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

April 1, 2019 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Questionnaire
Time Frame: 6 months
Quality of life 6 months after registration on transplant list.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Questionnaire
Time Frame: One year
Quality of life one year after registration on transplant list.
One year
Quality of life Questionnaire
Time Frame: 1 day
Quality of life on the day of the transplantation
1 day
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Laure Esposito, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2015

Primary Completion (Actual)

January 14, 2019

Study Completion (Actual)

January 14, 2019

Study Registration Dates

First Submitted

June 7, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14 7314 02
  • 2015/20 (Registry Identifier: CPP SOOM III)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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