Suicidal Ideation in Hereditary Angioedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS)
研究概览
简要总结
This study focuses on patients with Hereditary Angioedema (HAE) to better understand how mental health affects overall well-being. Through a questionnaire, the investigators will assess the presence of suicidal thoughts, anxiety, and depression, as well as cardiovascular risk markers. By analyzing these factors together, the investigators aim to identify possible links between mental health and heart health in people with HAE. This research will help improve care strategies and highlight the importance of mental well-being in managing HAE.
详细描述
This observational study focuses on patients with Hereditary Angioedema (HAE) to explore the impact of mental health on overall well-being. Through a questionnaire, the investigators aim to assess not only the presence but also the severity of suicidal thoughts, as well as symptoms of anxiety and depression. Additionally, the investigators will evaluate how these mental health factors relate to disease variables such as HAE control, disease activity, and quality of life.
Beyond mental health, the investigators also seek to understand its connection to cardiovascular risk factors. By measuring triglycerides, glucose levels, and body mass index (BMI), the investigators aim to explore whether patients with higher suicide risk also face increased heart health risks. This research will help improve patient care by emphasizing the importance of both mental and physical health in managing HAE. After identifying patients with high risk of suicide ideation the investigators will conduct a folow-up study after patients have received mental health interventions and how evaluate how treatment can determine better HAE outcomes. With these resuts the investigators expect to attract the attention of the international scientific community to increase early detection and effective solutions to prevent suicide.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Confirmed diagnosis of hereditary angioedema
- •Over the age of 18
排除标准
- •Patients with intellectual disability
- •Refusal to participate in the study
- •Patients with acquired C1-INH deficiency
- •Patients with other dermatological diseases.
结局指标
主要结局
Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS)
时间窗: Day 1
SIDAS measures five attributes of suicidal thoughts. Each attribute is scored on a 10-point scale, with total SIDAS scores ranging from 0 to 50. A score of 0= No ideation, 1-20= Low ideation, 21-50= High ideation .
次要结局
- Number of participant with an increased triglyceride glucose-body mass (TyG-BMI) index(In the previous 12 weeks or up to 12 weeks after enrollment)
- Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS(Day 1)
- Number of patients with uncontrolled disease as assessed by the Angioedema Control Test (AECT)(Day 1)
- Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS)(Day 1)
研究者
Ivan Cherrez Ojeda
Adjunct Professor
Charite University, Berlin, Germany
