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OpenTrials
Completed

NCT Number: NCT02382783

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FLARE Intervention Group

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Mar 9, 2015
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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