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

September 2, 2020 updated by: John M. Davis, III, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flare Occurrence
Time Frame: Anticipated length of study is two years.
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.
Flare-to-visit Time
Time Frame: Anticipated length of study is two years.
The flare-to-visit time will be compared between the two groups.
Anticipated length of study is two years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction
Time Frame: Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Pfizer

Investigators

  • Principal Investigator: Eric L Matteson, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-008535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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