Personalized Risk Estimator for Rheumatoid Arthritis Family Study

First Degree Relatives of Rheumatoid Arthritis Patients Clinical Trial

— PRE-RA  

Official title:

Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046005
• Other study ID #: P60 AR047782-6121
• Secondary ID: P60AR047782
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: July 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• First Degree Relatives of Rheumatoid Arthritis Patients

Intervention

Behavioral:
• 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.
• 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.
• General Rheumatoid Arthritis Education
Participants will receive general information about signs and symptoms of rheumatoid arthritis.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately, 6 weeks, and 6 months after intervention