NCT04200690

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

December 10, 2019

Last Update Submit

May 31, 2023

Conditions

PsoriasisPsoriatic ArthritisAxial SpondyloarthritisHidradenitis SuppurativaCrohn DiseaseUlcerative Colitis

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)

    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.

    24 Weeks

  • Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)

    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.

    24 Weeks

Secondary Outcomes (6)

  • Proportion of subjects achieving Minimal Clinical Important Difference (MCID) on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)

    24 Weeks

  • Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

    Week 24

  • Change from baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI:GH) Percentage of Overall Work Impairment

    Week 24

  • Change in mean General Self-Efficacy scale scores

    Week 24

  • Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

    Week 24

  • +1 more secondary outcomes

Other Outcomes (20)

  • Change From Baseline in Dermatology Life Quality Index (DLQI)

    24 and 48 Weeks

  • Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI)

    24 and 48 Weeks

  • Change in the mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    24 and 48 Weeks

  • +17 more other outcomes

Study Arms (2)

Interdisciplinary management

EXPERIMENTAL

Interdisciplinary combined clinical care

Other: Interdisciplinary management

Usual-care management

ACTIVE COMPARATOR

Usual-care

Other: Usual-care management

Interventions

Interdisciplinary managementOTHER

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.

Interdisciplinary management
Usual-care managementOTHER

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.

Usual-care management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained from the subject prior to randomization.
  • Age 18 and above.
  • 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.

You may not qualify if:

  • Non-Danish speaking
  • Expected to be unable to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Autoimmune Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33910945DERIVED

MeSH Terms

Conditions

PsoriasisArthritis, PsoriaticAxial SpondyloarthritisHidradenitis SuppurativaCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAnkylosisSkin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationHidradenitisSweat Gland DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Kasper F Hjuler, MD PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Lars Iversen, MD PhD DMSc

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 16, 2019

Study Start

January 14, 2020

Primary Completion

January 31, 2023

Study Completion

January 31, 2024

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

DK(1)