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

NCT02670512 | Completed DMC

• 1 other identifier: Connect1.13
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 11

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.

Conditions

End-Stage Renal Disease

Keywords

End-Stage Renal Disease; Peritoneal Dialysis; Telehomecare; Telehome Monitoring

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year (plus 12 weeks for complete follow-up of technique failure)

Secondary Outcomes (9)

• Health-related Quality of Life

  1 year

• Time spent communicating

  1 year

• Number of missed appointments

  1 year

• Nurse Overtime hours

  1 year

• Number of clinic visits

  1 year

Study Arms (2)

Telehome Monitoring

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Telehome Monitoring DEVICE

Also known as: eQ Connect™

Telehome Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (11)

Royal Columbian Hospital - Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

Location

Seven Oaks General Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

QEII Health Sciences Centre - Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8G 5E4, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Trillium Health Partners - Mississauga Hospital

Mississauga, Ontario, L4Z 3N6, Canada

Location

Mackenzie Health

Richmond Hill, Ontario, L4E 4L6, Canada

Location

Scarborough Health Network - General Hospital

Scarborough Village, Ontario, M1P 2V5, Canada

Location

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Related Publications (1)

• 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.

  PMID: 28486991 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arsh K Jain, MD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 1, 2016
• Study Start: June 21, 2016
• Primary Completion: March 30, 2021
• Study Completion: September 1, 2021
• Last Updated: August 19, 2022

Record last verified: 2020-11

Locations

CA (11)