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.
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)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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
- Recruiting
Fresenius Medical Care
Waltham, Massachusetts, 02451
Cassandra Bowman, MHA, 919-445-6790, Cassandra_Bowman@unc.edu
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.
- Conditions
- End Stage Kidney Disease
- 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 group | Role | What they receive |
|---|---|---|
| SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis) | Active comparator | 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. Receives: Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Post-dialysis recovery time (Effectiveness)
Recovery time question
Measured: Baseline, 6 months, 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Hospitalizations (Effectiveness)
Hospitalization rate
Measured: Duration of active 12 month study participation plus 6 months; 18 months total
Mortality (Effectiveness)
Mortality rate
Measured: 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.
Measured: Duration of active 12 month study participation
Shortened dialysis sessions (Effectiveness)
The number of shortened dialysis sessions during participation in the the trial.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of active 12 month study participation
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
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
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
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
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
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
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
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
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
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
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
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.
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
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.
- First posted22 Feb 2023
- Study start24 Jun 2023
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Duke University, University of New Mexico, Fresenius Medical Care North America, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Laura Dember, MD, University of Pennsylvania
- Investigators
- Jennifer Flythe, MD, Principal investigator, University of North Carolina, Chapel HillLaura Dember, MD, Principal investigator, University of Pennsylvania
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
- ClinicalTrials.gov ID
- NCT05738330
- Acronym / sponsor ID
- SMaRRT-HD / 852661
- Conditions
- End Stage Kidney Disease
- Keywords
- End stage kidney disease, Kidney, Hemodialysis, Dialysis, Symptom monitoring, Electronic Patient-Reported Outcome Measure (ePROM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Duke University, University of New Mexico, Fresenius Medical Care North America, Patient-Centered Outcomes Research Institute
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis) | Active comparator | Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)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. |
| Usual Care | Active comparator | Behavioral: Usual CareDialysis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Treatment with hemodialysis at a participating dialysis clinic
- English or Spanish speaking
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis) |
| Usual CareDialysis 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. | Behavioural | Usual Care |
Primary outcome
Severity of dialysis-associated symptoms (Effectiveness)
Time frame: Baseline, 6 months, 12 months
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.
31 secondary outcomes
Health-related quality of life (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Post-dialysis recovery time (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Fatigue (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Pain interference (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Anxiety (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Depression (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Healthcare Engagement (Effectiveness)
Time frame: Baseline, 6 months, 12 months
Hospitalizations (Effectiveness)
Time frame: Duration of active 12 month study participation plus 6 months; 18 months total
Mortality (Effectiveness)
Time frame: Duration of active 12 month study participation plus 6 months; 18 months total
Missed dialysis sessions (Effectiveness)
Time frame: Duration of active 12 month study participation
Shortened dialysis sessions (Effectiveness)
Time frame: Duration of active 12 month study participation
Penetration (Implementation)
Time frame: Duration of active 12 month study participation
Fidelity (Implementation); Clinical action after PROM use; All Clinics
Time frame: Duration of active 12 month study participation
Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics
Time frame: Baseline, 6 months, and 12 months
Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics
Time frame: 6 months, and 12 months
Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics
Time frame: Duration of active 12 month study participation
Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics
Time frame: Duration of active 12 month study participation
Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics
Time frame: Baseline, 6 months, and 12 months
Acceptability (Implementation); Surveys; All Clinics
Time frame: 6 months and 12 months
Acceptability (Implementation); Interviews; All Clinics
Time frame: 6 months and 12 months
Acceptability (Implementation); Surveys; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Acceptability (Implementation); Interviews; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Appropriateness (Implementation); Surveys; All Clinics
Time frame: 6 months and 12 months
Appropriateness (Implementation); Interviews; All Clinics
Time frame: 6 months and 12 months
Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Feasibility (Implementation); Surveys; All Clinics
Time frame: 6 months and 12 months
Feasibility (Implementation); Interviews; All Clinics
Time frame: 6 months and 12 months
Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders
Time frame: Interviews will be conducted before the optimization phase and after the end of the trial.
Feasibility (Implementation); Surveys; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Feasibility (Implementation); Interviews; SMaRRT-HD Clinics
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 40889553Flythe 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Flythe, MD principal investigator
University of North Carolina, Chapel Hill
Laura Dember, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
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.