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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPT | Patients with a pre-emptive kidney transplantation from deceased or living donors |
| |
| PDT | Patients who have experienced a pre-transplant dialysis period of less than 36 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires : Patient-Reported Outcomes | Other | Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months |
| 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 | through study completion, an average of 5 years |
| 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 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT. | through study completion, an average of 5 years |
| Anxiety and depressive disorders |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients waiting a kidney transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Véronique SEBILLE | Nantes University Hospital | Study Director |
| Aurélie MEURETTE | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique | Lyon | 69437 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26785745 | Derived | Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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) |
| through study completion, an average of 5 years |
| Subjective well-being | 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) | through study completion, an average of 5 years |
| Perceived stress | 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 | through study completion, an average of 5 years |
| Coping strategies | 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 | through study completion, an average of 5 years |
| Posttraumatic growth | 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) | through study completion, an average of 5 years |
| 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 3, 6,12, 24, 36, 48, 72 months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula | through study completion, an average of 5 years |
| 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 3, 6,12, 24, 36, 48, 72 months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test | through study completion, an average of 5 years |
| 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 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Girerd questionnaire | through study completion, an average of 5 years |
| CHU MARSEILLE - Hôpital de la Conception - Santé Publique |
| Marseille |
| 13005 |
| France |
| CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN | Nantes | 44093 | France |
| CHU NICE - Service de Néphrologie | Nice | 06002 | France |
| CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie | Toulouse | 61059 | France |
| Related Info | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |