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Improved Selection of Elderly (> 65 Years) for Kidney Transplantation (QUESTION65)

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ClinicalTrials.gov Identifier: NCT01760733
Recruitment Status : Active, not recruiting
First Posted : January 4, 2013
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Kristian Heldal, Sykehuset Telemark

Brief Summary:
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 transplantation. Thereafter a new form will be completed after 10 weeks post transplant, 6 months, 1 year, 3 years and 5 years. In addition the study will explore the transplant candidates expectations in a qualitative study design and explore the relationship between pre-transplant comorbidity, HRQOL and survival.

Condition or disease
Quality of Life End Stage Renal Disease End Stage Renal Failure on Dialysis

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Study Type : Observational
Actual Enrollment : 289 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Study Start Date : December 2012
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [ Time Frame: Change in health related quality of life from baseline to one year after transplantation ]
    Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to one year post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores are obtained at baseline and every six months while patients were on the waiting list are performed. In addition scores are obtained obtained at two, six and twelve months after transplantation. Comparisons between last score obtained on the waiting list and score at twelve months after transplantation are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the scores at one year post transplant.

  2. Health Economic Analyses [ Time Frame: From baseline to three years post transplant ]
    Quality Adjusted Life Years (QALY) are calculated based on Short Form-6D extracted from the SF-36 part of the KDQOL survey while patients were on the waiting list and after transplantation. QALYs are compared between the waiting list and up to three years after transplantation. Costs will be calculated based on information from the patients records and cost/QALY will be compared for the two periods

  3. Survival [ Time Frame: From baseline/last score before transplantation to transplantation/up to ten years post transplant ]
    Patient survival on the waiting list and after transplantation will be calculated and compared using the Kaplan Meier method and a Cox regression analysis with a time dependent variable.

  4. Changes in Intermediate Term (Three Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [ Time Frame: From baseline to three years post transplant ]
    Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparison between last score obtained on the waiting list and the score at three years post transplant is performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at three years post transplant.

  5. Changes in Long Term (5-10 Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [ Time Frame: From last score before transplantation to ten years post transplant ]
    Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition, scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparisons between last score obtained on the waiting list and the score at five and ten years post transplant are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at five and ten years post transplant.


Secondary Outcome Measures :
  1. Associations Between Pre-transplant Patient and Transplant Characteristics and Intermediate Term (Three Years) Change in HRQoL [ Time Frame: From last score before transplantation to three years post transplant ]
    Demographic, medical and transplant characteristics were included in multivariable regression models to analyze any associations between these variables and any change in HRQoL described as KDQOL-SF scores between last score before transplantation and three years post transplantation

  2. Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival [ Time Frame: From transplantation and up to ten years post tx ]
    Any associations between pre-transplant HRQoL/comorbidity and post transplant survival will be investigated using multivariable cox regression models.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760733


Locations
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Norway
Oslo University Hospital, Rikshospitalet, Section of Nephrology
Oslo, Norway, 0424
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
Investigators
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Principal Investigator: Kristian Heldal, MD, PhD Sykehuset Telemark
  Study Documents (Full-Text)

Documents provided by Kristian Heldal, Sykehuset Telemark:
Publications of Results:
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Responsible Party: Kristian Heldal, Consultant nephrologist, PhD, MHA, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01760733    
Other Study ID Numbers: STHF 81.25
First Posted: January 4, 2013    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency