Clinical trial NCT01760733: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Official title: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Quality of Life
End Stage Renal Disease
End Stage Renal Failure on Dialysis
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2013-01-04
Enrollment: 289
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 65 years listed for kidney transplantation on the Norwegian transplant wait list

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* End stage renal disease listed for transplantation
* Age \> 65 years

Exclusion Criteria:

* Not able to fulfill the HRQOL form

Primary outcomes:
measure: Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire
timeFrame: Change in health related quality of life from baseline to one year after transplantation
measure: Health Economic Analyses
timeFrame: From baseline to three years post transplant
measure: Survival
timeFrame: From baseline/last score before transplantation to transplantation/up to ten years post transplant
measure: Changes in Intermediate Term (Three Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire
timeFrame: From baseline to three years post transplant
measure: Changes in Long Term (5-10 Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire
timeFrame: From last score before transplantation to ten years post transplant
Secondary outcomes:
measure: Associations Between Pre-transplant Patient and Transplant Characteristics and Intermediate Term (Three Years) Change in HRQoL
timeFrame: From last score before transplantation to three years post transplant
measure: Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival
timeFrame: From transplantation and up to ten years post tx
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet, Section of Nephrology
Study officials:
affiliation: Sykehuset Telemark
name: Kristian Heldal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lonning K, Midtvedt K, Heldal K, Andersen MH. Older kidney transplantation candidates' expectations of improvement in life and health following kidney transplantation: semistructured interviews with enlisted dialysis patients aged 65 years and older. BMJ Open. 2018 Jun 22;8(6):e021275. doi: 10.1136/bmjopen-2017-021275.
citation: Lonning K, Heldal K, Bernklev T, Brunborg C, Andersen MH, von der Lippe N, Reisaeter AV, Line PD, Hartmann A, Midtvedt K. Improved Health-Related Quality of Life in Older Kidney Recipients 1 Year After Transplantation. Transplant Direct. 2018 Mar 1;4(4):e351. doi: 10.1097/TXD.0000000000000770. eCollection 2018 Apr.
citation: Lonning K, Midtvedt K, Bernklev T, Brunborg C, Andersen MH, von der Lippe N, Reisaeter AV, Line PD, Hartmann A, Heldal K. Changes in health-related quality of life in older candidates waiting for kidney transplantation. Nephrology (Carlton). 2018 Oct;23(10):948-956. doi: 10.1111/nep.13117.