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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670512
Acronym
CONNECT
Enrollment
467
Registered
2016-02-01
Start date
2016-06-21
Completion date
2021-09-01
Last updated
2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring

Brief 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.

Interventions

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Composite clinical outcome1 year (plus 12 weeks for complete follow-up of technique failure)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).

Secondary

MeasureTime frameDescription
Time spent communicating1 yearThis 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.
Number of missed appointments1 yearInvestigators will examine the number of appointments that a patient has missed, which is documented through a scheduling software from the clinic.
Nurse Overtime hours1 yearInvestigators 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.
Number of clinic visits1 yearThe number of clinic visits will be collected through scheduling software from the PD clinic.
Health-related Quality of Life1 yearThis study will utilize the Kidney Disease Quality of Life-36 (KDQOL-36) Instrument and EQ-5D to assess HRQOL.
Nursing Costs1 yearInvestigators 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).
Healthcare Utilization Costs1 yearInvestigators 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).
Dialysis Supplies Costs1 yearInvestigators will compare the cost of supplies between the intervention and control group.
Hospitalization Days1 yearInvestigators will compare the length of hospitalizations (in days) between intervention and control group.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026