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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-07-01

Brief Summary

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

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Detailed Description

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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).

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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FLARE Intervention Group

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.

Group Type OTHER

FLARE Intervention Group

Intervention Type OTHER

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.

Standard of Care (SOC) Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No