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

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

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.

Study Overview

• Status: Completed
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Device: Telehome Monitoring

• Study Type: Interventional
• Enrollment (Actual): 467
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital - Fraser Health Authority
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
      • Seven Oaks General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QEII Health Sciences Centre - Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8G 5E4
      • St. Joseph's Healthcare Hamilton
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Mississauga, Ontario, Canada, L4Z 3N6
      • Trillium Health Partners - Mississauga Hospital
    • Richmond Hill, Ontario, Canada, L4E 4L6
      • Mackenzie Health
    • Scarborough, Ontario, Canada, M1P 2V5
      • Scarborough Health Network - General Hospital
    • Toronto, Ontario, Canada, M3M 0B2
      • Humber River Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7M 0Z9
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehome Monitoring; 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; Other Names: eQ Connect™
No Intervention: Standard of Care; 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?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Arsh K Jain, MD, University of Western Ontario, Canada

Publications and helpful links

General Publications

• Jeffs L, Jain AK, Man RH, Onabajo N, Desveaux L, Shaw J, Hensel J, Agarwal P, Saragosa M, Jamieson T, Wong I, Maione M, Bhatia RS. Exploring the utility and scalability of a telehomecare intervention for patients with chronic kidney disease undergoing peritoneal dialysis-a study protocol. BMC Nephrol. 2017 May 10;18(1):155. doi: 10.1186/s12882-017-0557-y.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2016
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; End-Stage Renal Disease; Telehomecare; Telehome Monitoring
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: Connect1.13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No