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.

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

Quality of Life

End Stage Renal Disease

End Stage Renal Failure on Dialysis

Aim 1:

      Evaluate the HRQoL longitudinally from time of wait listing and until 1 year after kidney
      transplantation among kidney transplant candidates older than 65 years of age.

      Data collection The HRQoL will be monitored in a prospective, longitudinal study
      (QUESTION65). A minimum of 200 patients will be included and the inclusion period is
      estimated to 2-3 years. All patients give informed consent when entering the study. In
      addition, all patients have signed an informed consent when included in the Norwegian Renal
      Registry which allows the use of unidentified data from the registry in research protocols.

      HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF-36)
      health Survey. This survey consists of two parts, a generic and disease specific part. The
      same questionnaire is used before and after transplantation. For improved evaluation of HRQoL
      data on response shift will be captured through questions related to personal preferences,
      values and internal standards. The result gathered will also be compared with data from an
      age matched Norwegian cohort.

      All patients over the age of 65 who are accepted for the kidney transplantation waiting list
      or living donor transplantation will receive an invitation to be included in the study. A new
      form will be distributed to included patients with intervals of six months until they are
      transplanted, permanently removed from the transplant waiting list or until death. Patients
      who are transplanted will receive a form at discharge from Oslo University Hospital,
      Rikshospitalet (10 weeks after transplantation), after six months and at one year.

      Aim 2:

      Explore the expectations of older kidney transplant candidates prior to transplantation and
      one year after transplantation.

      Data Collection:

      For the qualitative evaluation, 15-20 patients in dialysis will be included and a qualitative
      individual in-depth interview will be performed approximately one month after baseline HRQoL
      and repeated one year after transplantation. Selection will be made according to age and
      gender. Inclusion will continue until saturation is reached. Convenient variation and
      broadness in information will be secured in the sample. To secure shared decision making,
      patients will be invited to discuss the interview guide and design of the qualitative
      evaluation. Furthermore, the interview guide will be tested in a pilot study. An
      interview-manual will be used. We believe the results from the qualitative interviews also
      can be used to gain an improved understanding of the answers in the survey.

      Aim 3:

      Investigate the relationship between pre-transplant comorbidity, described by the Liu
      comorbidity index and post-operative complications, post-transplant 1 year survival and
      HRQoL.

      Data collection From 2012 we have included pre-transplant data according to the Liu
      comorbidity index as part of the routine work up of candidates for kidney transplantation.
      Complete data describing patient and transplant characteristics, including the Liu
      comorbidity index will be extracted from the Norwegian Renal Registry. These data will only
      be used as explanatory variables for the outcome of HRQoL/survival and are not reported as
      separate outcomes. In addition post-transplant morbidity and mortality will be extracted from
      the Norwegian Renal Registry. The data will be exported from the registry without any
      identification except from a patient number.

      In case of missing data from the registry, data will be retrieved from the patient records at
      Oslo University Hospital, Rikshospitalet. The key necessary for identification will be stored
      at the registry.

      Aim 4 Health economic evaluation. In this sub-study, we will use data from the Short Form 36
      (SF36) part of the KDQOL-SF questionnaire to calculate Quality Adjusted Life Years (QALY).
      Costs will be estimated for each patients using data from their hospital records.

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.

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

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.

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.

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.

Consultant nephrologist, PhD, MHA

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

Any associations between pre-transplant HRQoL/comorbidity and post transplant survival will be investigated using multivariable cox regression models.

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

About this trial

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Placebo

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