Kidney Transplantation, Renal Insuffiency
Conditions
Keywords
End Stage Renal Disease, Renal transplantation, Dialysis, Pre-emptive transplantation, Psychological adjustment, Quality of life.
Brief summary
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
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.
Interventions
OTHERQuestionnaires : Patient-Reported Outcomes
Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | through study completion, an average of 5 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depressive disorders | through study completion, an average of 5 years | Anxiety and depressive disorders will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the questionnaire HAD (Hospital Anxiety and Depression scale) |
| Subjective well-being | through study completion, an average of 5 years | Subjective well-being will be assessed every six months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the satisfaction with life scale (SWLS) |
| Perceived stress | through study completion, an average of 5 years | The perceived stress will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Perceived Stress Scale |
| Coping strategies | through study completion, an average of 5 years | The coping strategies will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Brief Cope |
| Posttraumatic growth | through study completion, an average of 5 years | The posttraumatic growth will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Posttraumatic Growth Inventory (PTGI) |
| Generic quality of life | through study completion, an average of 5 years | Generic QoL will be assessed with the SF36 every 6 months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT. |
| Evolution of daily proteinuria level | through study completion, an average of 5 years | The evolution of the daily proteinuria level will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and 3, 6,12, 24, 36, 48, 72 months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test |
| KTFS (Kidney Transplant Failure Score ) | 12 month | The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT. |
| Post-transplantation time to return to work | 24 month | — |
| Compliance of patients | through study completion, an average of 5 years | Compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Girerd questionnaire |
| Evolution of the Graft Filtration Rate | through study completion, an average of 5 years | 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 3, 6,12, 24, 36, 48, 72 months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula |
Countries
France
Outcome results
None listed