Clinical trial NCT05413759: RhEumatoid Arthritis MEDIcation Adherence
Official title: Collaborative Pharmaceutical Care Initiated in Hospital and Continued in Primary Care to Improve Medication Adherence of Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: medication adherence
rheumatoid arthritis
pharmaceutical care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Medication adherence to rheumatoid arthritis treatment
timeFrame: Month 12
Secondary outcomes:
measure: Clinical criteria - Evolution of the Disease Activity Score DAS28
timeFrame: Day 0 and Month 12
measure: Clinical criteria - Number of Rheumatoid Arthritis-related re-hospitalizations
timeFrame: Month 0 and Month 12
measure: Clinical criteria - Number of adverse effects related to drug treatments leading to hospitalization.
timeFrame: Month 0 and Month 12
measure: Functional and quality of life criteria - Evolution of the Health Assessment Questionnaire (HAQ) score
timeFrame: Day 0 and Month 12
measure: Functional and quality of life criteria - Evolution of the EuroQol 5-Dimensional score (EQ-5D)
timeFrame: Day 0 and Month 12
measure: Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Medication Possession Ratio for each disease-modifying antirheumatic drug (DMARD)
timeFrame: Month 12
measure: Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Adherent rate according to the Compliance Questionnaire on Rheumatology (CQR)
timeFrame: Month 12
measure: Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Evolution of the BioSecure score or Knowledge score (Methotrexate and/or anti-JAK)
timeFrame: Day 0 and Month 12
measure: Criteria for patient behavior in relation to their disease-modifying antirheumatic drugs (DMARDs) - Evolution of the Beliefs about Medicines Questionnaire (BMQ) score
timeFrame: Day 0 and Month 12
measure: Economic criterion
timeFrame: Month 12
measure: Intervention implementation and acceptability criteria - Satisfaction of pharmacists and general practitioners through semi-structured interviews
timeFrame: Month 12
measure: Intervention implementation and acceptability criteria - Duration of follow-up interviews measured by community pharmacist
timeFrame: Month 2 and Month 6
measure: Intervention implementation and acceptability criteria - Number of patients having benefited from a complete follow-up by the town pharmacist (participation in the 2 scheduled meetings to reinforce medication adherence)
timeFrame: Month 12
measure: Intervention implementation and acceptability criteria - Patient satisfaction by questionnaire
timeFrame: Month 12
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de rhumatologie, Centre Hospitalier Lyon Sud, Groupement Hospitalier Sud, Hospices Civils de Lyon
state: Lyon
city: Lyon
country: France
facility: Service de rhumatologie et pathologie osseuse - Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Roland CHAPURLAT, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: