- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01403454
Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis (WISHED)
April 18, 2016 updated by: Scott Brimble, St. Joseph's Healthcare Hamilton
Web-based IHCA for Successful Home Dialysis
This study involves Chronic Kidney Disease patients that must choose the type of dialysis therapy they ultimately wish to perform.
These patients receive education regarding dialysis types from nurses and Nephrologists at a Kidney Function Program.
The investigators have developed a web-based Interactive Health Communication Application that could provide more education and support to patients about their dialysis choices.
The investigators will compare patients that will receive usual care dialysis education versus patients that will receive additional education through this web-based application.
The investigators feel that this tool may increase the proportion of patients who start home dialysis, which offers advantages such as improvement in quality of life and deceased overall healthcare costs, over hospital hemodialysis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Scott K Brimble, MD
- Phone Number: 33787 905-522-1155
- Email: brimbles@mcmaster.ca
Study Contact Backup
- Name: Cathy Z Moreau, BSc
- Phone Number: 32284 905-522-1155
- Email: cmoreau@stjoes.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L9N 4A6
- Recruiting
- St. Joseph's Healthcare Hamilton
-
Contact:
- Scott K Brimble, Dr.
- Phone Number: 33787 905-522-1155
- Email: brimbles@mcmaster.ca
-
Principal Investigator:
- Scott K Brimble, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- enrolled in Kidney Function Program (KFP)
- previously received KFP-administered dialysis modality education
- personal access to a home computer (ie. either their own or a close friend/family member) with internet access
- most recent eGFR < or = 20mL/min/1.73m2
Exclusion Criteria:
- inability to provide informed consent
- inability to use a home computer or internet
- inability to understand English (written or spoke)
- severe visual or auditory impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: usual care
|
|
ACTIVE_COMPARATOR: Health Communication Application
|
web-based application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients that start home-based dialysis.
Time Frame: 1 year
|
Difference between groups in proportion of patients starting home-based dialysis.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number intended to start home-based dialysis
Time Frame: 1 year
|
Difference between groups in proportion of patients intending to perform home-based dialysis
|
1 year
|
Increase in dialysis knowledge
Time Frame: 1 year
|
Difference between groups in dialysis knowledge.
|
1 year
|
Increase in decision making and social support.
Time Frame: 1 year
|
Difference between groups in decision conflict and sense of social support.
|
1 year
|
Mortality differences
Time Frame: 1 year
|
Difference between groups in all-cause mortality.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott K Brimble, MD, St. Joseph's Healthcare Hamilton
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Molnar AO, Harvey A, Walsh M, Jain AK, Bosch E, Brimble KS. The WISHED Randomized Controlled Trial: Impact of an Interactive Health Communication Application on Home Dialysis Use in People With Chronic Kidney Disease. Can J Kidney Health Dis. 2021 Jun 4;8:20543581211019631. doi: 10.1177/20543581211019631. eCollection 2021.
- Harvey A, Walsh M, Jain AK, Bosch E, Moreau C, Garland J, Brimble KS. The WISHED Trial: implementation of an interactive health communication application for patients with chronic kidney disease. Can J Kidney Health Dis. 2016 Jun 15;3:29. doi: 10.1186/s40697-016-0120-y. eCollection 2016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
June 1, 2017
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (ESTIMATE)
July 27, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 19, 2016
Last Update Submitted That Met QC Criteria
April 18, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-3536
- Grant (Other Grant/Funding Number: Juan Rodés Grant (JR23/00018))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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