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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046005
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 7, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Elizabeth Karlson, M.D., Brigham and Women's Hospital

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Elizabeth W Karlson, MD Brigham and Women's Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Karlson, M.D., Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02046005    
Other Study ID Numbers: P60 AR047782-6121
P60AR047782 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2014    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Elizabeth Karlson, M.D., Brigham and Women's Hospital:
Family History
RA
Rheumatoid Arthritis
Genetics
Rheumatoid Factor
Shared Epitope
Anti-CCP
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases