Kidney TranplantLER-Psy-PAKTNCT02690272
"Lived Experience, Representations and Psychic Processes in Patients Awaiting Kidney Transplantation"
A study testing Psychic processes in people with Kidney Tranplant, run by University Hospital, Angers.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tranplant
- What is being tested?
- Psychic processes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 11 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old
- stade 4 or 5 renal insufficiency
- Registered on waiting list for a first kidney transplant
Who cannot join
- in ward
- Unsigned consent
- Already transplanted
About this study
Official title: " 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.
- Conditions
- Kidney Tranplant
- Being tested
- Psychic processes
- Keywords
- kidney transplant, psychic process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychic processesBehavioural
Quantitative and qualitative aprroche of the psychic process
| Study group | Role | What they receive |
|---|---|---|
| Psychic processes | Experimental | Quantitative and qualitative approche of the psychic process for patients awaiting kidney transplant Receives: Behavioral: Psychic processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of anxiety
STAI-Y questionnaire with 20 items used to measure anxiety degree
Measured: 6 months
Measure of psychic representations around transplant
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start29 Feb 2016
- Primary completionAug 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TranplantStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuelle COURTILLIE, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690272
- Sponsor's protocol ID
- 2015-A00971-48
- Acronym
- LER-Psy-PAKT
- Status last verified
- Oct 2017
- First submitted
- 11 Feb 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Courtillie E, Fromage B, Augusto JF, Saulnier P, Subra JF, Bonnaud-Antignac A. Waiting for a kidney transplant, a source of unavoidable but reversible anxiety: a prospective pilot study investigating a psychological intervention. J Nephrol. 2023 Apr;36(3):841-849. doi: 10.1007/s40620-022-01535-2. Epub 2023 Jan 21.
PubMed 36670295
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Expérience Vécue, Représentations et Processus Psychiques Chez Les Sujets en Attente de Transplantation Rénale "
- ClinicalTrials.gov ID
- NCT02690272
- Acronym / sponsor ID
- LER-Psy-PAKT / 2015-A00971-48
- Conditions
- Kidney Tranplant
- Keywords
- kidney transplant, psychic process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 29 Feb 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychic processes | Experimental | Behavioral: Psychic processesQuantitative and qualitative approche of the psychic process for patients awaiting kidney transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old
- stade 4 or 5 renal insufficiency
- Registered on waiting list for a first kidney transplant
Key exclusion criteria (3 listed)
- in ward
- Unsigned consent
- Already transplanted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychic processesQuantitative and qualitative aprroche of the psychic process | Behavioural | Psychic processes |
Primary outcome
Measure of anxiety
Time frame: 6 months
STAI-Y questionnaire with 20 items used to measure anxiety degree
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Derived from this study: PubMed 36670295Courtillie E, Fromage B, Augusto JF, Saulnier P, Subra JF, Bonnaud-Antignac A. Waiting for a kidney transplant, a source of unavoidable but reversible anxiety: a prospective pilot study investigating a psychological intervention. J Nephrol. 2023 Apr;36(3):841-849. doi: 10.1007/s40620-022-01535-2. Epub 2023 Jan 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle COURTILLIE principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
A study testing Psychic processes in people with Kidney Tranplant, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of anxiety (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.