Trial record 2 of 2007 for:    Rheumatoid Arthritis

Personalized Risk Estimator for Rheumatoid Arthritis Family Study (PRE-RA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth Karlson, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02046005
First received: January 23, 2014
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
First Degree Relatives of Rheumatoid Arthritis Patients
Behavioral: PRE-RA
Behavioral: PRE-RA Plus
Behavioral: General Rheumatoid Arthritis Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Contemplation Ladder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measures readiness to change behaviors


Secondary Outcome Measures:
  • Contemplation Ladder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures readiness to change behaviors

  • Contemplation Ladder [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measures readiness to change behaviors


Estimated Enrollment: 222
Study Start Date: January 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: PRE-RA
Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.
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.
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046005

Contacts
Contact: Nellie Triedman 617-732-6277 PRE-RAStudy@partners.org
Contact: Rachel Miller Kroouze, MA 617-525-8783 rkroouze@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Elizabeth W Karlson, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Elizabeth W Karlson, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Elizabeth Karlson, M.D., Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02046005     History of Changes
Other Study ID Numbers: P60 AR047782-6121, P60AR047782
Study First Received: January 23, 2014
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Family History
RA
Rheumatoid Arthritis
Genetics
Rheumatoid Factor
Shared Epitope
Anti-CCP

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 01, 2015