Personalized Risk Estimator for Rheumatoid Arthritis Family Study (PRE-RA)
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|ClinicalTrials.gov Identifier: NCT02046005|
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 7, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|First Degree Relatives of Rheumatoid Arthritis Patients||Behavioral: PRE-RA Behavioral: PRE-RA Plus Behavioral: General Rheumatoid Arthritis Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||July 2018|
Active Comparator: General Rheumatoid Arthritis Education
Arm 1 participants will receive general information about RA.
Behavioral: General Rheumatoid Arthritis Education
Participants will receive general information about signs and symptoms of rheumatoid arthritis.
Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.
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.
Other Name: Personalized Risk Estimator for RA
Experimental: PRE-RA Plus
Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.
Behavioral: 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.
Other Name: Personalized Risk Estimator for RA with Health Educator
- Contemplation Ladder [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046005
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Elizabeth W Karlson, MD||Brigham and Women's Hospital|