Health Related Quality of Life in ESRD Patients Older Than 65 Years (QUESTION65)
This study is currently recruiting participants.
Verified January 2013 by Sykehuset Telemark
Sponsor:
Sykehuset Telemark
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Kristian Heldal, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT01760733
First received: December 17, 2012
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
Kidney transplantation has been shown to provide improved survival even in patients older than 70 years of age. The purpose of the study is to determine whether kidney transplantation provides any improvement of health related quality of life (HRQOL) in patients over the age of 65 years. HRQOL wil be monitored using the Kidney Disease and Quality of Life (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the Norwegian transplant wait list and followed every 6 months until 1 year after transplantation. Thereafter a new form will be completed after 3 years and 5 years.
| Condition |
|---|
|
Quality of Life End Stage Renal Disease End Stage Renal Failure on Dialysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Health Related Quality of Life in ESRD Patients Older Than 65 Years |
Resource links provided by NLM:
Further study details as provided by Sykehuset Telemark:
Primary Outcome Measures:
- Health related quality of life [ Time Frame: Change in HRQOL from baseline to 12 months after kidney transplantation ] [ Designated as safety issue: No ]Longitudinally monitoring of HRQOL from listing for transplantation and up to 5 years post transplantation
| Estimated Enrollment: | 135 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients older than 65 years listed for kidney transplantation on the Norwegian transplant wait list
Criteria
Inclusion Criteria:
- End stage renal disease listed for transplantation
- Age > 65 years
Exclusion Criteria:
- Not able to fulfill the HRQOL form
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760733
Contacts
| Contact: Kjersti Lønning, MSm | +4723073647 | klonning@ous-hf.no |
Locations
| Norway | |
| Oslo University Hospital, Rikshospitalet, Section of Nephrology | Recruiting |
| Oslo, Norway, 0424 | |
| Contact: Kjersti Lønning, MSm +4723073647 klonnin@ous-hf.no | |
| Contact: Karsten Midtvedt, MD, PhD +4723071894 kmidtved@ous-hf.no | |
| Principal Investigator: Karsten Midtvedt, MD, PhD | |
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
Investigators
| Principal Investigator: | Kristian Heldal, MD, PhD | Sykehuset Telemark |
More Information
No publications provided
| Responsible Party: | Kristian Heldal, Senior Physician, PhD, Sykehuset Telemark |
| ClinicalTrials.gov Identifier: | NCT01760733 History of Changes |
| Other Study ID Numbers: | STHF 81.25 |
| Study First Received: | December 17, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Norway: Ethics Committee |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
ClinicalTrials.gov processed this record on May 23, 2013