Rheumatoid ArthritisNCT06579222
Comorbidity Management in Rheumatic Disease.
A study testing Primary Care Rheumatology Family Physician Consultation in people with Rheumatoid Arthritis and Comorbidities and Coexisting Conditions, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Comorbidities and Coexisting Conditions
- What is being tested?
- Primary Care Rheumatology Family Physician Consultation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 19 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the Waterloo Rheumatology Community Clinic
- Aged 18 to 80 years of age
- Diagnosis of rheumatoid arthritis
- Minimum of limited working proficiency in English
- No significant cognitive impairment that can inhibit their ability to engage in the study
Who cannot join
- Age less than 18 years or greater than 80 years
- Significant cognitive impairment that impedes ability to engage in the study
- Unwilling to participate in the study
- Patients currently pregnant will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Waterloo Rheumatology
Waterloo, Ontario, N2T 0C2
Cassandra Schulz, MD, (519) 279-4047, wrheumatologystudy@gmail.com
Yan Yeung, MD
About this study
Official title: Comorbidity Management in Rheumatic Disease: Assessing a Potential Care Gap in Patients With Rheumatoid Arthritis.
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.
- Being tested
- Primary Care Rheumatology Family Physician Consultation
- Keywords
- rheumatoid arthritis, comorbidities
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Rheumatology Family Physician ConsultationOther
The participant will be booked with a primary care rheumatology family physician for rheumatoid arthritis comorbidity screening. They will complete weight, height, blood pressure measurement, assess for risk factors for dyslipidemia, type 2 diabetes, hypertension, bone mineral density loss and vaccine preventable infectious diseases.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Comorbidity Clinic | Experimental | The following investigations and treatments will be offered as associated with a comprehensive comorbidity clinic appointment with the primary care rheumatology family physician: Blood pressure, heart rate, height and weight measurement. Blood work (standard lipid panel, fasting plasma glucose or glycated hemoglobin (A1C), eGFR, and Lipoprotein a, Bone densitometry (if applicable to the patient/participant).
Vaccinations will be offered if applicable to the patient/participant according to Health Canada guidelines (Vaccination with Pneu-P-23, Pneu-C-13, herpes zoster and COVID-19 vaccine). Receives: Other: Primary Care Rheumatology Family Physician Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Gap: Pneumococcal vaccination
the number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and addressed within 6 months of comorbidity clinic intervention, for pneumococcal vaccination.
Measured: 6 months
Care Gap: Cardiovascular screening
the number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and addressed within 6 months of comorbidity clinic intervention, for cardiovascular screening (determined by meeting a combination of blood pressure, cholesterol and blood sugar measurement guidelines)
Measured: 6 months
Care Gap: Osteoporosis screening
The number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) for osteoporosis prevention and screening (determined by meeting guidelines for Vitamin D supplementation and bone densitometry completion)
Measured: 6 months
Secondary outcomes (2)
Care Gap: vaccine-preventable diseases (herpes zoster, influenza and COVID-19)
the number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and managed for remaining vaccine-preventable diseases (herpes zoster, influenza and COVID-19).
Measured: 6 months
Care Gap: Comorbidity treatment with medication
(percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and managed for the initiation of antihypertensive agents, cholesterol-lowering medications or medications for type 2 diabetes in study participants within the 6 months following the comprehensive comorbidity clinic.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 May 2025
- Primary completion19 Jun 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Rheumatology Association (CIORA)
- Responsible party
- Sponsor
- Investigators
- Cassandra Schulz, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579222
- Sponsor's protocol ID
- 125677
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidity Management in Rheumatic Disease: Assessing a Potential Care Gap in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT06579222
- Acronym / sponsor ID
- 125677
- Keywords
- rheumatoid arthritis, comorbidities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Canadian Rheumatology Association (CIORA)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 19 Jun 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Comorbidity Clinic | Experimental | Other: Primary Care Rheumatology Family Physician ConsultationThe following investigations and treatments will be offered as associated with a comprehensive comorbidity clinic appointment with the primary care rheumatology family physician: Blood pressure, heart rate, height and weight measurement. Blood work (standard lipid panel, fasting plasma glucose or glycated hemoglobin (A1C), eGFR, and Lipoprotein a, Bone densitometry (if applicable to the patient/participant). Vaccinations will be offered if applicable to the patient/participant according to Health Canada guidelines (Vaccination with Pneu-P-23, Pneu-C-13, herpes zoster and COVID-19 vaccine). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of the Waterloo Rheumatology Community Clinic
- Aged 18 to 80 years of age
- Diagnosis of rheumatoid arthritis
- Minimum of limited working proficiency in English
- No significant cognitive impairment that can inhibit their ability to engage in the study
Key exclusion criteria (4 listed)
- Age less than 18 years or greater than 80 years
- Significant cognitive impairment that impedes ability to engage in the study
- Unwilling to participate in the study
- Patients currently pregnant will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care Rheumatology Family Physician ConsultationThe participant will be booked with a primary care rheumatology family physician for rheumatoid arthritis comorbidity screening. They will complete weight, height, blood pressure measurement, assess for risk factors for dyslipidemia, type 2 diabetes, hypertension, bone mineral density loss and vaccine preventable infectious diseases. | Other | Comprehensive Comorbidity Clinic |
Primary outcome
Care Gap: Pneumococcal vaccination
Time frame: 6 months
the number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and addressed within 6 months of comorbidity clinic intervention, for pneumococcal vaccination.
Care Gap: Cardiovascular screening
Time frame: 6 months
the number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) identified and addressed within 6 months of comorbidity clinic intervention, for cardiovascular screening (determined by meeting a combination of blood pressure, cholesterol and blood sugar measurement guidelines)
Care Gap: Osteoporosis screening
Time frame: 6 months
The number of care gaps (percentage of individuals who require treatment according to established guidelines, but do not receive it) for osteoporosis prevention and screening (determined by meeting guidelines for Vitamin D supplementation and bone densitometry completion)
2 secondary outcomes
Care Gap: vaccine-preventable diseases (herpes zoster, influenza and COVID-19)
Time frame: 6 months
Care Gap: Comorbidity treatment with medication
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cassandra Schulz principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Rheumatology Family Physician Consultation in people with Rheumatoid Arthritis and Comorbidities and Coexisting Conditions, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Schulz, MD ((519) 279-4047, wrheumatologystudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Gap: Pneumococcal vaccination (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.