Health Related Quality of Life in ESRD Patients Older Than 65 Years (QUESTION65)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sykehuset Telemark
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014