QUESTION65: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [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.
- Health Economic Analyses [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
- Survival [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.
- Changes in Intermediate Term (Three Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [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.
- Changes in Long Term (5-10 Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire [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
- Associations Between Pre-transplant Patient and Transplant Characteristics and Intermediate Term (Three Years) Change in HRQoL [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
- Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University Hospital, Rikshospitalet, Section of Nephrology | Oslo | Norway | 0424 |
Sponsors and Collaborators
- Sykehuset Telemark
- Oslo University Hospital
Investigators
- Principal Investigator: Kristian Heldal, MD, PhD, Sykehuset Telemark
Study Documents (Full-Text)
More Information
Publications
None provided.- STHF 81.25
Study Results
Participant Flow
| Recruitment Details | All patients 65 years and older who were accepted on the Norwegian kidney transplantation waiting list between January 1st 2013 and November 30th 2016 were invited to participate (n = 437). 289 were included, reasons for exclusion were reluctant to participate ( n = 21), not meeting inclusion criteria (n = 21) and not responding (n = 105). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients Accepted for the Transplant Waiting List |
|---|---|
| Arm/Group Description | Patients accepted for the kidney transplantation waiting list at Oslo University Hospital between Jan 1 2013 and Nov 30 2016 were included and followed from time of acceptance and up to 10 years after transplantation |
| Period Title: Waiting List | |
| STARTED | 289 |
| COMPLETED | 217 |
| NOT COMPLETED | 72 |
| Period Title: Waiting List | |
| STARTED | 217 |
| COMPLETED | 0 |
| NOT COMPLETED | 217 |
Baseline Characteristics
| Arm/Group Title | Waiting List |
|---|---|
| Arm/Group Description | Patients on the waiting list for transplantation |
| Overall Participants | 289 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
289
100%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
70.6
|
| Sex: Female, Male (Count of Participants) | |
| Female |
93
32.2%
|
| Male |
196
67.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| Norway |
289
100%
|
| Health Related Quality of Life scores (KDQOL-SF) (scores on a scale SF-36 general health) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [scores on a scale SF-36 general health] |
49.9
(22.3)
|
Outcome Measures
| Title | Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire |
|---|---|
| Description | 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. |
| Time Frame | Change in health related quality of life from baseline to one year after transplantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Changes in SF-36 score for the dimension "general health" (GH) of the KDQOL-SF between baseline and one year after transplantation |
| Arm/Group Title | Waitlist | Transplanted |
|---|---|---|
| Arm/Group Description | Patients on the waiting list for transplantation | Patients who have received a transplant |
| Measure Participants | 289 | 217 |
| Mean (Standard Deviation) [score on a scale] |
49.5
(22.3)
|
68
(22)
|
| Title | Health Economic Analyses |
|---|---|
| Description | 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 |
| Time Frame | From baseline to three years post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Survival |
|---|---|
| Description | 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. |
| Time Frame | From baseline/last score before transplantation to transplantation/up to ten years post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Changes in Intermediate Term (Three Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire |
|---|---|
| Description | 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. |
| Time Frame | From baseline to three years post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Changes in Long Term (5-10 Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire |
|---|---|
| Description | 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. |
| Time Frame | From last score before transplantation to ten years post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Associations Between Pre-transplant Patient and Transplant Characteristics and Intermediate Term (Three Years) Change in HRQoL |
|---|---|
| Description | 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 |
| Time Frame | From last score before transplantation to three years post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival |
|---|---|
| Description | Any associations between pre-transplant HRQoL/comorbidity and post transplant survival will be investigated using multivariable cox regression models. |
| Time Frame | From transplantation and up to ten years post tx |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | This is an observational study describing HRQoL among elderly Kidney Transplant candidates, longitudinally before and after KTx. No experimental interventions are performed and consequently adverse advents other than death, graft loss and being removed from the waiting list are not collected. Data are reported continuously from the clinicians to the Norwegian Renal Registry and exported to the study database. We search the registry every month and update our study database accordingly. | |
|---|---|---|
| Adverse Event Reporting Description | The term serious adverse event describes number of patients who are removed from the transplantation waiting list because of medical reasons and patients with graft loss after transplantation. All cause mortality is reported from both patients on the waiting list and those who have received a transplant. | |
| Arm/Group Title | Question 65 | |
| Arm/Group Description | Patients on the waiting list for transplantation - 5 years post KTx Observational study | |
All Cause Mortality |
||
| Question 65 | ||
| Affected / at Risk (%) | # Events | |
| Total | 44/289 (15.2%) | |
Serious Adverse Events |
||
| Question 65 | ||
| Affected / at Risk (%) | # Events | |
| Total | 48/289 (16.6%) | |
| General disorders | ||
| Removed from the transplantation wait-list | 41/289 (14.2%) | 41 |
| Renal and urinary disorders | ||
| Graft loss | 7/217 (3.2%) | 7 |
Other (Not Including Serious) Adverse Events |
||
| Question 65 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/289 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | MD, PhD Kristian Heldal |
|---|---|
| Organization | Telemark Hospital Trust |
| Phone | +4790018417 |
| hkri@ous-hf.no |
- STHF 81.25