NCT04200690

Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases

Effectiveness of Interdisciplinary Combined Dermatology-Gastroenterology-Rheumatology Clinical Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases: A Parallel Group, Non-blinded, Pragmatic Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 specialized 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 (anticipated) will be randomized to either multidisciplinary combined clinic intervention (200 subjects, anticipated) or usual care (100 subjects, anticipated). The study will consist of a 24-Week active intervention period and an additional 24-Weeks follow-up period.

Conditions

• Psoriasis
• Psoriatic Arthritis
• Axial Spondyloarthritis
• Hidradenitis Suppurativa
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Interdisciplinary management	The intervention in this trial consists of the combined efforts of the interdisciplinary team in the combined clinic arm. The interdisciplinary team consists of dermatologists, gastroenterologists, rheumatologists, nurses, psychologists, dieticians, social workers, physiotherapists, and secretaries. Treatment will be individualized based on clinical, biomarker, phenotypic, and psychosocial characteristics. The medical treatment will follow local, national and international guidelines.
OTHER	Usual-care management	Usual care will be carried out by HCPs that are not otherwise involved in the trial. In usual care the patients will not be offered an interdisciplinary patient-centered care as described, but only attend their usual disease-specific departments at the usual appointments.Treatment will be prescribed as felt appropriate according to local, national and international guidelines by the treating physicians with no set protocol and no restrictions.

Timeline

• Start date: 2020-01-14
• Primary completion: 2023-01-31
• Completion: 2024-01-31
• First posted: 2019-12-16
• Last updated: 2023-06-02

Locations

1 site across 1 country: Denmark