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

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ClinicalTrials.gov Identifier: NCT02382783
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
John M. Davis, III, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: FLARE Intervention Group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
Study Start Date : March 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382783


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Pfizer
Investigators
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Principal Investigator: Eric L Matteson, M.D. Mayo Clinic
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John M. Davis, III, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02382783    
Other Study ID Numbers: 14-008535
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Keywords provided by John M. Davis, III, Mayo Clinic:
Rheumatoid Arthritis
Disease Activity
Flare
Management of Flares
Pfizer
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases