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

Mayo Clinic178 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

178

Conditions

Rheumatoid Arthritis

Interventions

FLARE Intervention GroupOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Anticipated length of study is two years.

Flare-to-visit Time

The flare-to-visit time will be compared between the two groups.

Time frame: Anticipated length of study is two years.

Secondary Outcomes

Participant Satisfaction

Satisfaction surveys will be provided to participants at three time-points: baseline, year one, and end of study.

Time frame: Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.

Data from ClinicalTrials.gov

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