- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254546
A Qualitative Study on Gratitude and Recognition Toward Living Kidney Donors (GRACE)
GRAtitude et Considération Envers Les Donneurs Vivants du Rein
Kidney transplantation is widely recognized as the best treatment for patients with end-stage renal disease. However, its development is limited by the persistent shortage of available organs. Living donor kidney transplantation offers the best functional and survival outcomes, yet the number of procedures remains insufficient.
Living kidney donation relies on a voluntary and altruistic act by a healthy individual who accepts surgery without direct medical benefit. This act of generosity raises important questions regarding how society acknowledges and values such commitment. The lack of formal recognition may contribute to the psychological burden experienced by some donors and may not adequately reflect the gratitude of the medical community and society toward them.
This study aims to explore the perceptions of living kidney donors regarding the potential implementation of a symbolic form of recognition (for instance, a commemorative medal) offered after donation. The hypothesis is that such recognition could improve donors' post-donation experience and strengthen the societal value associated with living organ donation, while fully respecting ethical principles prohibiting any financial reward.
This is a qualitative, monocentric study based on semi-structured interviews with individuals who have donated a kidney. The interviews will focus on donors' motivations, their personal experience of donation, and their opinions about different possible forms of post-donation recognition. Interviews will be recorded, transcribed verbatim, and analyzed using inductive thematic analysis to identify recurring themes and perspectives.
The main endpoint is the identification of thematic categories related to donors' perception of post-donation recognition and its potential impact on their experience. Secondary objectives include exploring donors' expectations regarding societal gratitude, their views on the symbolic value of such recognition, and the potential influence on future donor engagement.
The findings of this study are expected to contribute to the ethical reflection surrounding the acknowledgment of living donors, support initiatives promoting non-financial recognition, and help develop respectful and meaningful ways of expressing societal gratitude toward those who make the gift of life possible.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jérôme Lambert, MD PhD
- Phone Number: +33 0142499742
- Email: jerome.lambert@u-paris.fr
Study Contact Backup
- Name: Emilien Seizilles de Mazancourt, MD
- Phone Number: +33 +33(0)1.42.49.96.14
- Email: emilien.seizillesdemazancourt@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals who have donated a kidney at Hôpital Saint-Louis between January 1, 2020, and December 31, 2025, or are currently engaged in a living kidney donation process with nephrectomy scheduled before June 30, 2026.
- Age ≥ 18 years.
- Able to provide informed consent.
Exclusion Criteria:
- Refusal or opposition to participate in the study.
- Individuals under legal protection (guardianship, curatorship, or legal safeguard).
- Individuals deprived of liberty by judicial or administrative decision.
- Individuals under 18 years of age.
- Kidney donation performed in a hospital other than Hôpital Saint-Louis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Living donors of Kidney
This cohort includes individuals who have donated a kidney at Hôpital Saint-Louis between January 1, 2020, and December 31, 2025, as well as individuals currently engaged in a living kidney donation process with a nephrectomy planned before June 30, 2026, in the same institution.
Participants will take part in semi-structured qualitative interviews exploring their perceptions and experiences related to post-donation recognition.
|
Participants will take part in a one-on-one semi-structured qualitative interview exploring their experiences and perceptions related to living kidney donation and potential forms of post-donation recognition. The interview guide includes open-ended questions addressing:
Interviews will last approximately 45 to 60 minutes and will be conducted either in person at Hôpital Saint-Louis or via secure videoconference. All interviews will be recorded, transcribed verbatim, anonymized, and analyzed using inductive thematic analysis (NVivo or equivalent software). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Themes related to donor perceptions of post-donation recognition
Time Frame: At baseline
|
Inductive thematic analysis of semi-structured interviews with living kidney donors, identifying key themes and subthemes related to their perception of post-donation recognition or symbolic rewards (e.g., commemorative medal, public acknowledgment).
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of Kidney Paired Donation (KPD)
Time Frame: At baseline
|
Exploration of participants' views and emotional responses toward kidney paired donation programs, including ethical and logistical aspects. A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
|
Initial Motivations for Donation
Time Frame: At baseline
|
Identification of personal, relational, or altruistic motivations that led participants to consider or complete living kidney donation. A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
|
Experience of the Donation Pathway
Time Frame: At baseline
|
Evaluation of participants' experiences throughout the donation process, including emotional journey, perceived support, and acknowledgment by healthcare professionals. A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
|
Ethical Perceptions of Living Donation and Symbolic Recognition
Time Frame: At baseline
|
Analysis of ethical reflections expressed by donors regarding the concept of recognition, symbolic rewards, or institutional gratitude (e.g., medals, diplomas, ceremonies). A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
|
Social Representations of Living Donation
Time Frame: At baseline
|
Investigation of how donors perceive societal and familial views about living kidney donation, including stigma, admiration, or misunderstanding. A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
|
Barriers or Reluctance Toward Kidney Paired Donation
Time Frame: At baseline
|
Identification of logistical, emotional, or ethical barriers expressed by participants regarding paired exchange donation. A semi-structured interview lasting 30-60 minutes, either in person during another scheduled treatment or via videoconference. |
At baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP251133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Transplantation
-
Astellas Pharma IncAstellas Pharma Europe B.V.CompletedKidney Transplantation | Renal Transplantation | Transplantation, Kidney | Grafting, Kidney | Transplantation, RenalBelgium, Germany, Spain, Sweden, Italy, Switzerland, United Kingdom, Austria, France, Poland, Czech Republic, Netherlands
-
Bristol-Myers SquibbCompletedKidney Transplantation: Transplantation, Kidney
-
Hospices Civils de LyonCompletedKidney Transplantation | Pancreas-kidney TransplantationFrance
-
Nantes University HospitalTerminated
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
Astellas Pharma Europe Ltd.TerminatedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
-
Medical University of ViennaUnknownKidney Function After Transplantation | Outcome After Kidney Transplantation
Clinical Trials on Semi-structured qualitative interview
-
City, University of LondonUniversity College London HospitalsCompletedMultiple SclerosisUnited Kingdom
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustNot yet recruitingRehabilitation | Clinical Reasoning | Medical Record Documenation
-
University of NottinghamCompletedRheumatoid Arthritis | Systemic Lupus Erythematosus | Inflammatory Bowel Diseases | Vasculitis | Psoriatic Arthritis | Ankylosing Spondylitis | Reactive Arthritis | Inflammatory DiseaseUnited Kingdom
-
University Hospital Center of MartiniqueKaFE Association (Karaib Formation Etudes)Not yet recruitingCancer | Oncology | Oncologic DiseasesMartinique
-
University Hospital, MontpellierRecruiting
-
University of Colorado, DenverOrthotic and Prosthetic Education and Research Foundation (OPERF)Completed
-
University Hospital, LinkoepingCompletedPatient Experience | Emergency Department Visit | Qualitative Research | Frailty in AgingSweden
-
University Hospital, GrenobleNot yet recruiting
-
University Hospital, AntwerpRecruitingAnxiety | Elective Surgery | Chronic Post Surgical PainBelgium
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Multiple Sclerosis | Parkinson Disease | Rehabilitation | Neurologic Disorder | NeurosurgeryItaly