N/A
N=238
Personalized Risk Estimator for Rheumatoid Arthritis Family Study
First Degree Relatives of Rheumatoid Arthritis Patients
Bottom Line
View on ClinicalTrials.gov: NCT02046005 ↗Enrolled (actual)
238
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Contemplation Ladder — 40; 46; 43; 41 Participants — p=0.043
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRE-RA (Behavioral); PRE-RA Plus (Behavioral); General Rheumatoid Arthritis Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contemplation Ladder |
40; 46; 43; 41; 49; 45 | 0.043 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02046005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.