Etiologies of Patient-Provider Discordance in Rheumatoid Arthritis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003798
About this study
The purpose of this study is to explicate factors contributing to inadequate improvement in physical function and health-related quality of life despite appropriate disease-modifying treatment in persons with rheumatoid arthritis (RA) and inflammatory arthritis (IA) who meet 2010 ACR/EULAR classification criteria for RA. To do this, this study focuses on the contract of discordance, whereby the patient judges her/his disease to be either more or less active than the rheumatologist. The positive impact of this award is anticipated to be the development of a clinical framework and approach to managing the various causes of inadequate clinical improvement, ultimately improving patient-physician communication and long-term patient-centered functional outcomes.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients must be of age ≥ 18 years.
- Patients must have a clinical diagnosis of IA or RA.
- Patients must fulfill the 2010 ACR/EULAR classification criteria for RA.
- Patients must reside within 150 miles of Mayo Clinic Rochester.
- Patients must have had 2 visits with a rheumatologist within the past 18 months.
- The most recent rheumatology visit must have been within 4 weeks of signing informed consent.
- Patients must fulfill criteria for enrollment into one of the following study groups:
- Discordant group (n = 50): ≥ 25-mm difference between the patient and provider global assessments of disease activity at the most recent clinical visit.
- Concordant low-disease-activity group (n = 10): < 25-mm difference between the patient and provider global assessments of disease activity AND clinical judgment of low disease activity or remission at the most recent rheumatology visit.
- Concordant high-disease-activity group (n = 10): < 25-mm difference between the patient and provider global assessments of disease activity AND clinical judgment of moderate-to-high disease activity at the most recent rheumatology visit.
Exclusion Criteria:
- Patients must be able and willing to participate in all study activities.
- Patients must be able to comprehend spoken and written English.
- Patients must not be members of a vulnerable population.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Davis, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available