Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02046005
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Personalized Risk Estimator for Rheumatoid Arthritis Family Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ekarlson@bwh.harvard.edu', 'phone': '617-732-5078', 'title': 'Dr. Elizabeth Karlson', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Behavioral intervention', 'eventGroups': [{'id': 'EG000', 'title': 'General Rheumatoid Arthritis Education', 'description': 'Arm 1 participants will receive general information about RA.\n\nGeneral Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PRE-RA', 'description': 'Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.\n\nPRE-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.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PRE-RA Plus', 'description': 'Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.\n\nPRE-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.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contemplation Ladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'General Rheumatoid Arthritis Education', 'description': 'Arm 1 participants will receive general information about RA.\n\nGeneral Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.'}, {'id': 'OG001', 'title': 'PRE-RA', 'description': 'Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.\n\nPRE-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.'}, {'id': 'OG002', 'title': 'PRE-RA Plus', 'description': 'Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.\n\nPRE-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.'}], 'classes': [{'title': 'Immediately post-intervention', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': '6 weeks post-intervention', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': '6 months post-intervention', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.51', 'pValueComment': 'We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).', 'estimateComment': 'PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)', 'groupDescription': 'In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single "PRE-RA group" and compared it to the Comparison arm (aka "General Rheumatoid Arthritis Education")', 'statisticalMethod': 'generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately, 6 weeks, and 6 months after intervention', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'General Rheumatoid Arthritis Education', 'description': 'Arm 1 participants will receive general information about RA.\n\nGeneral Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.'}, {'id': 'FG001', 'title': 'PRE-RA', 'description': 'Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.\n\nPRE-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.'}, {'id': 'FG002', 'title': 'PRE-RA Plus', 'description': 'Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.\n\nPRE-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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'General Rheumatoid Arthritis Education', 'description': 'Arm 1 participants will receive general information about RA.\n\nGeneral Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.'}, {'id': 'BG001', 'title': 'PRE-RA', 'description': 'Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.\n\nPRE-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.'}, {'id': 'BG002', 'title': 'PRE-RA Plus', 'description': 'Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.\n\nPRE-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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '45.6', 'spread': '14.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}, {'title': 'Non-White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2014-01-23', 'resultsFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2014-01-23', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-08', 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contemplation Ladder', 'timeFrame': 'Immediately, 6 weeks, and 6 months after intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Family History', 'RA', 'Rheumatoid Arthritis', 'Genetics', 'Rheumatoid Factor', 'Shared Epitope', 'Anti-CCP'], 'conditions': ['First Degree Relatives of Rheumatoid Arthritis Patients']}, 'referencesModule': {'references': [{'pmid': '25151341', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29024454', 'type': 'RESULT', '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 Using Genetics, Biomarkers, and Lifestyle Factors to Motivate Health Behavior Improvements: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Jun;70(6):823-833. doi: 10.1002/acr.23411. Epub 2018 Apr 16.'}, {'pmid': '29316383', 'type': 'DERIVED', 'citation': 'Prado MG, Iversen MD, Yu Z, Miller Kroouze R, Triedman NA, Kalia SS, Lu B, Green RC, Karlson EW, Sparks JA. Effectiveness of a Web-Based Personalized Rheumatoid Arthritis Risk Tool With or Without a Health Educator for Knowledge of Rheumatoid Arthritis Risk Factors. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1421-1430. doi: 10.1002/acr.23510.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First degree blood relative (parent, sibling, or child) with diagnosis of RA\n* Age between 18 and 70 years old\n\nExclusion Criteria:\n\n* Non-English speaking\n* Sign/symptoms of rheumatoid arthritis (assessed by screening questionnaire and study staff)\n* Rheumatoid arthritis\n* Systemic lupus erythematosus\n* Juvenile Idiopathic Arthritis\n* Psoriatic Arthritis\n* Ankylosing Spondylitis\n* Mixed Connective Tissue Disease\n* Reactive Arthritis\n* Adult-Onset Still's Disease\n* Sjogren's Syndrome\n* Dermatomyositis\n* Polymyositis\n* Polymyalgia Rheumatica\n* ANCA-associated Vasculitis\n* Giant Cell Arteritis\n* Polyarteritis Nodosa\n* Behcet's Disease\n* Relapsing Polychondritis"}, 'identificationModule': {'nctId': 'NCT02046005', 'acronym': 'PRE-RA', 'briefTitle': 'Personalized Risk Estimator for Rheumatoid Arthritis Family Study', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives', 'orgStudyIdInfo': {'id': 'P60 AR047782-6121'}, 'secondaryIdInfos': [{'id': 'P60AR047782', 'link': 'https://reporter.nih.gov/quickSearch/P60AR047782', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General Rheumatoid Arthritis Education', 'description': 'Arm 1 participants will receive general information about RA.', 'interventionNames': ['Behavioral: General Rheumatoid Arthritis Education']}, {'type': 'EXPERIMENTAL', 'label': 'PRE-RA', 'description': 'Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool.', 'interventionNames': ['Behavioral: PRE-RA']}, {'type': 'EXPERIMENTAL', 'label': 'PRE-RA Plus', 'description': 'Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator.', 'interventionNames': ['Behavioral: PRE-RA Plus']}], 'interventions': [{'name': 'PRE-RA', 'type': 'BEHAVIORAL', 'otherNames': ['Personalized Risk Estimator for RA'], 'description': '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.', 'armGroupLabels': ['PRE-RA']}, {'name': 'PRE-RA Plus', 'type': 'BEHAVIORAL', 'otherNames': ['Personalized Risk Estimator for RA with Health Educator'], 'description': '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.', 'armGroupLabels': ['PRE-RA Plus']}, {'name': 'General Rheumatoid Arthritis Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive general information about signs and symptoms of rheumatoid arthritis.', 'armGroupLabels': ['General Rheumatoid Arthritis Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elizabeth W Karlson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Elizabeth Karlson, M.D.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}