Evaluation of Regret in Kidney Transplantation

NCT05282381 | Unknown

• 2 other identifiers: 2021_02722021-A02002-39
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney

Keywords

Decisional regret; Kidney transplantation; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specific Quality of Life Scale (ReTransQoL)

  At 1, 3, 6 and 12 months post-transplantation

• Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale

  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.

Study Arms (1)

Cohort of renal transplant recipients

Behavioral: DRS : Decision Regret Scale

Interventions

DRS : Decision Regret Scale BEHAVIORAL

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.

Cohort of renal transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU Lille

Lille, 59000, France

RECRUITING

Study Officials

• Mehdi Maanaoui, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehdi Maanaoui, MD

CONTACT

0320445962; mehdi.maanaoui@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (1)