- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02690272
"Lived Experience, Representations and Psychic Processes in Patients Awaiting Kidney Transplantation" (LER-Psy-PAKT)
October 30, 2017 updated by: University Hospital, Angers
" Expérience Vécue, Représentations et Processus Psychiques Chez Les Sujets en Attente de Transplantation Rénale "
The kidney transplant remains the privileged treatment of the terminal renal insufficiency.
This care is complex for the patient both on a medical surgical plan and by the psychic reorganizations.
Among the temporary contraindications of transplantation, us retrouvonsdes psychological reasons.
The research work consists in highlighting the psychic mechanisms of the subjects awaiting kidney transplant.
Study Overview
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years old
- stade 4 or 5 renal insufficiency
- Registered on waiting list for a first kidney transplant
Exclusion Criteria:
- in ward
- Unsigned consent
- Already transplanted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychic processes
Quantitative and qualitative approche of the psychic process for patients awaiting kidney transplant
|
Quantitative and qualitative aprroche of the psychic process
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure of anxiety
Time Frame: 6 months
|
STAI-Y questionnaire with 20 items used to measure anxiety degree
|
6 months
|
|
Measure of psychic representations around transplant
Time Frame: 6 months
|
ETA test: this test consists of an interview then the psychic projection through the drawing of 3 trees imagined by the patient and talking about him.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emmanuelle COURTILLIE, University Hospital, Angers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 29, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
September 11, 2017
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 19, 2016
First Posted (Estimate)
February 24, 2016
Study Record Updates
Last Update Posted (Actual)
November 1, 2017
Last Update Submitted That Met QC Criteria
October 30, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-A00971-48
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.