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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non-Danish speaking
- •Expected to be unable to comply with the study protocol
结局指标
主要结局
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
时间窗: 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)
时间窗: 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.
次要结局
- Change in mean General Self-Efficacy scale scores(Week 24)
- 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 in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-A)(Week 24)
- Change from baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI:GH) Percentage of Overall Work Impairment(Week 24)
- Change in the mean Hospital Anxiety and Depression Scale - Anxiety (HADS-D)(Week 24)