Rheumatic DiseasesLINKNCT04187794
Rheumatic Diseases: Evaluation of Health LIteracy, Medication adhereNce and Knowledges
An observational study of Rheumatic Diseases and Treatment Adherence, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases, Treatment Adherence
- What is being tested?
- Interview patient
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2020to 28 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) hospitalized (conventional or day hospitalization) or in consultation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Interview patient
- Medical subject headings
- Rheumatic Diseases, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview patientOther
to investigate an association between literacy level and medication adherence in patients with rheumatic diseases.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start9 Jun 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Laure YAILIAN, PD, Principal investigator, Service hospitalier de rhumatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187794
- Sponsor's protocol ID
- 69HCL19_0746
- Acronym
- LINK
- Status last verified
- Jul 2021
- First submitted
- 3 Dec 2019
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04187794
- Acronym / sponsor ID
- LINK / 69HCL19_0746
- Conditions
- Rheumatic Diseases, Treatment Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) hospitalized (conventional or day hospitalization) or in consultation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview patientto investigate an association between literacy level and medication adherence in patients with rheumatic diseases. | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Laure YAILIAN, PD principal investigator
Service hospitalier de rhumatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Treatment Adherence, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Literacy and medication levels (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.