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Multidisciplinary Team Care in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03099668
Recruitment Status : Unknown
Verified March 2017 by National University Hospital, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Centre for Health Services and Policy Research
Information provided by (Responsible Party):
National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Multidisciplinary Communication Other: Visit to a multidisciplinary clinic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 parallel gruop allocation to multidisciplinary vs routine care
Masking: Single (Outcomes Assessor)
Masking Description: Joint counts at 3 and 6 months will be done by a blinded investigator
Primary Purpose: Health Services Research
Official Title: The Multidisciplinary Team: Truly Beneficial or Just the Flavour of the Day?A Randomized Controlled Study to Study Outcomes From MDT Care in Rheumatoid Arthritis
Actual Study Start Date : November 17, 2016
Estimated Primary Completion Date : May 24, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OSAC
Single visit to a multidisciplinary clinic (the One Stop Arthritis Clinic, OSAC), followed by routine care
Other: Visit to a multidisciplinary clinic
Visit to a multidisciplinary clinic

No Intervention: Routine care
Routine care



Primary Outcome Measures :
  1. European Quality of Life-5 Dimension 3 Level (EQ-5D) index at 6 months [ Time Frame: 6 months ]
    Quality of life


Secondary Outcome Measures :
  1. 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) [ Time Frame: 6 months ]
    Disease activity

  2. Pain (measured using a 100mm visual analogue (VAS) scale [ Time Frame: 3 months ]
    Pain

  3. Physical function (measured using the modified Health Assessment Questionnaire, mHAQ). [ Time Frame: 6 months ]
    Physical function (patient reported outcome)

  4. Self-efficacy (measured using the Rheumatoid Arthritis Self Efficacy, RASE) [ Time Frame: 3 months ]
    Self Efficacy

  5. Disease Specific Knowledge (DSK) using a Patient Knowledge Questionnaire (PKC) [ Time Frame: 3 months ]
    Disease specific knowledge

  6. Coping - measured using a 100mm visual analogue scale answer to a single question "Considering your arthritis overall, how well did you cope (manage, deal, make do) with your disease during the last week ?" [ Time Frame: 3 months ]
    Coping

  7. Medication adherence (using the MARS questionnaire and pill count to calculate medication adherence proportion percentage) [ Time Frame: 3 months ]
    Medication adherence

  8. Patient experience (using the standard hospital electronic patient experience survey, e-PES) [ Time Frame: 3 months ]
    patient experience

  9. Foot pain (using the Manchester foot disability index, MFI) [ Time Frame: 3 months ]
    Foot pain

  10. Proportion of patients who achieve adherence to guidelines for vaccination [ Time Frame: 6 months ]
    vaccination

  11. Proportion of patients who achieve adherence to guidelines for cardiovascular risk management [ Time Frame: 6 months ]
    Cardiovascular risk assessment

  12. Proportion of patients who achieve adherence to guidelines for bone health optimisation [ Time Frame: 6 months ]
    Bone health

  13. Proportion of patients who achieve adherence to guidelines for cancer screening [ Time Frame: 6 months ]
    Cancer screening

  14. Utilisation of healthcare resources (clinic visits, laboratory, imaging, procedures, prescriptions, calls to the nurse helpline) measured as total dollar cost (from the hospital perspective) [ Time Frame: 6 months ]
    Utilisation of resources

  15. Days off work (patient) [ Time Frame: 6 months ]
    Days off

  16. Days off work (caregiver) [ Time Frame: 6 months ]
    Days off for carer

  17. Hours per week in productive paid or unpaid work (patient) [ Time Frame: 6 months ]
    Working hours

  18. Hours per week in productive paid or unpaid work (caregiver) [ Time Frame: 6 months ]
    working hours (carer)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099668


Locations
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Singapore
Rheumatology outpatient clinic, National University Hospital
Singapore, Sinagpore, Singapore, 119228
Sponsors and Collaborators
National University Hospital, Singapore
Centre for Health Services and Policy Research
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03099668    
Other Study ID Numbers: 2016/00848
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases