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Active, Not Recruiting

NCT Number: NCT05282381

Evaluation of Regret in Kidney Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale

    Time frame: 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 outcomes

  1. Specific Quality of Life Scale (ReTransQoL)

    Time frame: 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).

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

    Time frame: 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

  3. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: DONOR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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