  14. 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.

    Measured: Baseline, 6 months, and 12 months

  15. 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.

    Measured: 6 months, and 12 months

  16. 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.

    Measured: Duration of active 12 month study participation

  17. 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.

    Measured: Duration of active 12 month study participation

  18. 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.

    Measured: Baseline, 6 months, and 12 months

  19. 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.

    Measured: 6 months and 12 months

  20. 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.

    Measured: 6 months and 12 months

  21. 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.

    Measured: 6 months and 12 months

  22. 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.

    Measured: 6 months and 12 months

  23. 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.

    Measured: 6 months and 12 months

  24. 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.

    Measured: 6 months and 12 months

  25. 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.

    Measured: 6 months and 12 months

  26. 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.

    Measured: 6 months and 12 months

  27. 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.

    Measured: 6 months and 12 months

  28. 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.

    Measured: 6 months and 12 months

  29. 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.

    Measured: Interviews will be conducted before the optimization phase and after the end of the trial.

  30. 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.

    Measured: 6 months and 12 months

  31. 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.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start24 Jun 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design is a multi-center cluster-randomized trial with randomization performed at the level of the dialysis clinic. Dialysis clinics will be assigned to either the SMaRRT-HD group (18 clinics) or the Usual Care group (18 clinics). SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a patient reported outcome measure (PROM) and 2) supported clinician follow-up consisting of symptom alerts, symptom management guidance, and tracking reports to share with patients. Dialysis clinics assigned to Usual Care will not use SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical interactions with participants and by administering a HRQOL survey. The trial uses a hybrid Type 1 effectiveness-implementation approach with effectiveness of the intervention assessed with patient-reported outcomes and biomedical outcomes, and implementation assessed with integrated qualitative and quantitative outcomes.
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738330
Sponsor's protocol ID
852661
Acronym
SMaRRT-HD
Status last verified
Nov 2025
First submitted
31 Jan 2023
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 40889553

Questions about this trial

What is this clinical trial studying?

A study testing Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) in people with End Stage Kidney Disease, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of dialysis-associated symptoms (Effectiveness) (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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