Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Disease Activity, Flare, Management of Flares, Pfizer
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).
Interventions
OTHERFLARE 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.
Sponsors
Pfizer
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flare Occurrence | 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. |
| Flare-to-visit Time | Anticipated length of study is two years. | The flare-to-visit time will be compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction | 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. |
Countries
United States
Outcome results
None listed