Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Contemplation Ladder
研究概览
简要总结
The purpose of this study is to understand how personalized risk factors for rheumatoid arthritis (RA) may impact willingness to change behaviors associated with RA. The investigators have developed a personalized risk estimator for RA based on demographics, family history, biomarkers and behaviors related to RA risk. Eligible participants have a first degree relative with RA but do not have RA themselves. Participants who meet eligibility and consent to the study will be randomized to receive either standard information about RA, the online personalized RA risk tool, or the online personalized RA risk tool with guidance from a health educator. Participants will be followed to measure willingness to change RA risk behaviors. The investigators hypothesize that participants who receive the online personalized RA risk tool and health education will be more willing to change RA risk behaviors compared to participants that receive standard RA information.
详细描述
A risk tool for rheumatoid arthritis (RA) was developed to provide personalized risk communication that includes biomarker, genetic and lifestyle RA risk factors. This risk calculator is referred to as the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) which will be used in the PRE-RA Family Study. A 3-arm randomized trial will be conducted among 222 RA first degree relatives that will be followed for one year. Participants will be surveyed before and after RA education concerning (i) knowledge and attitudes about RA risk, (ii) decisional balance related to behaviors, and (iii) stage of behavior change concerning lifestyle risks.
At the initial study visit, participants will be randomly assigned to one of three arms. Arm 1 participants will receive general education about RA (comparison group). These participants will be followed to assess for willingness to change behaviors associated with RA risk. Arm 2 participants will receive personalized risk by the personalized RA risk tool (PRE-RA). These participants will be followed to assess for willingness to change RA risk behaviors. Arm 3 participants will receive personalized risk by the online risk tool along with health education and counseling (PRE-RA Plus group). These participants will be followed to assess for willingness to change RA risk behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First degree blood relative (parent, sibling, or child) with diagnosis of RA
- •Age between 18 and 70 years old
排除标准
- •Non-English speaking
- •Sign/symptoms of rheumatoid arthritis (assessed by screening questionnaire and study staff)
- •Rheumatoid arthritis
- •Systemic lupus erythematosus
- •Juvenile Idiopathic Arthritis
- •Psoriatic Arthritis
- •Ankylosing Spondylitis
- •Mixed Connective Tissue Disease
- •Reactive Arthritis
- •Adult-Onset Still's Disease
- •Sjogren's Syndrome
- •Dermatomyositis
- •Polymyositis
- •Polymyalgia Rheumatica
- •ANCA-associated Vasculitis
- •Giant Cell Arteritis
- •Polyarteritis Nodosa
- •Behcet's Disease
- •Relapsing Polychondritis
研究组 & 干预措施
General Rheumatoid Arthritis Education
Arm 1 participants will receive general information about RA.
干预措施: General Rheumatoid Arthritis Education (Behavioral)
PRE-RA
Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.
干预措施: PRE-RA (Behavioral)
PRE-RA Plus
Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.
干预措施: PRE-RA Plus (Behavioral)
结局指标
主要结局
Contemplation Ladder
时间窗: Immediately, 6 weeks, and 6 months after intervention
Measures willingness to change any of 4 RA-related behaviors compared to baseline using generalized estimating equations to compare the PRE-RA groups to the comparison arm.
次要结局
未报告次要终点
研究者
Elizabeth Karlson, M.D.
Professor of Medicine
Brigham and Women's Hospital