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First Degree Relatives of Rheumatoid Arthritis Patients | Personalized Risk Estimator for Rheumatoid Arthritis Family Study

First Degree Relatives of Rheumatoid Arthritis Patients research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

First Degree Relatives of Rheumatoid Arthritis Patients

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:PRE-RAPersonalized 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.

Behavioral:PRE-RA PlusPersonalized 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.

Behavioral:General Rheumatoid Arthritis EducationParticipants will receive general information about signs and symptoms of rheumatoid arthritis.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

General Rheumatoid Arthritis EducationArm 1 participants will receive general information about RA.

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

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

Study Status

Completed

Start Date: January 2014

Completed Date: July 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Contemplation Ladder

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Elizabeth W Karlson, MD

Lead Sponsor: Brigham and Women's Hospital

Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

More information:https://clinicaltrials.gov/show/NCT02046005

Sparks JA, Iversen MD, Miller Kroouze R, Mahmoud TG, Triedman NA, Kalia SS, Atkinson ML, Lu B, Deane KD, Costenbader KH, Green RC, Karlson EW. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives. Contemp Clin Trials. 2014 Sep;39(1):145-57. doi: 10.1016/j.cct.2014.08.007. Epub 2014 Aug 20.

Sparks JA, Iversen MD, Yu Z, Triedman NA, Prado MG, Miller Kroouze R, Kalia SS, Atkinson ML, Mody EA, Helfgott SM, Todd DJ, Dellaripa PF, Bermas BL, Costenbader KH, Deane KD, Lu B, Green RC, Karlson EW. Disclosure of Personalized Rheumatoid Arthritis Risk Using Genetics, Biomarkers, and Lifestyle Factors to Motivate Health Behavior Improvements: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Jun;70(6):823-833. doi: 10.1002/acr.23411. Epub 2018 Apr 16.

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