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| ID | Type | Description | Link |
|---|---|---|---|
| P60AR047782 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Rheumatoid Arthritis Education | Active Comparator | Arm 1 participants will receive general information about RA. |
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| PRE-RA | Experimental | Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. |
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| PRE-RA Plus | Experimental | Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRE-RA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth W Karlson, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25151341 | Background | 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. | |
| 29024454 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | PRE-RA |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Immediately, 6 weeks, and 6 months after intervention |
|
1 year
Behavioral intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Karlson | Brigham and Women's Hospital | 617-732-5078 | ekarlson@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| PRE-RA Plus | Behavioral | 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. |
|
|
| General Rheumatoid Arthritis Education | Behavioral | Participants will receive general information about signs and symptoms of rheumatoid arthritis. |
|
| 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. |
| 29316383 | Derived | 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. |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG002 | 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. |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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. | 0 | 78 | 0 | 78 | 0 | 78 |
| EG002 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |