RhEumatoid Arthritis MEDIcation Adherence
REMEDIA
Collaborative Pharmaceutical Care Initiated in Hospital and Continued in Primary Care to Improve Medication Adherence of Patients With Rheumatoid Arthritis
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Jun 2022
Longer than P75 for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 28, 2027
October 2, 2025
September 1, 2025
4.5 years
May 23, 2022
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence to rheumatoid arthritis treatment
The primary endpoint is the rate of adherent patients to DMARDs after 12 months of follow-up assessed by the Medication Possession Ratio (MPR). The MPR is calculated for each drug: total quantity of dose units dispensed compared to the theoretical quantity of dose units necessary for compliance with the prescribed dosage. The calculation will be made from: * dispensing data collected from the patient's community pharmacist (control and intervention group), * prescription data from all prescriptions (between Month 0 and Month 12), reported by the patient during the visit to Month 12, * and hospitalization data from the medicalized information system program (PMSI:) and the patient log. A patient is considered adherent to his treatment if the MPR is greater than or equal to 80%. For patients with more than one DMARD drug prescribed, they will be considered adherent if the MPR of each DMARD is greater than or equal to 80%.
Month 12
Secondary Outcomes (14)
Clinical criteria - Evolution of the Disease Activity Score DAS28
Day 0 and Month 12
Clinical criteria - Number of Rheumatoid Arthritis-related re-hospitalizations
Month 0 and Month 12
Clinical criteria - Number of adverse effects related to drug treatments leading to hospitalization.
Month 0 and Month 12
Functional and quality of life criteria - Evolution of the Health Assessment Questionnaire (HAQ) score
Day 0 and Month 12
Functional and quality of life criteria - Evolution of the EuroQol 5-Dimensional score (EQ-5D)
Day 0 and Month 12
- +9 more secondary outcomes
Study Arms (2)
Pharmaceutical care in multiprofessional collaboration
EXPERIMENTALMedication 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).
Control group (usual practices group)
NO INTERVENTIONUsual follow-up during the 12-month follow-up.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices Civils de Lyon
Pierre-Bénite, Lyon, 69495, France
Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot
Lyon, 69003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland CHAPURLAT, MD/PHD
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
June 10, 2022
Study Start
June 28, 2022
Primary Completion (Estimated)
December 28, 2026
Study Completion (Estimated)
December 28, 2027
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share