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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01403454
Other study ID # 11-3536
Secondary ID Grant
Status Recruiting
Phase N/A
First received July 21, 2011
Last updated April 18, 2016
Start date March 2012
Est. completion date June 2017

Study information

Verified date April 2016
Source St. Joseph's Healthcare Hamilton
Contact Scott K Brimble, MD
Phone 905-522-1155
Email brimbles@mcmaster.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Interactive Health Communication Application
web-based application

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients that start home-based dialysis. Difference between groups in proportion of patients starting home-based dialysis. 1 year No
Secondary Number intended to start home-based dialysis Difference between groups in proportion of patients intending to perform home-based dialysis 1 year No
Secondary Increase in dialysis knowledge Difference between groups in dialysis knowledge. 1 year No
Secondary Increase in decision making and social support. Difference between groups in decision conflict and sense of social support. 1 year No
Secondary Mortality differences Difference between groups in all-cause mortality. 1 year No
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