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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Foothills Medical Centre
1403 29th Street NW
Calgary
T2N 2T9
Canada
| brenda.hemmelgarn@calgaryhealthregion.ca |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 | 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 study start date | 01/06/2007 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
T2N 2T9
Canada
Sponsor information
University of Calgary (Canada)
University/education
University/education
Division of Nephrology
Department of Medicine
1403 29th Street NW
Calgary
T2N 2T9
Canada
| brenda.hemmelgarn@calgaryhealthregion.ca | |
| Website | http://www.ucalgary.ca/ |
"ROR" |
https://ror.org/03yjb2x39 |
Funders
Funder type
University/education
University of Calgary (Canada) - Division of Nephrology, Faculty of Medicine
No information available
Alberta Kidney Disease Network (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
