RhEumatoid Arthritis MEDIcation Adherence (REMEDIA)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Other: Pharmaceutical care in multiprofessional collaboration

Study type: Interventional

Funder types: Other

Identifiers

NCT05413759

69HCL20_0272

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 a patient included in the study,
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pharmaceutical care in multiprofessional collaboration

Experimental group

Description:

Medication reconciliation (hospital admission and discharge), disease-modifying antirheumatic drugs (DMARD) treatment information interview and 2 motivational interviews (after discharge, at 2 months and 6 months after the inclusion).

Treatment:

Other: Pharmaceutical care in multiprofessional collaboration

Control group (usual practices group)

No Intervention group

Description:

Usual follow-up during the 12-month follow-up.