Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 5
- 主要终点
- Change in quality of life
研究概览
简要总结
The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.
详细描述
The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center).
- •Only first and single kidney transplantation will be considered.
排除标准
- •Re-transplantation or simultaneous transplantation (kidney-pancreas for instance)
- •Patients under guardianship.
结局指标
主要结局
Change in quality of life
时间窗: through study completion, an average of 5 years
The change in quality of life, taking into account psychological adjustment of the patient (response shift). This criterion will be measured by a specifically developed questionnaire : ReTransQol
次要结局
- Anxiety and depressive disorders(through study completion, an average of 5 years)
- Perceived stress(through study completion, an average of 5 years)
- Post-transplantation time to return to work(24 month)
- Evolution of daily proteinuria level(through study completion, an average of 5 years)
- Evolution of the Graft Filtration Rate(through study completion, an average of 5 years)
- Compliance of patients(through study completion, an average of 5 years)
- Posttraumatic growth(through study completion, an average of 5 years)
- KTFS (Kidney Transplant Failure Score )(12 month)
- Generic quality of life(through study completion, an average of 5 years)
- Subjective well-being(through study completion, an average of 5 years)
- Coping strategies(through study completion, an average of 5 years)