Personalized Risk Estimator for Rheumatoid Arthritis Family Study
Condition: First Degree Relatives of Rheumatoid Arthritis Patients
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PRE-RA; PRE-RA Plus; General Rheumatoid Arthritis Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information.; Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator.; Participants will receive general information about signs and symptoms of rheumatoid arthritis.
Other intervention name(s): Personalized Risk Estimator for RA; Personalized Risk Estimator for RA with Health Educator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Family History; RA; Rheumatoid Arthritis; Genetics; Rheumatoid Factor; Shared Epitope; Anti-CCP