Symptom Monitoring in Hemodialysis
ConditionEnd Stage Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Treatment with hemodialysis at a participating dialysis clinic
English or Spanish speaking
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
BehavioralDialysis 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 Care
BehavioralDialysis 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.
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)Active comparator 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 6 months, 12 monthsSecondary outcomes
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.
Time frame
Baseline, 6 months, 12 months2
Post-dialysis recovery time (Effectiveness)
Recovery time question
Time frame
Baseline, 6 months, 12 months3
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.
Time frame
Baseline, 6 months, 12 months4
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.
Time frame
Baseline, 6 months, 12 monthsOther outcomes
1
Quality of patient-clinician communication (Effectiveness)
In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS)- Communication and Caring Domain
Time frame
Baseline, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
University of North Carolina, Chapel Hill
Collaborator
Duke University
Collaborator
University of New Mexico
Collaborator
Fresenius Medical Care North America
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov