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

Mayo Clinic

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: FLARE Intervention Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02382783

14-008535

Details and patient eligibility

About

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

Full 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).

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

FLARE Intervention Group

Other group

Description:

In the FLARE Intervention Group, we ask that you participate in all of the following, over the course of two years: * Baseline Study Visit * Monthly: Complete FLARE Questionnaires, at home, and report results. The last question on this questionnaire will ask you if you feel you are having a flare of your disease. * FLARE Study Visit (if applicable): We will schedule you to be seen when/if you feel you are having a flare of your disease. * Follow-up Visits (minimum of every 6 months): These are done as the standard of care for your RA. * At one time-point, during your first return visit after the baseline visit you will have an examination by ultrasound * Patient Satisfaction Surveys at three time-points: Baseline, 1 year, 2 year Also, your rheumatology health care provider (RHCP) will be asked to participate in the study by completing three satisfaction surveys over the course of two years.

Treatment:

Other: FLARE Intervention Group

Standard of Care (SOC) Group

No Intervention group

Description:

If you are randomized to the SOC Group, your care will not be any different than your usual care of rheumatoid arthritis (RA). You will be seen by a rheumatologist at a minimum of every six months, which is the standard of care for RA. Additionally (for research), we ask the following of you... * At one time-point, during your first return visit after the baseline visit you will have an examination by ultrasound * Patient Satisfaction Surveys at three time-points: Baseline, 1 year, 2 year Also, your rheumatology health care provider (RHCP) will be asked to participate in the study by completing three satisfaction surveys over the course of two years.