Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases (NCAS-1)
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- STATUS
- Recruiting
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- End date
- Jan 30, 2023
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- participants needed
- 300
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- sponsor
- University of Aarhus
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 Identifier | NCT04200690 |
| Sponsor | University of Aarhus |
| Last Modified on | 1 March 2022 |
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