Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases (NCAS-1)

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    300
  • sponsor
    University of Aarhus
Updated on 1 March 2022
psoriasis
mediators
imid

Summary

The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with two or more Immune-mediated inflammatory diseases (IMIDs).

Description

Immune-mediated inflammatory diseases (IMIDs) such as psoriasis, hidradenitis suppurative, spondyloarthritis, and inflammatory bowel disease, are associated with increased risk of somatic and psychiatric comorbidities as well as reduced socioeconomic status and a risk of further autoimmune diseases. The unmet needs in the care of patients with IMIDs are caused by a lack of patient-centricity in the usual unidisciplinary siloed approach to these diseases. The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with the IMIDs: psoriasis, hidradenitis suppurativa, spondyloarthritis, ulcerative colitis, and Crohn's disease. This trial is designed to determine if the interdisciplinary intervention works in a real-world setting and thus has several pragmatic elements. The hypotheses will be tested in a randomized, usual care controlled, parallel-group clinical trial. Consecutively enrolled subjects are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care in a hospital clinical setting. 300 subjects will be randomized to either multidisciplinary combined clinic intervention (200 subjects) or usual care (100 subjects). The study will consist of a 24-Week active intervention period and an additional 24-Weeks follow-up period.

Details
Condition Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Hidradenitis Suppurativa, Crohn Disease, Ulcerative Colitis
Treatment Interdisciplinary management, Usual-care management
Clinical Study IdentifierNCT04200690
SponsorUniversity of Aarhus
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent obtained from the subject prior to randomization
Age 18 and above
Diagnosis of at least two IMIDs _or diagnosis of one IMID and clinical suspicion_ of another IMID
including and limited to: Psoriasis, HS, UC, CD, axSpA, PsA substantiated by e.g. clinical findings, imaging, biochemical results or histological examination at the discretion of the investigator

Exclusion Criteria

Non-Danish speaking
Expected to be unable to comply with the study protocol
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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