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

Not Applicable

Active, not recruiting

• Conditions: Psoriasis; Psoriatic Arthritis; Ulcerative Colitis; Axial Spondyloarthritis; Hidradenitis Suppurativa; Crohn Disease
• Interventions: Other: Usual-care management; Other: Interdisciplinary management

• Registration Number: NCT04200690
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Study Start: 2020-01-14
• Primary Completion: 2023-01-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual-care management	Usual-care management	Usual-care
Interdisciplinary management	Interdisciplinary management	Interdisciplinary combined clinical care

Primary Outcome Measures

Name	Time	Method
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)	24 Weeks	SF-36 is a patient-reported outcome (PRO) measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)	24 Weeks	SF-36 is a patient-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

Secondary Outcome Measures

Name	Time	Method
Change in mean General Self-Efficacy scale scores	Week 24	The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score	Week 24	The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement.
Proportion of subjects achieving Minimal Clinical Important Difference (MCID) on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)	24 Weeks	SF-36 is a patient-reported outcome (PRO) measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-A)	Week 24	14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states.
Change from baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI:GH) Percentage of Overall Work Impairment	Week 24	The WPAI assess the impact of disease on work productivity and daily activities during the past seven days, using 6 questions regarding: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four main outcomes: 1 percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity.
Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-D)	Week 24	14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states.

Trial Locations

Locations (1)

National Center for Autoimmune Diseases, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark