CClinicalTrials.gg
CompletedNCT04187794LINKUpdated Jul 16, 2021

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

An observational study in Rheumatic Diseases and Treatment Adherence, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Rheumatic Diseases
  • Treatment Adherence
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In context

Rheumatic Diseases

377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's enrollment of 150 is below the median of 245 across 157 observational studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Interventions

  • OtherInterview patient

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

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What researchers measure

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).

    Time frame: At inclusion

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Study locations

1 site
  • Service de rhumatologie Hôpital Edouard Herriot
    Lyon, 69007, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04187794
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Dec 5, 2019
Start date
Jun 9, 2020
Primary completion
Jun 28, 2021
Completion
Jun 28, 2021
Last update
Jul 16, 2021

Study contacts

Anne Laure YAILIAN, PD
principal investigator · Service hospitalier de rhumatologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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