NCT07278609 The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
| NCT ID | NCT07278609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Rheumatic Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-29 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective observational quality improvement study is to determine if a physician tool, MedSafer, combined with educational brochures for patients, can help to reduce the use of 'potentially inappropriate medications' (PIMs) in adults aged 60 and over with rheumatic conditions and polypharmacy (taking 5 or more regular medications). Researchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following interventions: * MedSafer reports provided to treating physicians * EMPOWER consumer brochures provided to participants Participants will complete 4 study visits over 18-20 months during which researchers will collect information on medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life.
Eligibility Criteria
Inclusion Criteria: * Aged ≥60 * Followed by a rheumatologist at MUHC for an inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, spondyloarthritis), a systemic autoimmune rheumatic disease (such as systemic lupus erythematosus, inflammatory myositis, systemic sclerosis, antiphospholipid antibody syndrome, Sjogren syndrome, systemic vasculitis), or another chronic musculoskeletal or rheumatic condition (such as crystal arthritis and osteoarthritis) * Currently taking ≥5 regular medications and ≥1 PIM * Anticipated ongoing clinical follow-up in rheumatology at an interval of every 3-9 months Exclusion Criteria: * Unable to provide informed consent * Acute life-threatening illness or life expectancy \<12 months
Contact & Investigator
Arielle Mendel, MD MSc
PRINCIPAL INVESTIGATOR
RI-MUHC/MUHC
Frequently Asked Questions
Who can join the NCT07278609 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278609 currently recruiting?
Yes, NCT07278609 is actively recruiting participants. Contact the research team at arielle.mendel@mcgill.ca for enrollment information.
Where is the NCT07278609 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07278609 clinical trial?
NCT07278609 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Arielle Mendel, MD MSc at RI-MUHC/MUHC. The trial plans to enroll 100 participants.