CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 238 enrolled
Drug / intervention
PRE-RA +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02046005
NCT02046005N/ACompleted
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Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives

Brigham and Women's Hospital·interventional·Posted Jan 27, 2014·Updated Aug 8, 2018

In Brief

A clinical study evaluating PRE-RA, PRE-RA Plus, and 1 other intervention for First Degree Relatives of Rheumatoid Arthritis Patients. Completed, enrolled 238 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFirst Degree Relatives of Rheumatoid Arthritis Patients
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2016
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.4 years ago

Interventions

PRE-RAbehavioral

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 Plusbehavioral

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 Educationbehavioral

Participants will receive general information about signs and symptoms of rheumatoid arthritis.