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
About this trial
This is an interventional supportive care trial for Renal Insufficiency focused on measuring renal insufficiency, kidney transplant, educational therapy
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
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
NCT ID
NCT02468440
First Posted
June 7, 2015
Last Updated
April 1, 2019
Sponsor
University Hospital, Toulouse
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
Learn more about this trial
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
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