Clinical trial NCT02670512: Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: A Multicentre Randomized Controlled Trial
Official title: Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: End-Stage Renal Disease
Peritoneal Dialysis
Telehomecare
Telehome Monitoring
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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)

Primary outcomes:
measure: Composite clinical outcome
timeFrame: 1 year (plus 12 weeks for complete follow-up of technique failure)
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: 1 year
measure: Time spent communicating
timeFrame: 1 year
measure: Number of missed appointments
timeFrame: 1 year
measure: Nurse Overtime hours
timeFrame: 1 year
measure: Number of clinic visits
timeFrame: 1 year
measure: Hospitalization Days
timeFrame: 1 year
measure: Nursing Costs
timeFrame: 1 year
measure: Healthcare Utilization Costs
timeFrame: 1 year
measure: Dialysis Supplies Costs
timeFrame: 1 year
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital - Fraser Health Authority
state: British Columbia
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Mississauga Hospital
state: Ontario
city: Richmond Hill
country: Canada
facility: Mackenzie Health
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network - General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: St. Paul's Hospital
state: Saskatchewan
Study officials:
affiliation: University of Western Ontario, Canada
name: Arsh K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.