Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: A Multicentre Randomized Controlled Trial

Study Overview
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Brief Summary
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Compared to hemodialysis, patients on peritoneal dialysis live longer and healthier, have a higher quality of life and cost approximately $40,000 less to the healthcare system per patient per year. However, only 18% of dialysis patients in Canada currently use peritoneal dialysis because patients often feel isolated from the healthcare team and lack the confidence to manage treatments by themselves. This study will assess a telehome monitoring system (eQ Connect™), allowing for up-to-date data transmission and digital interaction between the patients at home and their healthcare team. From the patients' perspective, this technology is an easier way to communicate with their healthcare providers, track their treatment and supplies, and receive training and support. From the providers' perspective, eQ Connect™ delivers up-to-date patient data and provides an efficient way to keep track of the patients' progress. This intervention has the potential to improve the patients' clinical outcomes, quality of life, reduce the costs of dialysis to the healthcare system and ultimately empower patients to start and stay on peritoneal dialysis.

Official Title
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Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Device: Telehome Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Patient or primary care giver able to read and speak English Over 18 years of age Patient on PD (APD/CAPD) for at least 3 months Patient or primary care giver cognitively and physically capable and willing to interact with a tablet computer and perform self-measurements (e.g. taking weight) Exclusion Criteria: Scheduled kidney transplant within 1 year (identified, processed and medically worked out their donor) Life expectancy <1 year (estimated by physician) In long-term care facility Deemed unable to comply with the telehome monitoring support system (e.g. due to vision problems, literacy, lack of manual dexterity to accurately interact with the tablet, or decreased cognitive function such as memory loss) by physician Participating in another interventional trial that could influence the intervention or outcome of this trial Was in another interventional trial that could influence the intervention or outcome of this trial, ≤4 weeks prior to recruitment Patients on hybrid dialysis (those on both peritoneal dialysis and hemodialysis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehome Monitoring<br>Patients in this arm will use the telehome monitoring device (a mobile tablet) to support them with their peritoneal dialysis (communication, treatment tracking, supply tracking, appointment reminders, educational content). | Device: Telehome Monitoring<br> <br> * Other names: eQ Connect™;|
| No Intervention: Standard of Care<br>Patients in this arm use the standard of care for peritoneal dialysis, which is simple telephone communication and using pen and paper log to track their treatments and supplies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical outcome | The primary outcome is a composite of technique failure (switching to hemodialysis for ≥12 weeks), infections (peritonitis, exit-site, tunnel) and hospital encounters (ER visits, hospitalizations). | 1 year (plus 12 weeks for complete follow-up of technique failure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | This study will utilize the Kidney Disease Quality of Life-36 (KDQOL-36) Instrument and EQ-5D to assess HRQOL. | 1 year | 
| Time spent communicating | This measure captures the time a patient spends communicating with the healthcare team. This is measured through automated telephone logs and paper telephone logs that are documented by nurses. For patients in the intervention arm, investigators will also obtain the duration of video calls and amount of time spent on the message screen (number of minutes). We will also capture the number of messages that are sent on the telehome monitoring device. | 1 year | 
| Number of missed appointments | Investigators will examine the number of appointments that a patient has missed, which is documented through a scheduling software from the clinic. | 1 year | 
| Nurse Overtime hours | Investigators deliver care for the patients. The number of hours worked over-time are documented in a telephone log manually, which includes the patient's name, reason for call and call duration. | 1 year | 
| Number of clinic visits | The number of clinic visits will be collected through scheduling software from the PD clinic. | 1 year | 
| Hospitalization Days | Investigators will compare the length of hospitalizations (in days) between intervention and control group. | 1 year | 
| Nursing Costs | Investigators will compare costs by applying each centre's hourly nursing cost to the number of hours nurses spent communicating with the patient (derived from time spent communicating measure). | 1 year | 
| Healthcare Utilization Costs | Investigators will use the Case Costing Macro at ICES to compare the health utilization costs between two groups, including costs from emergency room visits and hospitalizations. (This is only applicable to the Ontario Centres). | 1 year | 
| Dialysis Supplies Costs | Investigators will compare the cost of supplies between the intervention and control group. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring