RhEumatoid Arthritis MEDIcation Adherence
Recruiting · NCT05413759 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospices Civils de Lyon
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Rheumatoid arthritis (RA) is a public health issue because of its frequency, its functional consequences, the risk of morbidity and mortality and the costs incurred. A collaborative multiprofessional intervention initiated during hospitalization and continued after hospital discharge (ambulatory care ) would improve medication adherence in RA and therefore the health status of patients. Main objective: To compare, 12 months after the index hospitalization or consultation, the impact of pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician) on medication adherence to disease-modifying treatments of patients with RA compared to usual care without pharmaceutical care and specific multi-professional collaboration. Medication adherence to disease-modifying treatments will be assessed by the rate of coverage of disease-modifying treatments (or Medication Possession Ratio (MPR)). METHODOLOGY: Interventional, multicenter, controlled, randomized, open label study, comparing in parallel 2 groups of patients with rheumatoid arthritis initially hospitalized in a rheumatology department (pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician), initiated in the hospital and continued after hospital discharge (ambulatory care) vs traditional follow-up.
Who can take part
Inclusion criteria
- Patient with diagnosed rheumatoid arthritis (RA),
- Patient, male or female, aged 18 or over,
- Patient hospitalized or coming for a consultation in a rheumatology department, and returned home at hospital discharge
- Patient having DMARDs for RA (continuation or initiation) comprising at least methotrexate and/or a tsDMARD (targeted synthetic DMARD, JAK inhibitor) and/or subcutaneous bDMARD (biologic DMARD),
- Autonomous patient in the management of his drug treatment,
- Patient understanding and speaking French,
- Patient affiliated to the French general national health insurance or similar,
- Patient having given his free, informed and signed consent.
Exclusion criteria
- Patient whose usual pharmacy already has or has had a patient included in the INTERVENTION group in the study,
- Patient whose regular pharmacy is currently treating another patient.
- Patient with obvious significant cognitive or psychiatric disorders incompatible with the study (according to the judgment of the investigator),
- Patient whose management of his drug treatment at home is carried out exclusively by a carer,
- Patient participating in another research that may interfere (investigator's judgement) with the results of the present study,
- Adult patient protected under the terms of the law (Public Health Code),
- Patient not fit to carry out the follow-up, according to the judgment of the investigator,
- Pregnant or breastfeeding women.
Where it is running
2 locations listed.
- Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot - Lyon, France
- Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices Civils de Lyon - Pierre-Bénite, Lyon, France