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Completed

NCT Number: NCT02351401

Rheumatoid Arthritis Through Education and US Study (RAEUS)

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education using ultrasonography as feedback tool

Behavioral

Education using ultrasonography as feedback tool

Primary outcomes

  1. prevalence-adjusted bias adjusted kappa, PABAK>0.6

    Time frame: at 6 months

Secondary outcomes

  1. Bland and Altman 95% limits of agreement

    Time frame: 6 months

    swollen joint count agreement

  2. Level of satisfaction

    Time frame: 6 months

    Likert response, satisfaction survey

  3. disease activity score in 28 joints (DAS28)

    Time frame: 6 months

    composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)

Acronym: RAEUS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 30, 2015
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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