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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04200690
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Aarhus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kasper F Hjuler, MD PhDLars Iversen, MD PhD DMSc
Principal Investigator Affiliation Aarhus University HospitalUniversity of Aarhus
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Hidradenitis Suppurativa, Crohn Disease, Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Interdisciplinary management

Interdisciplinary combined clinical care

Active Comparator: Usual-care management

Usual-care

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aarhus, Denmark

Status

Recruiting

Address

National Center for Autoimmune Diseases, Aarhus University Hospital

Aarhus, , 8200

Site Contact

Kasper F Hjuler, MD, PhD

kasped@rm.dk

+4523882479

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