Optimizing the Management of Flares in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382783
• Other study ID #: 14-008535
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).

Description:

This project is aimed at developing an improved multilevel care process model for the management of rheumatoid arthritis (RA) disease activity by implementing systematic self-monitoring of flare experiences by RA patients, combined with continuous patient-tailored adjustments of treatment modalities by a coordinated team of rheumatology health care providers (RHCPs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 1, 2020
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patient must be = 18 years of age.

• Patient must have been seen by a rheumatology health care provider at least two times within the last 18 months at Mayo Clinic Rochester.

• Patient must have rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.

• Patient must have the ability to understand and the willingness to sign a written informed consent document.

• Patient must be willing to return to Mayo Clinic Rochester for follow-up appointments and fill out questionnaires as outlined in the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• FLARE Intervention Group
Everything being completed in this group is also being completed in the Standard of Care (SOC) Group except for the following... The participants randomized to this group will be asked to complete FLARE Questionnaires on a monthly basis and will call us each month with their results. The last question on the questionnaire asks if the patient feels he/she is having a flare. If the patient says "yes" to this question, then the study coordinator will arrange for an appointment to be scheduled with a rheumatology health care provider at Mayo Clinic Rochester. The goal will be to have this appointment take place within seven days of the FLARE Questionnaire results being reported.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bingham CO 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, Witter JP, Furst DE, Strand CV, Boers M, Alten RE. Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group). J Rheumatol. 2009 Oct;36(10):2335-41. doi: 10.3899/jrheum.090369. Epub 2009 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flare Occurrence	The occurrence of flares over the follow-up time (flare rate). The Outcome Measures in Rheumatology(OMERACT-9) definition of flare will be applied to both groups to determine how many occurrences indicate worsening of disease activity, leading to initiation, change, or increase of therapy by RHCPs. This definition will allow for parallel comparisons of flare rates in both groups.	Anticipated length of study is two years.
Primary	Flare-to-visit Time	The flare-to-visit time will be compared between the two groups.	Anticipated length of study is two years.
Secondary	Participant Satisfaction	Satisfaction surveys will be provided to participants at three time-points: baseline, year one, and end of study.	Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.

External Links

•   Mayo Clinic Clinical Trials