Evaluation of Regret in Kidney Transplantation

Renal Transplant Candidate for Right Kidney Clinical Trial

— DONOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282381
• Other study ID #: 2021_0272
• Secondary ID: 2021-A02002-39
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Lille
• Contact: Mehdi Maanaoui, MD
• Phone: 0320445962
• Email: mehdi.maanaoui[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Candidate for Left Kidney
• Renal Transplant Candidate for Right Kidney

Intervention

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.

Locations

Country	Name	City	State
France	CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.