Personalized Risk Estimator for Rheumatoid Arthritis Family Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-07-31

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.

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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.

Conditions

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First Degree Relatives of Rheumatoid Arthritis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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General Rheumatoid Arthritis Education

Arm 1 participants will receive general information about RA.

Group Type ACTIVE_COMPARATOR

General Rheumatoid Arthritis Education

Intervention Type BEHAVIORAL

Participants will receive general information about signs and symptoms of rheumatoid arthritis.

PRE-RA

Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.

Group Type EXPERIMENTAL

PRE-RA

Intervention Type BEHAVIORAL

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.

PRE-RA Plus

Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.

Group Type EXPERIMENTAL

PRE-RA Plus

Intervention Type BEHAVIORAL

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.

Interventions

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PRE-RA

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.

Intervention Type BEHAVIORAL

PRE-RA Plus

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.

Intervention Type BEHAVIORAL

General Rheumatoid Arthritis Education

Participants will receive general information about signs and symptoms of rheumatoid arthritis.

Intervention Type BEHAVIORAL

Other Intervention Names

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Personalized Risk Estimator for RA Personalized Risk Estimator for RA with Health Educator

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes