First Degree Relatives of Rheumatoid Arthritis Patients Clinical Trial
— PRE-RAOfficial title:
Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives
Verified date | July 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 238 |
Est. completion date | July 2018 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |