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Trial record 24 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Peritoneal Dialysis"

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

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ClinicalTrials.gov Identifier: NCT02670512
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Device: Telehome Monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : March 2020

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670512


Contacts
Contact: Melissa Subnath, MSc 5196858500 ext 77841 melissa.subnath@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Melissa Subnath, MSc    5196858500 ext 77841    melissa.subnath@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Arsh K Jain, MD University of Western Ontario, Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02670512     History of Changes
Other Study ID Numbers: Connect1.8
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: November 2017

Keywords provided by Lawson Health Research Institute:
End-Stage Renal Disease
Peritoneal Dialysis
Telehomecare
Telehome Monitoring

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency