Trials / Completed
CompletedNCT02154815
Pre-emptive Kidney Transplantation Quality of Life
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 390 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Questionnaires : 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 |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2018-09-01
- Completion
- 2024-07-25
- First posted
- 2014-06-03
- Last updated
- 2024-08-27
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02154815. Inclusion in this directory is not an endorsement.