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Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis (WISHED)

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interactive Health Communication Application
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring chronic kidney disease, web-based application, dialysis education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

usual care

Health Communication Application

Arm Description

Outcomes

Primary Outcome Measures

Number of patients that start home-based dialysis.
Difference between groups in proportion of patients starting home-based dialysis.

Secondary Outcome Measures

Number intended to start home-based dialysis
Difference between groups in proportion of patients intending to perform home-based dialysis
Increase in dialysis knowledge
Difference between groups in dialysis knowledge.
Increase in decision making and social support.
Difference between groups in decision conflict and sense of social support.
Mortality differences
Difference between groups in all-cause mortality.

Full Information

First Posted
July 21, 2011
Last Updated
April 18, 2016
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01403454
Brief Title
Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis
Acronym
WISHED
Official Title
Web-based IHCA for Successful Home Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, web-based application, dialysis education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Title
Health Communication Application
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Interactive Health Communication Application
Intervention Description
web-based application
Primary Outcome Measure Information:
Title
Number of patients that start home-based dialysis.
Description
Difference between groups in proportion of patients starting home-based dialysis.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number intended to start home-based dialysis
Description
Difference between groups in proportion of patients intending to perform home-based dialysis
Time Frame
1 year
Title
Increase in dialysis knowledge
Description
Difference between groups in dialysis knowledge.
Time Frame
1 year
Title
Increase in decision making and social support.
Description
Difference between groups in decision conflict and sense of social support.
Time Frame
1 year
Title
Mortality differences
Description
Difference between groups in all-cause mortality.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott K Brimble, MD
Phone
905-522-1155
Ext
33787
Email
brimbles@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Z Moreau, BSc
Phone
905-522-1155
Ext
32284
Email
cmoreau@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott K Brimble, MD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott K Brimble, Dr.
Phone
905-522-1155
Ext
33787
Email
brimbles@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Scott K Brimble, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34158965
Citation
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.
Results Reference
derived
PubMed Identifier
27307996
Citation
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.
Results Reference
derived

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Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis

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