RhEumatoid Arthritis MEDIcation Adherence

NCT ID: NCT05413759

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2027-12-28

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmaceutical care in multiprofessional collaboration

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).

Group Type: EXPERIMENTAL

Pharmaceutical care in multiprofessional collaboration

Intervention Type: OTHER

In addition to usual practices: medication reconciliation and pharmaceutical motivational interviews with patients (discharge, 2 & 6 months).

Objective of medication reconciliation (admission): to detect and resolve unintended medication discrepancies between home medication list and treatment and hospital admission medication orders. Objective of medication reconciliation (discharge): to obtain an exact list of medication, to explain the medication modifications during hospitalization.

Objective of the Disease-Modifying Antirheumatic Drugs information interview (discharge): to provide information and to answer questions on the management of treatment, to deal with practical situations to assess patients' self-management skills.

Objective of interviews (2 & 6 months): to evaluate medications and their daily management, benefits and problems that patient may encounter, to assess the patient's ability to manage the treatment.

Control group (usual practices group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmaceutical care in multiprofessional collaboration

In addition to usual practices: medication reconciliation and pharmaceutical motivational interviews with patients (discharge, 2 & 6 months).

Objective of medication reconciliation (admission): to detect and resolve unintended medication discrepancies between home medication list and treatment and hospital admission medication orders. Objective of medication reconciliation (discharge): to obtain an exact list of medication, to explain the medication modifications during hospitalization.

Objective of the Disease-Modifying Antirheumatic Drugs information interview (discharge): to provide information and to answer questions on the management of treatment, to deal with practical situations to assess patients' self-management skills.

Objective of interviews (2 & 6 months): to evaluate medications and their daily management, benefits and problems that patient may encounter, to assess the patient's ability to manage the treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland CHAPURLAT, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices Civils de Lyon

Pierre-Bénite, Lyon, France

Site Status: NOT_YET_RECRUITING

Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Roland CHAPURLAT, MD/PHD

Role: CONTACT

roland.charpulat@chu-lyon.fr

04 72 11 74 82 ext. +33

Audrey JANOLY-DUMENIL, PharmD

Role: CONTACT

audrey.janoly-dumenil@chu-lyon.fr

04 72 11 91 82 ext. +33

Facility Contacts

Charline ESTUBLIER, MD

Role: primary

charline.estublier@chu-lyon.fr

04.78.86.65.63 ext. +33

Roland CHAPURLAT, MD/PHD

Role: primary

roland.charpulat@chu-lyon.fr

04 72 11 74 82 ext. +33

Audrey JANOLY-DUMENIL, PharmD

Role: backup

audrey.janoly-dumenil@chu-lyon.fr

04 72 11 91 82 ext. +33

Other Identifiers

69HCL20_0272

Identifier Type: -

Identifier Source: org_study_id