NCT02690272

Brief 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. The research work consists in highlighting the psychic mechanisms of the subjects awaiting kidney transplant.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 29, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

February 11, 2016

Last Update Submit

October 30, 2017

Conditions

Kidney Tranplant

Keywords

kidney transplantpsychic process

Outcome Measures

Primary Outcomes (2)

  • Measure of anxiety

    STAI-Y questionnaire with 20 items used to measure anxiety degree

    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.

    6 months

Study Arms (1)

Psychic processes

EXPERIMENTAL

Quantitative and qualitative approche of the psychic process for patients awaiting kidney transplant

Behavioral: Psychic processes

Interventions

Psychic processesBEHAVIORAL

Quantitative and qualitative aprroche of the psychic process

Psychic processes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • stade 4 or 5 renal insufficiency
  • Registered on waiting list for a first kidney transplant

You may not qualify if:

  • in ward
  • Unsigned consent
  • Already transplanted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36670295DERIVED

Study Officials

  • Emmanuelle COURTILLIE

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 24, 2016

Study Start

February 29, 2016

Primary Completion

August 1, 2017

Study Completion

September 11, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10