Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Axial Spondyloarthritis
- Crohn Disease
- Hidradenitis Suppurativa
- Psoriasis
- Psoriatic Arthritis
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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....
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.
Tracking Information
- NCT #
- NCT04200690
- Collaborators
- Aarhus University Hospital
- Investigators
- Principal Investigator: Kasper F Hjuler, MD PhD Aarhus University Hospital Study Chair: Lars Iversen, MD PhD DMSc University of Aarhus