A patient-centred educational intervention to improve the choice of living kidney donation among renal transplant recipients: a randomised controlled trial

ISRCTN	ISRCTN04852451
DOI	https://doi.org/10.1186/ISRCTN04852451
Protocol serial number	N/A
Sponsor	University of Calgary (Canada)
Funders	University of Calgary (Canada) - Division of Nephrology, Faculty of Medicine, Alberta Kidney Disease Network (Canada)

Submission date: 04/05/2007
Registration date: 22/05/2007
Last edited: 23/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brenda Hemmelgarn
Scientific

Foothills Medical Centre
1403 29th Street NW
Calgary
T2N 2T9
Canada

Email	brenda.hemmelgarn@calgaryhealthregion.ca

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A patient-centred educational intervention to improve the choice of living kidney donation among renal transplant recipients: a randomised controlled trial
Study objectives	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(s)	Approval received from the ethics board of the University of Calgary on the 19th April 2007 (ref: E-20817).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	230
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Canada

Study participating centre

Foothills Medical Centre

Calgary
T2N 2T9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.