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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 : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE February 1, 2016
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE June 21, 2016
Actual Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
Composite clinical outcome [ Time Frame: 1 year (plus 8 weeks for complete follow-up of technique failure) ]
The primary outcome is a composite of technique failure (switching to hemodialysis for ≥8 weeks), infections (peritonitis, exit-site, tunnel) and hospital encounters (ER visits, hospitalizations).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of clinic visits [ Time Frame: 1 year ]
    The number of clinic visits will be collected through scheduling software from the PD clinic.
  • Hospitalization Days [ Time Frame: 1 year ]
    Investigators will compare the length of hospitalizations (in days) between intervention and control group.
  • 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).
  • 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).
  • Dialysis Supplies Costs [ Time Frame: 1 year ]
    Investigators will compare the cost of supplies between the intervention and control group.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • 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.
  • 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, we 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 appointments [ Time Frame: 1 year ]
    We will examine the number of appointments that a patient has missed, which is documented through a scheduling software from the clinic.
  • Nurse Overtime hours [ Time Frame: 1 year ]
    We will examine the number of nurse over-time hours worked, specifically to 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 visits [ Time Frame: 1 year ]
    The number of clinic visits will be collected through scheduling software from the PD clinic.
  • Hospitalization Days [ Time Frame: 1 year ]
    We will compare the length of hospitalizations (in days) between intervention and control group.
  • Nursing Costs [ Time Frame: 1 year ]
    We will compare costs by applying each centre's hourly nursing cost to the number of hours nurses spent communicating with the patient (derived from our "time spent communicating" measure).
  • Healthcare Utilization Costs [ Time Frame: 1 year ]
    We 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 Costs [ Time Frame: 1 year ]
    We will compare the cost of supplies between the intervention and control group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: A Multicentre Randomized Controlled Trial
Official Title  ICMJE Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE End-Stage Renal Disease
Intervention  ICMJE Device: Telehome Monitoring
Other Name: eQ Connect™
Study Arms  ICMJE
  • 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).
    Intervention: Device: Telehome Monitoring
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 19, 2020)
467
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
500
Estimated Study Completion Date  ICMJE March 2022
Actual Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670512
Other Study ID Numbers  ICMJE Connect1.13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arsh K Jain, MD University of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP