Development of a Risk Assessment Tool for Incontinence-associated Dermatitis (IAD): a Cohort Study on the Predictive Performance of Risk Factors for IAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 7
- 主要终点
- Association between prognostic factors and the development of IAD
研究概览
简要总结
Objective: The primary goal of this prospective cohort study is to collect data on specific factors, including age, sex, stool consistency, etc. and assess their association with the development of IAD. Through the compilation of this data, the study aims to determine whether the identified factors are indeed risk factors for the occurrence of IAD.
Study design: Prospective observational cohort study
Methodology:
This is a multi-center, prospective cohort study in hospitals in Sweden and Belgium. Adult patients (≥18 years) who are incontinent and free of IAD at baseline will be enrolled following informed consent.
Data collection: Daily skin assessments of the perineal area will be conducted by trained nurses using the validated Ghent Global Incontinence-Associated Dermatitis Tool (GLOBIAD). If IAD is detected, standardized photographs will be taken for blinded central review by skin integrity experts. Clinical, demographic, and care-related data will be collected, including variables such as age, sex, stool consistency, mobility, hygiene practices, nutrition, medication use, and comorbidities.
The primary endpoint for this study is to establish an association between the identified factors and the development of IAD in the study population.
详细描述
Problem Statement:
Incontinence-Associated Dermatitis (IAD) is a type of irritant contact dermatitis caused by prolonged skin exposure to urine and/or feces. It commonly affects individuals with incontinence. IAD is associated with decreased quality of life, increased care burden, loss of independence, and higher susceptibility to secondary infections and pressure ulcers. These complications lead to prolonged hospital stays and increased healthcare costs.
Despite its clinical relevance, there is insufficient consensus regarding the most critical risk factors for IAD. Existing literature points to a wide range of potential contributors including patient demographics, comorbidities, hygiene practices, and care protocols. A comprehensive prospective study is needed to investigate these risk factors within a hospitalized population in order to inform effective prevention and management strategies.
Methodology:
A prospective cohort design will be conducted across multiple hospital settings in Sweden and Belgium. The study targets adult patients, aged 18 years or older, who suffer from urinary, fecal, or double incontinence upon admission to the hospital and are free of IAD at enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient or their legally authorized representative signed informed consent.
- •The patient is aged 18 years or older.
- •The patient suffers from incontinence* (urinary, faecal, double incontinence).
- •The patient is free of IAD at inclusion. *Incontinence is defined as involuntary loss of urine and/or stool.
排除标准
- •Patients admitted to emergency departments, paediatric units, maternity units, psychiatric units, and palliative care units.
- •Patients who are receiving end-of-life care.
结局指标
主要结局
Association between prognostic factors and the development of IAD
时间窗: 12 months
This outcome will assess the relationship between selected prognostic factors (e.g., age, sex, stool consistency, type of incontinence) and the development of incontinence-associated dermatitis (IAD) in hospitalized incontinent patients. IAD status will be assessed using the GLOBIAD (Ghent Global IAD Categorisation Tool). The association between each prognostic factor and IAD will be evaluated using multivariable logistic regression analysis.
次要结局
- Incidence of Incontinence-Associated Dermatitis (IAD) in hospitalized incontinent patients(12 months (during the hospital stay of each enrolled patient, over the 12-month study period))