NCT02468440

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

3.6 years

First QC Date

June 7, 2015

Last Update Submit

April 1, 2019

Conditions

Renal Insufficiency

Keywords

renal insufficiencykidney transplanteducational therapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life Questionnaire

    Quality of life 6 months after registration on transplant list.

    6 months

Secondary Outcomes (3)

  • Quality of life Questionnaire

    One year

  • Quality of life Questionnaire

    1 day

  • Composite measure of impact of educational therapy's program

    6 months

Study Arms (2)

ESPAIR

EXPERIMENTAL

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

Other: ESPAIR

normal care

NO INTERVENTION

Patients without educational therapy

Interventions

ESPAIROTHER

ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible

ESPAIR

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Laure Esposito, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 10, 2015

Study Start

June 2, 2015

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Locations

FR(1)