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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468440
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Other: ESPAIR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ESPAIR
Patients with an educational therapy's program since registration in transplant list.
Other: ESPAIR
ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible

No Intervention: normal care
Patients without educational therapy



Primary Outcome Measures :
  1. Quality of life Questionnaire [ Time Frame: 6 months ]
    Quality of life 6 months after registration on transplant list.


Secondary Outcome Measures :
  1. Quality of life Questionnaire [ Time Frame: One year ]
    Quality of life one year after registration on transplant list.

  2. Quality of life Questionnaire [ Time Frame: 1 day ]
    Quality of life on the day of the transplantation

  3. Composite measure of impact of educational therapy's program [ Time Frame: 6 months ]
    Impact of educational therapy's program on anxiety, knowledge to prepare transplant, life hygiene, and patient compliance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468440


Locations
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France
Chu Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Laure Esposito, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02468440    
Other Study ID Numbers: 14 7314 02
2015/20 ( Registry Identifier: CPP SOOM III )
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Keywords provided by University Hospital, Toulouse:
renal insufficiency
kidney transplant
educational therapy
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases