search
Back to results

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

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telehome Monitoring
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End-Stage Renal Disease focused on measuring End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal Columbian Hospital - Fraser Health Authority
  • Seven Oaks General Hospital
  • QEII Health Sciences Centre - Nova Scotia Health Authority
  • St. Joseph's Healthcare Hamilton
  • Kingston General Hospital
  • London Health Sciences Centre
  • Trillium Health Partners - Mississauga Hospital
  • Mackenzie Health
  • Scarborough Health Network - General Hospital
  • Humber River Hospital
  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telehome Monitoring

Standard of Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Composite clinical outcome
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

Health-related Quality of Life
This study will utilize the Kidney Disease Quality of Life-36 (KDQOL-36) Instrument and EQ-5D to assess HRQOL.
Time spent communicating
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
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
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
The number of clinic visits will be collected through scheduling software from the PD clinic.
Hospitalization Days
Investigators will compare the length of hospitalizations (in days) between intervention and control group.
Nursing Costs
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
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
Investigators will compare the cost of supplies between the intervention and control group.

Full Information

First Posted
January 18, 2016
Last Updated
August 17, 2022
Sponsor
Lawson Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02670512
Brief Title
Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: A Multicentre Randomized Controlled Trial
Acronym
CONNECT
Official Title
Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehome Monitoring
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telehome Monitoring
Other Intervention Name(s)
eQ Connect™
Primary Outcome Measure Information:
Title
Composite clinical outcome
Description
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).
Time Frame
1 year (plus 12 weeks for complete follow-up of technique failure)
Secondary Outcome Measure Information:
Title
Health-related Quality of Life
Description
This study will utilize the Kidney Disease Quality of Life-36 (KDQOL-36) Instrument and EQ-5D to assess HRQOL.
Time Frame
1 year
Title
Time spent communicating
Description
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.
Time Frame
1 year
Title
Number of missed appointments
Description
Investigators will examine the number of appointments that a patient has missed, which is documented through a scheduling software from the clinic.
Time Frame
1 year
Title
Nurse Overtime hours
Description
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.
Time Frame
1 year
Title
Number of clinic visits
Description
The number of clinic visits will be collected through scheduling software from the PD clinic.
Time Frame
1 year
Title
Hospitalization Days
Description
Investigators will compare the length of hospitalizations (in days) between intervention and control group.
Time Frame
1 year
Title
Nursing Costs
Description
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).
Time Frame
1 year
Title
Healthcare Utilization Costs
Description
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).
Time Frame
1 year
Title
Dialysis Supplies Costs
Description
Investigators will compare the cost of supplies between the intervention and control group.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arsh K Jain, MD
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital - Fraser Health Authority
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Seven Oaks General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 3M3
Country
Canada
Facility Name
QEII Health Sciences Centre - Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Trillium Health Partners - Mississauga Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Z 3N6
Country
Canada
Facility Name
Mackenzie Health
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4E 4L6
Country
Canada
Facility Name
Scarborough Health Network - General Hospital
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
St. Paul's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 0Z9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28486991
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs