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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FLARE Intervention Group

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Disease Activity, Flare, Management of Flares, Pfizer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

FLARE Intervention Group

Standard of Care (SOC) Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Flare-to-visit Time

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

Secondary Outcome Measures

Participant Satisfaction

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

Full Information

NCT ID

NCT02382783

First Posted

February 23, 2015

Last Updated

September 2, 2020

Sponsor

Mayo Clinic

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02382783

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Disease Activity, Flare, Management of Flares, Pfizer

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLARE Intervention Group

Arm Type

Other

Arm 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.

Arm Title

Standard of Care (SOC) Group

Arm Type

No Intervention

Arm 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.

Intervention Type

Other

Intervention Name(s)

FLARE Intervention Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Flare Occurrence

Description

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.

Title

Flare-to-visit Time

Description

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

Time Frame

Anticipated length of study is two years.

Secondary Outcome Measure Information:

Title

Participant Satisfaction

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric L Matteson, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19684147

Citation

Bingham CO 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, Witter JP, Furst DE, Strand CV, Boers M, Alten RE. Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group). J Rheumatol. 2009 Oct;36(10):2335-41. doi: 10.3899/jrheum.090369. Epub 2009 Aug 14.

Results Reference

background

PubMed Identifier

31264032

Citation

Myasoedova E, Crowson CS, Giblon RE, McCarthy-Fruin K, Schaffer DE, Wright K, Matteson EL, Davis JM 3rd. Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial. Clin Rheumatol. 2019 Nov;38(11):3025-3032. doi: 10.1007/s10067-019-04664-5. Epub 2019 Jul 1.

Results Reference

derived

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial