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

Completed

• Conditions: Rheumatic Diseases; Treatment Adherence

• Registration Number: NCT04187794
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-06-09
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Service de rhumatologie Hôpital Edouard Herriot; 🇫🇷 Lyon, France