Rheumatic Diseases: Evaluation of Health LIteracy, Medication adhereNce and Knowledges (LINK)

July 15, 2021 updated by: Hospices Civils de Lyon

Assessment of the Literacy Level of Patients With Chronic Rheumatic Diseases and Association With the Level of Knowledge and Medication Adherence: For a Better Integration of Patients' Literacy Levels Into Their Therapeutic Management.

A medication non-adherence is reported in chronic rheumatic diseases, in a context of complex and long-term treatments (injectable/per os targeted therapies, biosimilar...). Understanding and integrating the patient into a shared medical decision are key factors for adherence. From this perspective, the level of literacy (an individual's ability to find, understand and use health information) must be explored in order to adapt the communication of information. These are currently insufficiently adapted to the individual understanding of patients. In practice, literacy assessment is very poorly integrated into routine care, while several tools are validated in French. In rheumatology, foreign studies have shown that literacy is positively related to knowledge level. The results remain contradictory regarding its association with medication adherence. Today, the literacy level of patients with rheumatic diseases and its impact on adherence has not been studied in France, although these evaluations would be useful to adapt interventions individually. The acceptance of patients to complete a literacy assessment questionnaire during their care should also be analysed as a condition of its deployment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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
      • Lyon, France, 69007
        • Service de rhumatologie Hôpital Edouard Herriot

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

Non-Probability Sample

Study Population

Patient with a rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) hospitalized (conventional or day hospitalization) or in consultation

Description

Inclusion Criteria:

  • patient older than 18 years
  • Having at least 6 months of disease-modifying rheumatic treatment (methotrexate and/or targeted treatment (anti-JAK) and/or subcutaneous biotherapies)
  • Understanding French,
  • With good visual acuity.

Exclusion Criteria:

  • Patients with cognitive disorders
  • Pregnant, parturient and lactating women
  • Persons deprived of their liberty
  • Major persons who are subject to a legal protection measure (guardianship, curators)
  • Persons not affiliated to a social security system

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
Measure Description
Time Frame
Correlation between Literacy and medication levels
Time Frame: At inclusion
Correlation coefficient between literacy level (HLS-EU-16: European Health Literacy scale) and medication adherence level (CQR: Compliance Questionnaire Rheumatology).
At inclusion

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Anne Laure YAILIAN, PD, Service hospitalier de rhumatologie

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)

June 9, 2020

Primary Completion (ACTUAL)

June 28, 2021

Study Completion (ACTUAL)

June 28, 2021

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0746

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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