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Trial record 1 of 1 for:    NCT02382783
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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

Tracking Information
First Submitted Date  ICMJE February 23, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date September 4, 2020
Study Start Date  ICMJE March 2015
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing the Management of Flares in Patients With Rheumatoid Arthritis (RA)
Official Title  ICMJE Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Other: FLARE Intervention Group
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
178
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02382783
Other Study ID Numbers  ICMJE 14-008535
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John M. Davis, III, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Eric L Matteson, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP