End-Stage Renal DiseaseCONNECTNCT02670512
Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis: A Multicentre Randomized Controlled Trial
A study testing Telehome Monitoring in people with End-Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Telehome Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 11 sitesCanada
- Study dates
- 21 Jun 2016to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
QEII Health Sciences Centre - Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8G 5E4
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5W9
Trillium Health Partners - Mississauga Hospital
Mississauga, Ontario, L4Z 3N6
Royal Columbian Hospital - Fraser Health Authority
New Westminster, British Columbia, V3L 3W7
Mackenzie Health
Richmond Hill, Ontario, L4E 4L6
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, M1P 2V5
Humber River Hospital
Toronto, Ontario, M3M 0B2
Seven Oaks General Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
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
- Being tested
- Telehome Monitoring
- Keywords
- End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehome MonitoringDevice
Also called eQ Connect™
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year (plus 12 weeks for complete follow-up of technique failure)
Secondary outcomes (9)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Number of clinic visits
The number of clinic visits will be collected through scheduling software from the PD clinic.
Measured: 1 year
Hospitalization Days
Investigators will compare the length of hospitalizations (in days) between intervention and control group.
Measured: 1 year
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).
Measured: 1 year
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).
Measured: 1 year
Dialysis Supplies Costs
Investigators will compare the cost of supplies between the intervention and control group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start21 Jun 2016
- Primary completion30 Mar 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arsh K Jain, MD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670512
- Sponsor's protocol ID
- Connect1.13
- Acronym
- CONNECT
- Status last verified
- Nov 2020
- First submitted
- 18 Jan 2016
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28486991
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02670512
- Acronym / sponsor ID
- CONNECT / Connect1.13
- Conditions
- End-Stage Renal Disease
- Keywords
- End-Stage Renal Disease, Peritoneal Dialysis, Telehomecare, Telehome Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehome Monitoring | Experimental | Device: Telehome MonitoringPatients 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehome MonitoringAlso: eQ Connect™ | Device | Telehome Monitoring |
Primary outcome
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).
9 secondary outcomes
Health-related Quality of Life
Time frame: 1 year
Time spent communicating
Time frame: 1 year
Number of missed appointments
Time frame: 1 year
Nurse Overtime hours
Time frame: 1 year
Number of clinic visits
Time frame: 1 year
Hospitalization Days
Time frame: 1 year
Nursing Costs
Time frame: 1 year
Healthcare Utilization Costs
Time frame: 1 year
Dialysis Supplies Costs
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 28486991Jeffs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arsh K Jain, MD principal investigator
University of Western Ontario, Canada
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehome Monitoring in people with End-Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical outcome (time frame: 1 year (plus 12 weeks for complete follow-up of technique failure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.