NCT04189380

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

November 28, 2019

Last Update Submit

December 11, 2020

Conditions

Keywords

Health literacyliver transplanted patientscognitive evaluationsocial status

Outcome Measures

Primary Outcomes (1)

  • health literacy questionnaire

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

    day 1

Secondary Outcomes (2)

  • MoCA questionnaire

    day 1

  • EPICES questionnaire

    day 1

Study Arms (1)

Cohort 1

EXPERIMENTAL

liver transplanted patient

Other: HLQ (Health literacy questionnaire)Other: MoCA (Montreal Cognitive Assessment)

Interventions

each patient complete survey and self-assessment questionnaire before or after his medical consultation

Cohort 1

each patient complete survey and self-assessment questionnaire before or after his medical consultation

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Sarah Talavera

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 6, 2019

Study Start

January 23, 2019

Primary Completion

June 18, 2019

Study Completion

June 18, 2019

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations