THELEHEPAT: Therapeutic Literacy Evaluation in Liver Transplanted Patients

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT04189380
Collaborator
(none)
53
1
1
4.8
11

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HLQ (Health literacy questionnaire)
  • Other: MoCA (Montreal Cognitive Assessment)
N/A

Detailed Description

Tests performed:
  • Health Literacy Questionnaire: HLQ

  • Montreal Cognitive Evaluation Assessment: MoCA

  • EPICES: precarity test validated in French

  • A qualitative interview

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Therapeutic Literacy Evaluation in Liver Transplanted Patients
Actual Study Start Date :
Jan 23, 2019
Actual Primary Completion Date :
Jun 18, 2019
Actual Study Completion Date :
Jun 18, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. health literacy questionnaire [day 1]

    a survey in 2 parts. Each part contains about twenty questions with Likert scale

Secondary Outcome Measures

  1. MoCA questionnaire [day 1]

    evaluation of cognitive assessment and detection mild cognitive dysfunction at the consultation

  2. EPICES questionnaire [day 1]

    auto-evaluation of social and economic status

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Clermont Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT04189380
Other Study ID Numbers:
  • RBHP 2018 TALAVERA
  • 2018-A01031-54
First Posted:
Dec 6, 2019
Last Update Posted:
Dec 14, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand

Study Results

No Results Posted as of Dec 14, 2020