Pre-emptive Kidney Transplantation Quality of Life

Study Overview
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Brief Summary
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The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

Detailed Description
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The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.

Official Title
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Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years

Conditions
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Renal Insuffiency, Kidney Transplantation

Intervention / Treatment
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* Other: Questionnaires : Patient-Reported Outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center). Only first and single kidney transplantation will be considered. Exclusion Criteria: Re-transplantation or simultaneous transplantation (kidney-pancreas for instance) Patients under guardianship.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPT<br>Patients with a pre-emptive kidney transplantation from deceased or living donors | Other: Questionnaires : Patient-Reported Outcomes<br>* Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, and 24 months<br>|
| PDT<br>Patients who have experienced a pre-transplant dialysis period of less than 36 months | Other: Questionnaires : Patient-Reported Outcomes<br>* Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, and 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | The change in quality of life, taking into account psychological adjustment of the patient (response shift). This criterion will be measured by a specifically developed questionnaire : ReTransQol | every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic quality of life | Generic QoL will be assessed with the SF36 every 6 months prior to surgery, at hospital discharge and at three, six, 12, and 24 months, and compared between PPT versus PDT. | every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Anxiety and depressive disorders | Anxiety and depressive disorders will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT using the questionnaire HAD (Hospital Anxiety and Depression scale) | every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Subjective well-being | Subjective well-being will be assessed every six months prior to surgery, at hospital discharge and at three, six, 12, and 24 months, and compared between PPT versus PDT using the satisfaction with life scale (SWLS) | every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Perceived stress | The perceived stress will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT with the Perceived Stress Scale | every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Coping strategies | The coping strategies will be assessed at six and 24 months post transplantation and compared between PPT versus PDT with the Brief Cope | six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Posttraumatic growth | The posttraumatic growth will be assessed at six and 24 months post transplantation and compared between PPT versus PDT with the Posttraumatic Growth Inventory (PTGI) | six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 
| Evolution of the Graft Filtration Rate | The evolution of the Graft Filtration Rate (GFR) will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and three, six, 12 and 24-months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula | hospital discharge, and 3, 6, 12, and 24 months | 
| Evolution of daily proteinuria level | The evolution of the daily proteinuria level will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and three, six, 12 and 24-months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test | hospital discharge, and 3, 6, 12, and 24 months | 
| KTFS (Kidney Transplant Failure Score ) | The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT. | 12 month | 
| Post-transplantation time to return to work |  | 24 month | 
| Compliance of patients | Compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT with the Girerd questionnaire | six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological adjustment, End Stage Renal Disease, Renal transplantation, Dialysis, Pre-emptive transplantation, Quality of life.