Condition category
Urological and Genital Diseases
Date applied
04/05/2007
Date assigned
22/05/2007
Last edited
22/05/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brenda Hemmelgarn

ORCID ID

Contact details

Foothills Medical Centre
1403 29th Street NW
Calgary
T2N 2T9
Canada
brenda.hemmelgarn@calgaryhealthregion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

That a targeted education intervention will eliminate barriers to living donation and improve the choice of living donation for the treatment of end-stage renal disease.

Ethics approval

Approval received from the ethics board of the University of Calgary on the 19th April 2007 (ref: E-20817).

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

End stage renal disease/living kidney donation

Intervention

Interventions:
A brief booklet will be provided upon enrolment of the study, followed by a two hour education session that occurs only once, targeting modifiable barriers to living donation.

Control:
The control group is current care (treatment as usual). Currently, treatment as usual education is received from several sources at varying points in time during their transplant workup.

All patients are followed for a total of three months to determine the outcome. Both groups also fill out a baseline questionnaire and a follow-up questionnaire at six weeks after enrolment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The intent to choose living donation as measured by a phone call to the living donor program by a donor on behalf of a participant; this will be measured at three months.

Secondary outcome measures

An improvement in knowledge and attitudes towards living donation as measured by a change in questionnaire score from baseline; this will be measured at six weeks.

Overall trial start date

01/06/2007

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are potentially eligible for a kidney transplant, including:
1. New referrals to the transplant clinic
2. Patients who are in the process of getting a transplant workup
3. Those who are active on the transplant waiting list

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

230

Participant exclusion criteria

1. Patients less than 18 years of age
2. Patients who are not fluent in the English language
3. Patients with impaired cognitive function
4. Patients who are not eligible to continue with the transplant workup process
5. Patients who have already identified a living donor

Recruitment start date

01/06/2007

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Foothills Medical Centre
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

Division of Nephrology
Department of Medicine
1403 29th Street NW
Calgary
T2N 2T9
Canada
brenda.hemmelgarn@calgaryhealthregion.ca

Sponsor type

University/education

Website

http://www.ucalgary.ca/

Funders

Funder type

University/education

Funder name

University of Calgary (Canada) - Division of Nephrology, Faculty of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alberta Kidney Disease Network (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes