Clinical trial NCT05726526: CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
Official title: A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 5
End Stage Renal Disease
Keywords: telemonitoring
chronic kidney disease
suboptimal dialysis initiation
digital health
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly allocated to the intervention group (usual care + the VIEWER virtual care platform) or the control group (usual care).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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 5 Canadian sites from two provinces including:

1. Seven Oaks General Hospital (SOGH), Winnipeg, Manitoba.
2. St. Boniface hospital (SBH), Winnipeg, Manitoba.
3. Health Sciences center (HSC), Winnipeg, Manitoba.
4. Health Sciences Center, London, Ontario.
5. Scarborough Health Network (SHN), Scarborough, Ontario.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of first hospitalization or emergency department (ED) visit
timeFrame: 12 months or until dialysis initiation
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months or until dialysis initiation
measure: Proportion of patients who have an acute inpatient initiation of dialysis.
timeFrame: 12 months or until dialysis initiation
measure: Frequency of Emergency Department Visit
timeFrame: 12 months or until dialysis initiation
measure: Frequency of formal clinic visits
timeFrame: 12 months or until dialysis initiation
measure: UK Kidney PREM score (adapted to CKD)
timeFrame: baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation)
measure: Health related QOL using KQOL-SF
timeFrame: baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)
measure: System Usability Scale (SUS)
timeFrame: 12 months ( or at the time of dialysis initiation)
measure: Provider Perspectives towards intervention (qualitative) focus groups
timeFrame: 12 months (or end of study)
measure: Patient Perspectives towards intervention (qualitative) focus groups (or individual interview)
timeFrame: 12 months (or end of study)
measure: Proportion of patients greater than 80% adherence
timeFrame: 12 months (or end of study)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Chronic Disease Innovation Centre, Seven Oaks Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network - General Hospital
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Claudio Rigatto, MD
role: PRINCIPAL_INVESTIGATOR
References: