Personalized Risk Estimator for Rheumatoid Arthritis Family Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives

Conditions
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First Degree Relatives of Rheumatoid Arthritis Patients

Intervention / Treatment
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* Behavioral: PRE-RA
* Behavioral: PRE-RA Plus
* Behavioral: General Rheumatoid Arthritis Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First degree blood relative (parent, sibling, or child) with diagnosis of RA Age between 18 and 70 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Rheumatoid Arthritis Education<br>Arm 1 participants will receive general information about RA. | Behavioral: General Rheumatoid Arthritis Education<br>* Participants will receive general information about signs and symptoms of rheumatoid arthritis.<br>|
| Experimental: PRE-RA<br>Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. | Behavioral: PRE-RA<br>* 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.<br>* Other names: Personalized Risk Estimator for RA;|
| Experimental: PRE-RA Plus<br>Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. | Behavioral: PRE-RA Plus<br>* 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.<br>* Other names: Personalized Risk Estimator for RA with Health Educator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contemplation Ladder | 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. | Immediately, 6 weeks, and 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, Family History, Rheumatoid Arthritis, Genetics, Rheumatoid Factor, Shared Epitope, Anti-CCP