NCT03099668

Brief Summary

A randomised study of multidisciplinary care (MDT) versus routine care in patients with rheumatoid arthritis (RA). Patients with RA are randomised either to a single visit to a "one Stop Arthritis Clinic' (OSAC) or to see their usual rheumatologists. Data are collected at the baseline visit, and again at subsequent clinic visits (approximately 3 and 6 months). Outcomes such as quality of life, disease activity, physical function, disease specific knowledge, coping and self efficacy are evaluated. Assessment of comorbidities and preventative care (cancer screening, vaccinations, cardiovascular risk assessment and optimisation) are also assessed between the 2 arms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

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 17, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

September 27, 2021

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 14, 2017

Last Update Submit

September 21, 2021

Conditions

Rheumatoid ArthritisMultidisciplinary Communication

Outcome Measures

Primary Outcomes (1)

  • European Quality of Life-5 Dimension 3 Level (EQ-5D) index at 6 months

    Quality of life

    6 months

Secondary Outcomes (19)

  • Proportion of patients in clinical remission or low RA disease activity (measured using the disease activity score in 28 joints, DAS28) (remission = DAS28 ≤ 2.6, low disease activity = DAS28 > 2.6 & ≤ 3.2)

    6 months

  • Pain (measured using a 100mm visual analogue (VAS) scale

    3 months

  • Physical function (measured using the modified Health Assessment Questionnaire, mHAQ).

    6 months

  • Self-efficacy (measured using the Rheumatoid Arthritis Self Efficacy, RASE)

    3 months

  • Disease Specific Knowledge (DSK) using a Patient Knowledge Questionnaire (PKC)

    3 months

  • +14 more secondary outcomes

Study Arms (2)

OSAC

EXPERIMENTAL

Single visit to a multidisciplinary clinic (the One Stop Arthritis Clinic, OSAC), followed by routine care

Other: Visit to a multidisciplinary clinic

Routine care

NO INTERVENTION

Routine care

Interventions

Visit to a multidisciplinary clinicOTHER

Visit to a multidisciplinary clinic

OSAC

Eligibility Criteria

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

You may qualify if:

  • Patients with rheumatoid arthritis, at least 21 years old, being seen at the rheumatology clinic at the National University Hospital, Singapore

You may not qualify if:

  • Patients who are pregnant, are unable to give informed consent, or have previously visited the One Stop Arthritis Clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology outpatient clinic, National University Hospital

Singapore, Sinagpore, 119228, Singapore

Location

Related Publications (1)

  • Lahiri M, Cheung PPM, Dhanasekaran P, Wong SR, Yap A, Tan DSH, Chong SH, Tan CH, Santosa A, Phan P. Evaluation of a multidisciplinary care model to improve quality of life in rheumatoid arthritis: a randomised controlled trial. Qual Life Res. 2022 Jun;31(6):1749-1759. doi: 10.1007/s11136-021-03029-3. Epub 2021 Nov 6.

    PMID: 34741249DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Joint counts at 3 and 6 months will be done by a blinded investigator
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1:1 parallel gruop allocation to multidisciplinary vs routine care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 4, 2017

Study Start

November 17, 2016

Primary Completion

May 17, 2018

Study Completion

February 28, 2019

Last Updated

September 27, 2021

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)