Evaluation of Regret in Kidney Transplantation

Recruiting

• Conditions: Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney

• Registration Number: NCT05282381
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Kidney transplantation in the Lille University Hospital
• Functional kidney graft after 28 days post transplantation

Exclusion Criteria

• Previous other solid organ transplant
• Combined transplantation (kidney and liver for example)
• Cognitive disorders
• Lack of French language skill

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale	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

Secondary Outcome Measures

Name	Time	Method
Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale	At 1, 3, 6 and 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
Specific Quality of Life Scale (ReTransQoL)	At 1, 3, 6 and 12 months post-transplantation	The ReTransQoL (Renal Transplant Quality of Life) questionnaire is a quality of life related-questionnaire, specific for kidney transplant recipients and developed by Gentile et al. in 2008 (Gentile et al, Health Qual Life Outcomes, 2008). It consists in 49 items, divided into 5 dimensions: Physical Health, Medical Care, Fear of losing the Graft, Treatment and Mental Health. This results in a quality of life score, from 0 to 100 (0 being the lowest quality of life score).
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.	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

Trial Locations

Locations (1)

CHU Lille; 🇫🇷 Lille, France