Decisional Regret in a Prospective Cohort of Renal Transplant Recipients: the DONOR Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
研究概览
简要总结
Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. This decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. Although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. The DONOR study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. The decisional regret will be assessed by the DRS ("Decisional Regret Scale"), associated with the RetransQoL, a quality of life questionnaire.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation in the Lille University Hospital
- •Functional kidney graft after 28 days post transplantation
排除标准
- •Previous other solid organ transplant
- •Combined transplantation (kidney and liver for example)
- •Cognitive disorders
- •Lack of French language skill
结局指标
主要结局
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
时间窗: At 12 months post-transplantation
The decisional regret scale consists of five items addressing the notion of regret from different perspectives. The patient is asked to respond to each item using a 5-point Likert-type scale. The results of the Decisional Regret Scale are converted into a score from 0 to 100, with values increasing in multiples of 5. A score of 0 means no regret. Three categories of the DRE score were created: no regret (score = 0), low regret (score between 5 and 25), and moderate to high regret (score ≥ 30
次要结局
- Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale(At 1, 3, 6 and 12 months post-transplantation)
- Specific Quality of Life Scale (ReTransQoL)(At 1, 3, 6 and 12 months post-transplantation)
- Identification of biological, psychological and sociological risk factors for decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale(At baseline, and during the 12 months follow-up period.)