Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Flare Occurrence
研究概览
简要总结
The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: FLARE Intervention Group (Other)
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.
结局指标
主要结局
Flare Occurrence
时间窗: 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
时间窗: Anticipated length of study is two years.
The flare-to-visit time will be compared between the two groups.
次要结局
- Participant Satisfaction(Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.)
研究者
John M. Davis, III
Principal Investigator
Mayo Clinic