Clinical trial NCT04200690: Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Psoriatic Arthritis
Axial Spondyloarthritis
Hidradenitis Suppurativa
Crohn Disease
Ulcerative Colitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-12-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
timeFrame: 24 Weeks
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Proportion of subjects achieving Minimal Clinical Important Difference (MCID) on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
timeFrame: 24 Weeks
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: Week 24
measure: Change from baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI:GH) Percentage of Overall Work Impairment
timeFrame: Week 24
measure: Change in mean General Self-Efficacy scale scores
timeFrame: Week 24
measure: Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
timeFrame: Week 24
measure: Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-D)
timeFrame: Week 24
Other outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: 24 and 48 Weeks
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI)
timeFrame: 24 and 48 Weeks
measure: Change in the mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 24 and 48 Weeks
measure: Change from baseline in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
timeFrame: 24 and 48 Weeks
measure: Change from baseline in body weight
timeFrame: 24 and 48 Weeks
measure: Change from baseline in blood lipid levels
timeFrame: 24 Weeks
measure: Improvement in Psoriasis Area and Severity Index (PASI)
timeFrame: 24 Weeks
measure: The proportion of participants who achieve ASDAS remission (remission <1.3 / not in ASDAS remission >1.3) based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) measure
timeFrame: 24 Weeks
measure: The proportion of participants who achieve an ASAS 20 / 40 response (Assessment of SpondyloArthritis International Society criteria)
timeFrame: 24 Weeks
measure: Percentage of Participants With an ACR 20/40 Response
timeFrame: 24 Weeks
measure: Percentage of patients achieving clinical response based on Harvey-Bradshaw Index (HBI)
timeFrame: 24 Weeks
measure: Percentage of Participants achieving a clinical response <=2 based on the Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: 24 Weeks
measure: Proportion of patients with Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: 24 Weeks
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
timeFrame: 48 Weeks
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
timeFrame: 48 Weeks
measure: Change in mean General Self-Efficacy scale scores
timeFrame: 48 Weeks
measure: Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-D)
timeFrame: 48 Weeks
measure: Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
timeFrame: 48 Weeks
measure: Change from baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI:GH) Percentage of Overall Work Impairment
timeFrame: 48 Weeks
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: 48 Weeks
Locations:
city: Aarhus
country: Denmark
facility: National Center for Autoimmune Diseases, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Kasper F Hjuler, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Lars Iversen, MD PhD DMSc
role: STUDY_CHAIR
References:
citation: Hjuler KF, Dige A, Agnholt J, Laurberg TB, Loft AG, Moller LF, Christensen R, Iversen L. 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 randomised trial. BMJ Open. 2021 Apr 28;11(4):e041871. doi: 10.1136/bmjopen-2020-041871.