Clinical trial NCT06579222: Comorbidity Management in Rheumatic Disease.
Official title: Comorbidity Management in Rheumatic Disease: Assessing a Potential Care Gap in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Comorbidities and Coexisting Conditions
Keywords: rheumatoid arthritis
comorbidities
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Rheumatology Association (CIORA)
First posted: 2024-08-30
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rheumatoid arthritis is a disease where the immune system attacks the body by mistake, causing inflammation of the joints and other body parts. People with rheumatoid arthritis are at higher risk of infections, heart problems, and bone issues compared to others. They regularly see rheumatologists, arthritis care physicians, to manage their disease. However, managing these other health problems alongside their main treatment is difficult for rheumatologists due to limited resources. This clinical study is being conducted to see if adding a family doctor to a team of rheumatologists can help. Rheumatologists will complete a case report form about the patient's health and send them to a special family physician clinic. This clinic will focus on improving vaccination against diseases, heart health, and bone strength. They will check if patients need special vaccines to protect them from infections. They will screen for heart disease using blood pressure measurements, and order blood work for high cholesterol and diabetes if needed. They will also review bone health and send people for tests to check their bone density if needed. A change in routines and medications may be recommended after their checkup. Rheumatologists will complete another case report about the patient's health 6 months after their family doctor appointment. The study will assess how these markers of health management improve after this family doctor joins the team. It hopes to prove that this new way of working in the community will give people with rheumatoid arthritis better protection against certain infections, heart problems and weak bones.


Eligibility criteria: Inclusion Criteria: Participants will be patients of the Waterloo Rheumatology Community Clinic, aged 18 to 80 years of age, with a diagnosis of rheumatoid arthritis. Participants will have a minimum of limited working proficiency in English and no significant cognitive impairment that can inhibit their ability to engage in the study.

Exclusion Criteria: Age less than 18 years or greater than 80 years, significant cognitive impairment that impedes ability to engage in the study or unwilling to participate in the study. Patients that are currently pregnant will be excluded from the study as well. Whether or not a participant is enrolled with a primary care physician or nurse practitioner will not impact the intervention.

Primary outcomes:
measure: Care Gap: Pneumococcal vaccination
timeFrame: 6 months
measure: Care Gap: Cardiovascular screening
timeFrame: 6 months
measure: Care Gap: Osteoporosis screening
timeFrame: 6 months
Secondary outcomes:
measure: Care Gap: vaccine-preventable diseases (herpes zoster, influenza and COVID-19)
timeFrame: 6 months
measure: Care Gap: Comorbidity treatment with medication
timeFrame: 6 months
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Waterloo Rheumatology
state: Ontario
Study officials:
affiliation: Western University
name: Cassandra Schulz
role: PRINCIPAL_INVESTIGATOR
References: