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Rheumatoid Arthritis Through Education and US Study (RAEUS) (RAEUS)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education using ultrasonography as feedback tool
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • RA patients fulfilling ACR1987 criteria
  • adults between age 21 and 80 years

Exclusion Criteria:

  • pregnant
  • no mental health illness
  • fit to perform informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Education with ultrasonography

    Standard Care

    Arm Description

    Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool

    Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool

    Outcomes

    Primary Outcome Measures

    prevalence-adjusted bias adjusted kappa, PABAK>0.6

    Secondary Outcome Measures

    Bland and Altman 95% limits of agreement
    swollen joint count agreement
    Level of satisfaction
    Likert response, satisfaction survey
    disease activity score in 28 joints (DAS28)
    composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment

    Full Information

    First Posted
    January 12, 2015
    Last Updated
    January 27, 2015
    Sponsor
    National University Hospital, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02351401
    Brief Title
    Rheumatoid Arthritis Through Education and US Study (RAEUS)
    Acronym
    RAEUS
    Official Title
    Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National University Hospital, Singapore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on the ability of patients to assess for clinical synovitis swollen joints in RA.
    Detailed Description
    Design: 6-month single centre randomized controlled trial. Patients: established RA. Intervention: education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3 months versus standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa, PABAK>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education with ultrasonography
    Arm Type
    Experimental
    Arm Description
    Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education using ultrasonography as feedback tool
    Intervention Description
    Education using ultrasonography as feedback tool
    Primary Outcome Measure Information:
    Title
    prevalence-adjusted bias adjusted kappa, PABAK>0.6
    Time Frame
    at 6 months
    Secondary Outcome Measure Information:
    Title
    Bland and Altman 95% limits of agreement
    Description
    swollen joint count agreement
    Time Frame
    6 months
    Title
    Level of satisfaction
    Description
    Likert response, satisfaction survey
    Time Frame
    6 months
    Title
    disease activity score in 28 joints (DAS28)
    Description
    composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: RA patients fulfilling ACR1987 criteria adults between age 21 and 80 years Exclusion Criteria: pregnant no mental health illness fit to perform informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Cheung
    Organizational Affiliation
    National University Hospital, Rheumatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25477057
    Citation
    Cheung PP, Lahiri M, Teng GG, Lim AY, Lau TC, Lateef A, Mak A, Gossec L, March L. A randomized controlled trial for improving patient self-assessment of synovitis in rheumatoid arthritis with education by ultrasonography: the RAEUS Study. Rheumatology (Oxford). 2015 Jul;54(7):1161-9. doi: 10.1093/rheumatology/keu447. Epub 2014 Dec 3.
    Results Reference
    derived

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    Rheumatoid Arthritis Through Education and US Study (RAEUS)

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