Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease listed for transplantation
- •Age > 65 years
排除标准
- •Not able to fulfill the HRQOL form
结局指标
主要结局
Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival(From transplantation and up to ten years post tx)
研究者
Kristian Heldal
Consultant nephrologist, PhD, MHA
Sykehuset Telemark