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

Rheumatic Diseases Clinical Trial

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Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187794
• Other study ID #: 69HCL19_0746
• Status: Completed
• Start date: June 9, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Treatment Adherence

Intervention

Other:
• Interview patient
to investigate an association between literacy level and medication adherence in patients with rheumatic diseases.

Locations

Country	Name	City	State
France	Service de rhumatologie Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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