Telemonitoring Platform for Chronic Kidney Disease
(VIEWER Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Disqualifiers: Inability of self-monitoring
No Placebo Group
Trial Summary
What is the purpose of this trial?The main purpose of this trial is to determine whether the addition of the VIEWER virtual care platform to usual care will lead to a reduction in composite emergency department (ED) visits and/or hospitalizations/or increase the perceived safety of virtual care among patients and providers.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the VIEWER virtual care platform treatment for chronic kidney disease?
Research on remote patient management (RPM) for home dialysis shows that telehealth platforms can improve patient outcomes by enabling real-time monitoring and communication with healthcare providers. This approach helps detect early issues, ensures treatment compliance, and reduces patient anxiety, which could be beneficial for managing chronic kidney disease.
12345Is the telemonitoring platform for chronic kidney disease safe for humans?
The research suggests that telemedicine, including platforms like the VIEWER virtual care platform, can help improve patient safety by allowing CKD patients to communicate safety-related issues to their healthcare providers. However, some patients may face challenges using these technologies, which could impact their effectiveness in preventing safety events.
678910How does the telemonitoring platform for chronic kidney disease differ from other treatments?
The telemonitoring platform for chronic kidney disease is unique because it allows patients to monitor their health from home and communicate with healthcare professionals remotely. This approach can improve patient adherence to treatment plans and enable early detection of health issues, potentially preventing hospitalizations.
111121314Eligibility Criteria
This trial is for adults over 18 with stage 5 chronic kidney disease (CKD), who are likely to need dialysis within two years. Participants or their caregivers must be able to read and speak English, give informed consent, and use the VIEWER app for self-monitoring tasks like measuring weight and blood pressure.Inclusion Criteria
My kidney function is very low, with an eGFR under 15.
I am being treated at a specialized clinic for chronic kidney disease.
Patient or primary caregiver can read and speak English
+4 more
Exclusion Criteria
You can't use VIEWER to monitor yourself, even with help from someone else.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants use the VIEWER platform for daily self-assessment and weekly symptom surveys, in addition to usual care
12 months or until dialysis initiation
Daily self-assessment via app, weekly symptom survey
Control
Participants receive usual care either virtually or in person, depending on COVID-19 restrictions
12 months or until dialysis initiation
Regular clinic visits as per usual care
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months or until dialysis initiation
Follow-up visits at baseline, 3, 6, 9, and 12 months
Participant Groups
The study tests if adding the VIEWER virtual care platform to regular treatment helps reduce emergency visits, hospital stays, or improves feelings of safety with virtual care among high-risk CKD patients compared to usual care without this technology.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Participants randomized to the intervention group will be provided with a wireless BP cuff, weight scale, transcutaneous O2 sat monitor, wearable motion tracker and mobile tablet with the VIEWER application. Patients will be trained to use the VIEWER platform either virtually or in person. Patients will be guided through a daily self-assessment routine via the app (BP, weight, O2 saturation, step count upload) and weekly ESAS-r survey. Participants will use the VIEWER platform for 12 months ( or until dialysis initiation) in addition to receiving usual care. Additionally, participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation), and the System Usability Scale (SUS) at 12 months.
Group II: Control GroupActive Control1 Intervention
Participants randomized to the control group will continue to receive usual care either virtually via telephone or video call or in person depending on COVID-19 restrictions in place. Participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
Scarborough Health Network - General HospitalScarborough, Canada
Chronic Disease Innovation Centre, Seven Oaks HospitalWinnipeg, Canada
Loading ...
Who Is Running the Clinical Trial?
University of ManitobaLead Sponsor
References
Remote Patient Management in Peritoneal Dialysis: An Answer to an Unmet Clinical Need. [2021]The burden of chronic kidney disease is increasing globally. Novel methods for the management of end-stage kidney disease at home have been available for several years, however uptake of home peritoneal dialysis (PD) has been suboptimal for a variety of reasons. Non-adherence is an important factor that determines the outcomes of PD; patients on home dialysis are subject to feeling isolated and are anxious to lack of routine clinical oversight. When patients feel disconnected from their health care professionals, their compliance to medical advice drops and their confidence in self-care comes down. Remote patient management (RPM) has the potential to improve outcomes in PD through telehealth platforms that facilitate virtual clinical presence, enable patient-generated clinical documentation and feedback mechanism, and promote self-monitoring. Bi-directional communications between patients and clinicians provide an enabling environment for autonomy while being clinically monitored through a co-presence, resulting in collaborative care that could alleviate the anxiety of the patients about not being under the direct care of a physician. RPM enables the clinicians to closely monitor and detect early issues, provide feedback in real-time, and initiate early interventions such as prescription modifications and contextual clinical decision support. As the computational capabilities improve and clinical data are collated, machine learning and artificial intelligence algorithms would help detect patterns and predict impending complications such as fluid overload, heart failure or peritonitis, thereby allowing early detection and interventions to avoid hospitalizations. The technical framework and essential features for a RPM system in PD is outlined in this chapter.
Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. [2022]The use of routine remote follow-up of patients with chronic kidney disease (CKD) is increasing exponentially. It has been suggested that online electronic patient-reported outcome measures (ePROMs) could be used in parallel, to facilitate real-time symptom monitoring aimed at improving outcomes. We tested the feasibility of this approach in a pilot trial of ePROM symptom monitoring versus usual care in patients with advanced CKD not on dialysis.
[Impact of remote monitoring in home dialysis: 5-year observation results]. [2023]Dialysis (hemodialysis and peritoneal dialysis) is one of the main therapeutic alternatives for patients with end-stage renal disease. It can be provided in different settings, including the home setting. Published literature shows that home dialysis improves both survival and quality of life, while producing economic advantages. However, there are also significant barriers. Home dialysis patients often report "abandonment issues" by healthcare personnel. This work aimed at assessing the efficiency of the Doctor Plus® Nephro telemedicine system (adopted in the Nephrology Center of the P.O. G.B. Grassi di Roma-ASL Roma 3) in monitoring patient health status and improving the quality of care. From 2017 to 2022, N=26 patients were included in the analysis (mean duration of observation: 2.3 years). The analysis showed that the program was able to promptly identify possible anomalies of the vital parameters and activate a series of interventions aimed at normalizing the altered profile. During the study period, the system issued N=41,563 alerts (N=1.87 alerts per patient/day), of which N=16,325 (39.3%) were clinical and N=25,238 (60.7%) were missed measurements. These warnings ensured stabilization of the parameters, with clear benefits on patients' quality of life. A trend of improvement was reported by patients, regarding their perception of the health state (EQ-5D questionnaire; +11.1 points on the VAS scale), the number of hospital admissions (-0.43 accesses/patient in 4 months), and of working days lost (-3.6 days lost in 4 months). Therefore, Doctor Plus® Nephro represents a useful and efficient tool for home dialysis patients' management.
Health Economic Implications of Remote Patient Management. [2021]Remote patient management and telemedicine have great potential to improve the care of patients with end-stage kidney disease undergoing peritoneal dialysis (PD). Since PD is performed by patients and their families, typically in the home setting away from expert clinical support, remote monitoring of treatments may detect early problems, ensure compliance, and give both providers and patients a sense of reassurance that complications can be minimized and detected. These advantages may translate into improved outcomes and increased uptake of home dialysis therapies. Estimates of the financial impact of these potential improvements in care can be performed and are discussed in this chapter. These economic impacts are potentially significant and further the case for carefully designed clinical trials to assess the impact of these new technologies.
Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. [2021]Kidney transplant outcomes are broadly associated with transplant recipients' capacity in following a complex and continuous self-management regimen. Health information technology has the potential to empower patients. This systematic review aimed to determine the impacts of IT-based interventions for self-management in kidney transplant recipients.
Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]CKD patients have several features conferring on them a high risk of adverse safety events, which are defined as incidents with unintended harm related to processes of care or medications. These characteristics include impaired kidney function, polypharmacy, and frequent health system encounters. The consequences of such events in CKD can include new or prolonged hospitalization, accelerated kidney function loss, acute kidney injury, ESRD, and death. Health information technology administered via telemedicine presents opportunities for CKD patients to remotely communicate safety-related findings to providers for the purpose of improving their care. However, many CKD patients have limitations that hinder their use of telemedicine and access to the broad capabilities of health information technology. In this review, we summarize previous assessments of the pre-dialysis CKD populations' proficiency in using telemedicine modalities and describe the use of interactive voice-response system to gauge the safety phenotype of the CKD patient. We discuss the potential for expanded interactive voice-response system use in CKD to address the safety threats inherent to this population.
Use, Perceived Usability, and Barriers to Implementation of a Patient Safety Dashboard Integrated within a Vendor EHR. [2021]Preventable adverse events continue to be a threat to hospitalized patients. Clinical decision support in the form of dashboards may improve compliance with evidence-based safety practices. However, limited research describes providers' experiences with dashboards integrated into vendor electronic health record (EHR) systems.
Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]Patients with CKD are at risk for adverse drug reactions, but effective community-based preventive programs remain elusive. In this study, we compared the effectiveness of two digital applications designed to improve outpatient medication safety.
AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. [2021]Reviewing the adverse event data collected in clinical trials is a lengthy and tedious process when these data are presented in the form of tables, data listings, and static graphs. Thus, to enable anyone interested in exploring adverse event data efficiently and relatively independently, we developed AdEPro, a compact, powerful, and easy-to-use interactive app.
Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study. [2020]Home dialysis patients may be at an increased risk of adverse events after transitional states. The home dialysis virtual ward (HDVW) trial was conducted in Canadian dialysis centers and aimed to evaluate potential care gaps and patient satisfaction during the HDVW.
Telemonitoring is acceptable amongst community dwelling older Australians with chronic conditions. [2019]Telemonitoring is an innovative model of care being implemented to address thegrowing burden of chronic and complex disease.
[Will telemonitoring be adopted by patients with chronic heart failure?]. [2018]Remote Patient Management for chronic heart failure (CHF) is gaining increasing importance in health care. Telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre. The adherence of this action by the patient can be considered as a measure for RPM adoption.
Usage of a Web-Based Platform for Home Care Providers in the Pandemic Context. [2021]The paper presents the usage of a platform for home care providers that integrates telemonitoring functionalities in the context of the recent COVID-19 pandemic.
Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. [2022]Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study.