[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05738330":3,"trial-entities:NCT05738330":197,"trial-summary:NCT05738330":201},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":150,"minimum_age":151,"maximum_age":17,"healthy_volunteers":152,"eligibility_criteria":153,"std_ages":164,"locations":167,"central_contacts":183,"overall_officials":184,"references":191,"see_also_links":196},"NCT05738330","852661","Symptom Monitoring in Hemodialysis","Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis","RECRUITING","2027-09","2025-11","2025-11-24","2023-06-24","University of Pennsylvania","OTHER",true,"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.",null,[19],"End Stage Kidney Disease",[21,22,23,24,25,26],"End stage kidney disease","Kidney","Hemodialysis","Dialysis","Symptom monitoring","Electronic Patient-Reported Outcome Measure (ePROM)","INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},2400,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"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.",[40],"SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)",{"type":36,"name":42,"description":43,"armGroupLabels":44},"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.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"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).\n\nParticipants 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",[51,54,57,60,63,66,69,72,76,79,83,86,89,92,96,100,103,106,109,113,116,119,122,125,128,131,134,137,140,144,147],{"measure":52,"description":53,"timeFrame":49},"Health-related quality of life (Effectiveness)","EuroQOL 5D-5L (EQ-5D-5L)\n\nParticipants 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.",{"measure":55,"description":56,"timeFrame":49},"Post-dialysis recovery time (Effectiveness)","Recovery time question",{"measure":58,"description":59,"timeFrame":49},"Fatigue (Effectiveness)","PROMIS Fatigue SF 6a\n\nFatigue 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.",{"measure":61,"description":62,"timeFrame":49},"Pain interference (Effectiveness)","Brief Pain Inventory (BPI)- Interference\n\nParticipants 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.",{"measure":64,"description":65,"timeFrame":49},"Anxiety (Effectiveness)","Generalized Anxiety Disorder (GAD)-7\n\nParticipants 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.",{"measure":67,"description":68,"timeFrame":49},"Depression (Effectiveness)","Patient Health Questionnaire (PHQ)-8\n\nParticipants 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.",{"measure":70,"description":71,"timeFrame":49},"Healthcare Engagement (Effectiveness)","Healthcare Engagement - Short Form 8a (PHE-8a)\n\nParticipants 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.",{"measure":73,"description":74,"timeFrame":75},"Hospitalizations (Effectiveness)","Hospitalization rate","Duration of active 12 month study participation plus 6 months; 18 months total",{"measure":77,"description":78,"timeFrame":75},"Mortality (Effectiveness)","Mortality rate",{"measure":80,"description":81,"timeFrame":82},"Missed dialysis sessions (Effectiveness)","The number of missed dialysis sessions during participation in the the trial.","Duration of active 12 month study participation",{"measure":84,"description":85,"timeFrame":82},"Shortened dialysis sessions (Effectiveness)","The number of shortened dialysis sessions during participation in the the trial.",{"measure":87,"description":88,"timeFrame":82},"Penetration (Implementation)","SMaRRT-HD completion rates collected from the SMaRRT-HD system and KDQOL™-36 completion rates collected from the dialysis medical record",{"measure":90,"description":91,"timeFrame":82},"Fidelity (Implementation); Clinical action after PROM use; All Clinics","Evidence in the dialysis medical record of clinician action in response to a reported symptom.",{"measure":93,"description":94,"timeFrame":95},"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",{"measure":97,"description":98,"timeFrame":99},"Fidelity (Implementation); Patient\u002Fclinician-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",{"measure":101,"description":102,"timeFrame":82},"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.",{"measure":104,"description":105,"timeFrame":82},"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.",{"measure":107,"description":108,"timeFrame":95},"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.",{"measure":110,"description":111,"timeFrame":112},"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",{"measure":114,"description":115,"timeFrame":112},"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.",{"measure":117,"description":118,"timeFrame":112},"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.",{"measure":120,"description":121,"timeFrame":112},"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.",{"measure":123,"description":124,"timeFrame":112},"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.",{"measure":126,"description":127,"timeFrame":112},"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.",{"measure":129,"description":130,"timeFrame":112},"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.",{"measure":132,"description":133,"timeFrame":112},"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.",{"measure":135,"description":136,"timeFrame":112},"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.",{"measure":138,"description":139,"timeFrame":112},"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.",{"measure":141,"description":142,"timeFrame":143},"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.",{"measure":145,"description":146,"timeFrame":112},"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.",{"measure":148,"description":149,"timeFrame":112},"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.","ALL","18 Years",false,{"inclusion":154,"exclusion":158,"raw_text":163},[155,156,157],"Age ≥ 18 years","Treatment with hemodialysis at a participating dialysis clinic","English or Spanish speaking",[159,160,161,162],"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","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Treatment with hemodialysis at a participating dialysis clinic\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Not willing to report their symptoms using the SMaRRT-HD platform\n* Not willing to share clinically acquired data with the research team\n* Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)\n* Incarceration",[165,166],"ADULT","OLDER_ADULT",[168],{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":173,"contacts":174,"geoPoint":180},"Fresenius Medical Care","Waltham","Massachusetts","02451","United States",[175],{"name":176,"role":177,"phone":178,"email":179},"Cassandra Bowman, MHA","CONTACT","919-445-6790","Cassandra_Bowman@unc.edu",{"lat":181,"lon":182},42.37649,-71.23561,[],[185,189],{"name":186,"affiliation":187,"role":188},"Jennifer Flythe, MD","University of North Carolina, Chapel Hill","PRINCIPAL_INVESTIGATOR",{"name":190,"affiliation":13,"role":188},"Laura Dember, MD",[192],{"pmid":193,"type":194,"citation":195},"40889553","DERIVED","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\u002Fj.cct.2025.108058. Epub 2025 Aug 30.",[],{"nct_id":4,"conditions":198,"biomarkers":200},[199],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":15,"summary":202,"prompt_version":212},{"design":203,"status":204,"heading":205,"summary":206,"follow_up":207,"word_count":208,"commitments":209,"compensation":210,"drugs_mentioned":211},"This is an interventional study that will enroll approximately 2400 participants. It is a cluster randomized trial, meaning groups of dialysis clinics will be assigned to either use the SMaRRT-HD system or continue with usual care.","completed","Symptom Monitoring in Hemodialysis (SMaRRT-HD) Trial","This study, called SMaRRT-HD, is looking at whether regularly tracking symptoms and having clinicians follow up can improve care for people with end-stage kidney disease who are on hemodialysis. You might be able to join if you are 18 or older, receive hemodialysis at a participating clinic, and speak English or Spanish. The study is comparing two approaches: one group of clinics will use the SMaRRT-HD system to collect your symptoms and help your care team respond, while the other group will continue with usual care. The main goal is to see if using SMaRRT-HD reduces how severe your dialysis-related symptoms are over 12 months. This study is currently recruiting about 2400 patients across the US.","Your symptom severity will be measured at the start of the study, at 6 months, and at 12 months.",116,"If your clinic is assigned to the SMaRRT-HD group, you would report your symptoms using the SMaRRT-HD platform. Clinics in the SMaRRT-HD group will adopt its use for 12 months.","Not stated in the trial record.",[42],"v2"]