Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment flare intervention group
Sponsor Mayo Clinic
Collaborator Pfizer
Start date March 2015
End date February 2017
Trial size 178 participants
Trial identifier NCT02382783, 14-008535

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Other)
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.
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)
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.

Primary Outcomes

Measure
Flare Occurrence
time frame: Anticipated length of study is two years.
Flare-to-visit Time
time frame: Anticipated length of study is two years.

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
Principal investigator Eric L Matteson, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.