Overview

This trial is active, not recruiting.

Condition first degree relatives of rheumatoid arthritis patients
Treatments pre-ra, pre-ra plus, general rheumatoid arthritis education
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date January 2014
End date September 2016
Trial size 238 participants
Trial identifier NCT02046005, P60 AR047782-6121, P60AR047782

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
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.
(Experimental)
Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.
pre-ra Personalized Risk Estimator for 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.
(Experimental)
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 RA with Health Educator
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.

Primary Outcomes

Measure
Contemplation Ladder
time frame: Immediately, 6 weeks, and 6 months after intervention

Secondary Outcomes

Measure
Contemplation Ladder
time frame: 6 months after intervention
Contemplation Ladder
time frame: 6 weeks after intervention
Contemplation Ladder
time frame: Immediately after intervention
Contemplation Ladder
time frame: 12 months after intervention
Behavior Change
time frame: 6 months after intervention
Contemplation Ladder
time frame: Immediately, 6 weeks, and 6 months after intervention
Contemplation Ladder
time frame: Immediately, 6 weeks, and 6 months after intervention

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives
Principal investigator Elizabeth W Karlson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.