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
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease||Device: Telehome Monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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.
- 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).
- 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.
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
|Contact: Melissa Subnath, MSc||5196858500 ext firstname.lastname@example.org|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Melissa Subnath, MSc 5196858500 ext 77841 email@example.com|
|Principal Investigator:||Arsh K Jain, MD||University of Western Ontario, Canada|