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

University of Aarhus

Status: Active, not recruiting

Conditions: Psoriasis; Ulcerative Colitis; Axial Spondyloarthritis; Psoriatic Arthritis; Hidradenitis Suppurativa; Crohn Disease

Treatments: Other: Interdisciplinary management; Other: Usual-care management

Study type: Interventional

Funder types: Other

Identifiers

NCT04200690

NCAS-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent obtained from the subject prior to randomization.

2. Age 18 and above.

3. 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

1. Non-Danish speaking
2. Expected to be unable to comply with the study protocol

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Interdisciplinary management

Experimental group

Description:

Interdisciplinary combined clinical care

Treatment:

Other: Interdisciplinary management

Usual-care management

Active Comparator group

Description:

Usual-care

Treatment:

Other: Usual-care management