Therapeutic Literacy Evaluation in Liver Transplanted Patients (THELEHEPAT)

December 11, 2020 updated by: University Hospital, Clermont-Ferrand

Health literacy is a new concept in therapeutic patient education. Health Literacy has been defined as the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Health literacy seems predictive of adherence 's patients to treatment or positive health behavior.

Liver transplanted patients need to modify their lifestyle and to perform new behaviors in order to improve their survival and their quality of life. Health literacy evaluation in these patients is necessary to know what they understand and to improve their intake.

The Aim of the study is to evaluate health literacy among liver transplanted patient and to perform liver transplanted patient profiles related to their own health literacy.

The second aim is to study the impact of health literacy on medication adherence and iatrogenic hospitalizations It is a monocentric non-randomized study. During the hepatologist consultation, the HLQ Health Literacy Questionnaire is performed to explore patient health understanding and perception. Then the pharmacist interviews the patient to explore motivations and brakes for their own healthcare; Furthermore, a cognitive and precarity evaluation is performed in order to analyze psychological or social factors which can influence health literacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tests performed:

  • Health Literacy Questionnaire: HLQ
  • Montreal Cognitive Evaluation Assessment: MoCA
  • EPICES: precarity test validated in French
  • A qualitative interview

Study Type

Interventional

Enrollment (Actual)

53

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
      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient > 18 years
  • Liver transplanted patient > 1 year at the start of the study
  • patient who are followed-up by an hepatologist in the center
  • patient who understands and speaks French

Exclusion Criteria:

  • patient not yet liver transplanted (on the waiting-list)
  • patient who has not come back home yet
  • patient who does not speak or understand French
  • patient refusal to participate
  • patient under supervision or guardianship

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
liver transplanted patient
Other: HLQ (Health literacy questionnaire)
each patient complete survey and self-assessment questionnaire before or after his medical consultation
Other: MoCA (Montreal Cognitive Assessment)
each patient complete survey and self-assessment questionnaire before or after his medical consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health literacy questionnaire
Time Frame: day 1
a survey in 2 parts. Each part contains about twenty questions with Likert scale
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA questionnaire
Time Frame: day 1
evaluation of cognitive assessment and detection mild cognitive dysfunction at the consultation
day 1
EPICES questionnaire
Time Frame: day 1
auto-evaluation of social and economic status
day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Sarah Talavera, University Hospital, Clermont-Ferrand

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)

January 23, 2019

Primary Completion (Actual)

June 18, 2019

Study Completion (Actual)

June 18, 2019

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RBHP 2018 TALAVERA
  • 2018-A01031-54 (Other Identifier: 2018-A01031-54)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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