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

NCT04187794 | Completed

• 1 other identifier: 69HCL19_0746
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases; Treatment Adherence

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Interview patient OTHER

to investigate an association between literacy level and medication adherence in patients with rheumatic diseases.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de rhumatologie Hôpital Edouard Herriot

Lyon, 69007, France

Location

MeSH Terms

Conditions

Rheumatic Diseases; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Study Officials

• Anne Laure YAILIAN, PD

  Service hospitalier de rhumatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: June 9, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

FR (1)