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Completed

NCT Number: NCT02670512

Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: 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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital - Fraser Health Authority, New Westminster, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telehome Monitoring

Device

Other names: eQ Connect™

Primary outcomes

  1. Composite clinical outcome

    Time frame: 1 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 outcomes

  1. Health-related Quality of Life

    Time frame: 1 year

    This study will utilize the Kidney Disease Quality of Life-36 (KDQOL-36) Instrument and EQ-5D to assess HRQOL.

  2. Time spent communicating

    Time frame: 1 year

    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.

  3. Number of missed appointments

    Time frame: 1 year

    Investigators will examine the number of appointments that a patient has missed, which is documented through a scheduling software from the clinic.

  4. Nurse Overtime hours

    Time frame: 1 year

    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.

  5. Number of clinic visits

    Time frame: 1 year

    The number of clinic visits will be collected through scheduling software from the PD clinic.

  6. Hospitalization Days

    Time frame: 1 year

    Investigators will compare the length of hospitalizations (in days) between intervention and control group.

  7. Nursing Costs

    Time frame: 1 year

    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).

  8. Healthcare Utilization Costs

    Time frame: 1 year

    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).

  9. Dialysis Supplies Costs

    Time frame: 1 year

    Investigators will compare the cost of supplies between the intervention and control group.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: CONNECT

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2016
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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