Personalized Risk Estimator for Rheumatoid Arthritis Family Study
| Status: | Completed |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 8/10/2018 |
| Start Date: | January 2014 |
| End Date: | July 2018 |
Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives
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.
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.
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.
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.
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
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