For a Better Interpretation of Quality of Life Scores of Kidney Transplant Patients: Determination of the Minimum Significant Change RetransQol (ReTransQol)

August 12, 2016 updated by: Assistance Publique Hopitaux De Marseille

The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.

The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

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
      • Marseille, France, 13354
        • Assistance Publique Hôpitaux de Marseille

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

Sampling Method

Probability Sample

Study Population

Kidneys transplanted patients

Description

Inclusion Criteria:

  • Patient with a transplant kidney

Exclusion Criteria:

  • Patient not able to answer survey

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of change in quality of life in kidneys transplantation patients using ReTransQol
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Stéphanie GENTILE, MD/PhD, Assistance Publique Hôpitaux de Marseille

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

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (ESTIMATE)

August 17, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-15
  • 2012-A00634-39 (OTHER: Ansm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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