Evaluation of Regret in Kidney Transplantation (DONOR)

Decisional Regret in a Prospective Cohort of Renal Transplant Recipients: the DONOR Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney
• Intervention / Treatment: Behavioral: DRS : Decision Regret Scale

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received a kidney transplant in the nephrology department of the Lille University Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort of renal transplant recipients	Behavioral: DRS : Decision Regret Scale; The DRS is a self-administered questionnaire including 5 items assessing decisional regret in a score graduated between 0 and 100 (0 = no regret).This scale is associated with the ReTransQoL, a specific quality of life questionnaire. Questionnaires are administrated at 1, 3, 6 and 12 months post-transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale	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	At 12 months post-transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Quality of Life Scale (ReTransQoL)	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).	At 1, 3, 6 and 12 months post-transplantation
Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale	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	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	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	At baseline, and during the 12 months follow-up period.

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Mehdi Maanaoui, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Kidney transplantation; Decisional regret
• Other Study ID Numbers: 2021_0272; 2021-A02002-39 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No