Clinical trial NCT02046005: Personalized Risk Estimator for Rheumatoid Arthritis Family Study
Official title: Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Degree Relatives of Rheumatoid Arthritis Patients
Keywords: Family History
RA
Rheumatoid Arthritis
Genetics
Rheumatoid Factor
Shared Epitope
Anti-CCP
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2014-01-27
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contemplation Ladder
timeFrame: Immediately, 6 weeks, and 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth W Karlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Prado MG, Iversen MD, Yu Z, Miller Kroouze R, Triedman NA, Kalia SS, Lu B, Green RC, Karlson EW, Sparks JA. Effectiveness of a Web-Based Personalized Rheumatoid Arthritis Risk Tool With or Without a Health Educator for Knowledge of Rheumatoid Arthritis Risk Factors. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1421-1430. doi: 10.1002/acr.23510.