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Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant (ESPAIR)

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESPAIR
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Insufficiency focused on measuring renal insufficiency, kidney transplant, educational therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with renal insufficiency on dialysis or not
  • Registered on transplant list

Exclusion Criteria:

  • Patient with psychological disorder
  • transplantation from living donor
  • Patients with renal transplant antecedent

Sites / Locations

  • Chu Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESPAIR

normal care

Arm Description

Patients with an educational therapy's program since registration in transplant list.

Patients without educational therapy

Outcomes

Primary Outcome Measures

Quality of life Questionnaire
Quality of life 6 months after registration on transplant list.

Secondary Outcome Measures

Quality of life Questionnaire
Quality of life one year after registration on transplant list.
Quality of life Questionnaire
Quality of life on the day of the transplantation
Composite measure of impact of educational therapy's program
Impact of educational therapy's program on anxiety, knowledge to prepare transplant, life hygiene, and patient compliance.

Full Information

First Posted
June 7, 2015
Last Updated
April 1, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02468440
Brief Title
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
Acronym
ESPAIR
Official Title
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2015 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
renal insufficiency, kidney transplant, educational therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPAIR
Arm Type
Experimental
Arm Description
Patients with an educational therapy's program since registration in transplant list.
Arm Title
normal care
Arm Type
No Intervention
Arm Description
Patients without educational therapy
Intervention Type
Other
Intervention Name(s)
ESPAIR
Intervention Description
ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible
Primary Outcome Measure Information:
Title
Quality of life Questionnaire
Description
Quality of life 6 months after registration on transplant list.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life Questionnaire
Description
Quality of life one year after registration on transplant list.
Time Frame
One year
Title
Quality of life Questionnaire
Description
Quality of life on the day of the transplantation
Time Frame
1 day
Title
Composite measure of impact of educational therapy's program
Description
Impact of educational therapy's program on anxiety, knowledge to prepare transplant, life hygiene, and patient compliance.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with renal insufficiency on dialysis or not Registered on transplant list Exclusion Criteria: Patient with psychological disorder transplantation from living donor Patients with renal transplant antecedent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Esposito, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant

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