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NCT Number: NCT06579222

Comorbidity Management in Rheumatic Disease.

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Waterloo Rheumatology

Waterloo, Ontario, N2T 0C2, Canada

Location status: Recruiting

Location contact

Cassandra Schulz, MD

CONTACT

[email protected]

(519) 279-4047

Sabrina Lue, MD

SUB_INVESTIGATOR

Yan Yeung, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary Care Rheumatology Family Physician Consultation

Other

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

Secondary outcomes

  1. Care Gap: vaccine-preventable diseases (herpes zoster, influenza and COVID-19)

    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 managed for remaining vaccine-preventable diseases (herpes zoster, influenza and COVID-19).

  2. Care Gap: Comorbidity treatment with medication

    Time frame: 6 months

    (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Schulz, MD

CONTACT

[email protected]

(519) 279-4047

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • Canadian Rheumatology Association (CIORA)

Registry information

Official study title

Comorbidity Management in Rheumatic Disease: Assessing a Potential Care Gap in Patients With Rheumatoid Arthritis.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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