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

End-Stage Renal Disease Clinical Trial

— CONNECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670512
• Other study ID #: Connect1.13
• Status: Completed
• Phase: N/A
• Start date: June 21, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: September 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to provide informed consent

2. Patient or primary care giver able to read and speak English

3. Over 18 years of age

4. Patient on PD (APD/CAPD) for at least 3 months

5. 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:

1. Scheduled kidney transplant within 1 year (identified, processed and medically worked out their donor)

2. Life expectancy <1 year (estimated by physician)

3. In long-term care facility

4. 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

5. Participating in another interventional trial that could influence the intervention or outcome of this trial

6. Was in another interventional trial that could influence the intervention or outcome of this trial, =4 weeks prior to recruitment

7. Patients on hybrid dialysis (those on both peritoneal dialysis and hemodialysis)

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Telehome Monitoring

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre - Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Trillium Health Partners - Mississauga Hospital	Mississauga	Ontario
Canada	Royal Columbian Hospital - Fraser Health Authority	New Westminster	British Columbia
Canada	Mackenzie Health	Richmond Hill	Ontario
Canada	St. Paul's Hospital	Saskatoon	Saskatchewan
Canada	Scarborough Health Network - General Hospital	Scarborough	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	Seven Oaks General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of clinic visits	The number of clinic visits will be collected through scheduling software from the PD clinic.	1 year
Secondary	Hospitalization Days	Investigators will compare the length of hospitalizations (in days) between intervention and control group.	1 year
Secondary	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
Secondary	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
Secondary	Dialysis Supplies Costs	Investigators will compare the cost of supplies between the intervention and control group.	1 year