CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients

End Stage Renal Disease Clinical Trial

— VIEWER  

Official title:

A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726526
• Other study ID #: HS25046 (B2021:066)
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Manitoba
• Contact: Claudio Rigatto, MD
• Phone: 204-631-3834
• Email: crigatto[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background: Chronic Kidney Disease (CKD) is an increasingly prevalent condition that represents a major national public health burden. The health transition from advanced CKD to the start of dialysis is a period of heightened vulnerability for many patients. Our data has demonstrated that during the 30-day period before the start of dialysis, there is a 10-fold increase in Emergency Department (ED) visits and hospitalizations related to kidney failure and its complications. Importantly, this spike occurs despite patients having frequent contact with their nephrology healthcare teams. For stable CKD patients, virtual monitoring could facilitate the communication of accurate and reliable data between patients and providers helping to avoid unnecessary ED visits and facilitate more optimal dialysis starts.

Design& Method: The VIEWER study is a national, pragmatic, multicenter randomized controlled trial across 6 Canadian sites.

(Approved sites so far: 1. Manitoba: Seven Oaks Hospital, St. Boniface hospital (SBH), and Health Sciences center (HSC), Winnipeg.

2.Ontario: Lawson Health Research Institute, London. Scarborough Corporate Medical Center, Scarborough) VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous O2 sat monitor, and wearable motion tracker. The patient-facing component of VIEWER (patient portal), is a custom application based on a mobile tablet that guides patients through a daily self-assessment routine using the connected devices. BP measurements, weight and oxygenation (as surrogates of volume status), and step counts (as a surrogate of functional status), provide semi-continuous longitudinal data on patient physical status. Additionally, patients are prompted to fill out a weekly symptom survey (Edmonton Symptom Assessment Score- revised; ESAS-r), a validated instrument of kidney failure symptoms. Patient data and ESAS scores are automatically uploaded to fully PHIA/HIPPA compliant servers where they are made available to the patients' care team through a secure, web-based provider portal. Provider notifications (flags) are generated for out-of-range values (i.e. BP, weights for volume management) and a secure messaging component allows for direct patient-provider communication. Participants will be trained to use the VIEWER platform by a member of the research team. On the provider side, two members of the care team at each site will be trained as "superusers" of the provider portal. These users will check and respond as needed daily (Monday to Friday) for flags and patient messages, and will respond or communicate as needed to the health care team as per local clinic standard operating procedures. Trends in measurements will be reviewed at multidisciplinary team rounds, which typically occur weekly. During routine clinic visits, trends in all objective and subjective measures will be available to review to inform clinical decision making. Consistent with our pragmatic design, we will not be proscriptive in how monitoring data are interpreted; rather, we ask that care teams consider this enriched data stream and incorporate that information according to their own protocols and clinical judgement.

Patients randomized to the control group will see their multidisciplinary CKD care teams as per usual care.

Follow-up visits and Focus Groups (or individual interview): Patient Reported Experience Measures (PREM) and Kidney Disease Quality of Life-Short Form (KDQOL-SF) will be measured at baseline, 3, 6, 9 and 12 months in all paticipanats. Usability, acceptability, and patient and provider perspective on the intervention will be assessed at the end of the trial using the System Usability Scale (SUS). In addition, two virtual focus groups will be conducted at the end of the study with a subset of participants and healthcare providers who used the VIEWER platform.

Statistical Methods:The primary outcome (time to first hospitalization or ED visit, censoring at dialysis or death) will be assessed using univariate Cox proportional hazards models and a Kaplan-Meier analysis with a log-rank test, as will the secondary outcomes of all-cause mortality, ED visits, hospitalization, and acute inpatient dialysis initiation. Change in overall PREM, KDQOL-SF and SUS scores will be assessed with two-sided t-test or Wilcoxon Rank Sum test as distributionally appropriate, and interpreted relative to their minimal important differences. All outcomes will be assessed at a two-sided alpha= 0.05. Subgroup analyses will be prespecified and limited to 1) eGFR greater or less than 10ml/min, 2) sex and gender (described below) 3) diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years of age

• Patient or primary caregiver can read and speak English

• Patient or patients substitute decision maker is able to provide informed consent

• Patient or primary care giver cognitively and physically capable and willing to use the VIEWER mobile application and perform self-measurements (i.e. weight, BP, etc.)

• Have stage 5 CKD (2 measurements of eGFR <15ml/min/1.73m2); eGFR will be calculated with the CKD-EPI equation.

• Followed in a multidisciplinary CKD clinic

• Have >40% chance of beginning dialysis in the next 2 years based on the Kidney Failure Risk Equation

Exclusion Criteria:

• Inability of self or caregiver assisted self-monitoring using VIEWER

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• VIEWER virtual care platform
VIEWER is a tablet based, CKD specific home telemonitoring platform developed by our team of patients and researchers that integrates data from a wireless blood pressure cuff, weigh scale, transcutaneous O2 sat monitor and wearable motion tracker via a tablet and custom app.

Locations

Country	Name	City	State
Canada	Chronic Disease Innovation Centre, Seven Oaks Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of first hospitalization or emergency department (ED) visit	It's defined as an inpatient admission to hospital or a visit to the emergency department, whatever is first". So, we will compare the time of the first hospital admission /and or ED visit between two groups.	12 months
Secondary	All-cause mortality	The mortality rate will be compared between the intervention and control group.	12 months
Secondary	Proportion of patients who have an acute inpatient initiation of dialysis.	the rate of patients who started dialysis in the intervention and control groups during 1 year of follow-up.	12 months
Secondary	Frequency of Emergency Department Visit	The average frequency of ED visit will be compared in two study groups.	12 months
Secondary	Frequency of formal clinic visits	The average frequency of formal clinic visits will be compared between two study groups	12 months
Secondary	UK Kidney PREM score (adapted to CKD)	The UK Kidney Patient Reported Experience Measure is a validated, self-reported scale that focuses on how kidney patients experience care. The UK Kidney PREM used for this trial consists of questions abstracted from the 2019 Kidney PREM. Possible scores range from 1 (strongly disagree) to 10 (strongly agree). The average total scores will be compared between intervention and control group.	baseline, 3, 6, 9 and 12 months
Secondary	Health related QOL using KQOL-SF	Kidney Disease Quality of Life- Short Form is a self-reported measure developed for individuals with kidney disease and those on dialysis. It includes 43 kidney disease targeted items, and 36 items that provide a measure of physical and mental health and 1 overall health rating item ranging from 0 (worst possible health) to 10 (best possible health).The average total scores will be compared between intervention and control groups.	baseline, 3,6,9 and 12 months
Secondary	System Usability Scale (SUS)	The System Usability Scale measures the usability of a wide range of products and services including hardware and software. It consists of a 10 item questionnaire with 5 response options ranging from 1 (strongly disagree) to 5 (strongly agree). This will be assessed via focus groups held with a subset of patients.	12 months
Secondary	Provider Perspectives towards intervention (qualitative) focus groups	Assessed via focus groups held with a subset of providers	12 months
Secondary	Patient Perspectives towards intervention (qualitative) focus groups (or individual interview)	Assessed via focus groups held with a subset of patients	12 months
Secondary	Proportion of patients greater than 80% adherence	tracked via VIEWER app	12 months