First Degree Relatives of Rheumatoid Arthritis Patients
Conditions
Keywords
Family History, RA, Rheumatoid Arthritis, Genetics, Rheumatoid Factor, Shared Epitope, Anti-CCP
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.
Interventions
BEHAVIORALPRE-RA
Personalized 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.
BEHAVIORALPRE-RA Plus
Personalized 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.
BEHAVIORALGeneral Rheumatoid Arthritis Education
Participants will receive general information about signs and symptoms of rheumatoid arthritis.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contemplation Ladder | Immediately, 6 weeks, and 6 months after intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Rheumatoid Arthritis Education Arm 1 participants will receive general information about RA.
General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis. | 80 |
| PRE-RA Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.
PRE-RA: Personalized 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. | 78 |
| PRE-RA Plus Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.
PRE-RA Plus: Personalized 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. | 80 |
| Total | 238 |
Baseline characteristics
| Characteristic | General Rheumatoid Arthritis Education | PRE-RA | PRE-RA Plus | Total |
|---|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 14.7 | 45.0 years STANDARD_DEVIATION 14.9 | 48.3 years STANDARD_DEVIATION 13.7 | 45.6 years STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized Non-White | 11 Participants | 13 Participants | 7 Participants | 31 Participants |
| Race/Ethnicity, Customized White | 69 Participants | 65 Participants | 73 Participants | 207 Participants |
| Sex: Female, Male Female | 63 Participants | 62 Participants | 57 Participants | 182 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 23 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 78 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 78 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 78 | 0 / 80 |
Outcome results
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.
Time frame: Immediately, 6 weeks, and 6 months after intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General Rheumatoid Arthritis Education | Contemplation Ladder | 6 weeks post-intervention | 41 Participants |
| General Rheumatoid Arthritis Education | Contemplation Ladder | Immediately post-intervention | 40 Participants |
| General Rheumatoid Arthritis Education | Contemplation Ladder | 6 months post-intervention | 40 Participants |
| PRE-RA | Contemplation Ladder | 6 weeks post-intervention | 49 Participants |
| PRE-RA | Contemplation Ladder | Immediately post-intervention | 46 Participants |
| PRE-RA | Contemplation Ladder | 6 months post-intervention | 53 Participants |
| PRE-RA Plus | Contemplation Ladder | Immediately post-intervention | 43 Participants |
| PRE-RA Plus | Contemplation Ladder | 6 months post-intervention | 48 Participants |
| PRE-RA Plus | Contemplation Ladder | 6 weeks post-intervention | 45 Participants |
Comparison: In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)p-value: 0.04395% CI: [1.01, 1.51]generalized estimating equations