Chronic Kidney DiseaseWISHEDNCT01403454
Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis
A study testing Interactive Health Communication Application in people with Chronic Kidney Disease, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Interactive Health Communication Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jun 2017
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L9N 4A6
Scott K Brimble, Dr., 905-522-1155 ext. 33787, brimbles@mcmaster.ca
Scott K Brimble, Dr.
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Interactive Health Communication Application
- Keywords
- chronic kidney disease, web-based application, dialysis education
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Health Communication ApplicationBehavioural
web-based application
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Not described |
| Health Communication Application | Active comparator | Not described Receives: Behavioral: Interactive Health Communication Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that start home-based dialysis.
Difference between groups in proportion of patients starting home-based dialysis.
Measured: 1 year
Secondary outcomes (4)
Number intended to start home-based dialysis
Difference between groups in proportion of patients intending to perform home-based dialysis
Measured: 1 year
Increase in dialysis knowledge
Difference between groups in dialysis knowledge.
Measured: 1 year
Increase in decision making and social support.
Difference between groups in decision conflict and sense of social support.
Measured: 1 year
Mortality differences
Difference between groups in all-cause mortality.
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 posted27 Jul 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Scott Brimble, St. Joseph's Healthcare Hamilton
- Investigators
- Scott K Brimble, MD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403454
- Sponsor's protocol ID
- 11-3536
- Other IDs
- Grant
- Acronym
- WISHED
- Status last verified
- Apr 2016
- First submitted
- 21 Jul 2011
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34158965Harvey 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.
PubMed 27307996
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based IHCA for Successful Home Dialysis
- ClinicalTrials.gov ID
- NCT01403454
- Acronym / sponsor ID
- WISHED / 11-3536
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, web-based application, dialysis education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Mar 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 Jul 2011 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | – |
| Health Communication Application | Active comparator | Behavioral: Interactive Health Communication Application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Interactive Health Communication Applicationweb-based application | Behavioural | Health Communication Application |
Primary outcome
Number of patients that start home-based dialysis.
Time frame: 1 year
Difference between groups in proportion of patients starting home-based dialysis.
4 secondary outcomes
Number intended to start home-based dialysis
Time frame: 1 year
Increase in dialysis knowledge
Time frame: 1 year
Increase in decision making and social support.
Time frame: 1 year
Mortality differences
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Derived from this study: PubMed 34158965Molnar 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.
- Derived from this study: PubMed 27307996Harvey 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.
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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.
Scott K Brimble, MD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Health Communication Application in people with Chronic Kidney Disease, run by St. Joseph's Healthcare Hamilton at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott K Brimble, MD (905-522-1155 ext. 33787, brimbles@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that start home-based dialysis. (time frame: 1 year). 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 NCT01403454, which also lists 2 linked publications.
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 Apr 2016.