Comorbidity Management in Rheumatic Disease.

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Other: Primary Care Rheumatology Family Physician Consultation

• Study Type: Interventional
• Enrollment (Estimated): 199
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra Schulz, MD; Phone Number: (519) 279-4047; Email: wrheumatologystudy@gmail.com

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2T 0C2
      • Recruiting
      • Waterloo Rheumatology
      • Sub-Investigator: Yan Yeung, MD
      • Sub-Investigator: Sabrina Lue, MD
      • Contact: Cassandra Schulz, MD; Phone Number: (519) 279-4047; Email: wrheumatologystudy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Comprehensive Comorbidity Clinic; 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).

Other: Primary Care Rheumatology Family Physician Consultation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	6 months

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Canadian Rheumatology Association (CIORA)
• Investigators: Principal Investigator: Cassandra Schulz, Western University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; comorbidities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 125677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No