NCT02351401

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 12, 2015

Last Update Submit

January 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence-adjusted bias adjusted kappa, PABAK>0.6

    at 6 months

Secondary Outcomes (3)

  • Bland and Altman 95% limits of agreement

    6 months

  • Level of satisfaction

    6 months

  • disease activity score in 28 joints (DAS28)

    6 months

Study Arms (2)

Education with ultrasonography

EXPERIMENTAL

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

Behavioral: Education using ultrasonography as feedback tool

Standard Care

NO INTERVENTION

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

Interventions

Education using ultrasonography as feedback tool

Education with ultrasonography

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Peter Cheung

    National University Hospital, Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Peter Cheung

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 30, 2015

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

October 1, 2013

Last Updated

January 30, 2015

Record last verified: 2015-01