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

NCT ID: NCT02670512

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-21

Study Completion Date

2021-09-01

Brief Summary

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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

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Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Telehome Monitoring

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telehome Monitoring

Intervention Type DEVICE

Other Intervention Names

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eQ Connect™

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arsh K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

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Royal Columbian Hospital - Fraser Health Authority

New Westminster, British Columbia, Canada

Site Status

Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

Site Status

QEII Health Sciences Centre - Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Trillium Health Partners - Mississauga Hospital

Mississauga, Ontario, Canada

Site Status

Mackenzie Health

Richmond Hill, Ontario, Canada

Site Status

Scarborough Health Network - General Hospital

Scarborough Village, Ontario, Canada

Site Status

Humber River Hospital

Toronto, Ontario, Canada

Site Status

St. Paul's Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 28486991 (View on PubMed)

Other Identifiers

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Connect1.13

Identifier Type: -

Identifier Source: org_study_id

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