Factors Affecting Health Promoting Behavior in Rare Disease Patients: A Mixed Methods Study of Men With Congenital Hypogonadotropic Hypogonadism (CHH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- understandability and actionability of patient education materials
研究概览
简要总结
Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a rare endocrine disorder that is characterized by failure to undergo puberty combined with infertility. KS/CHH patients face a number of psychosocial burdens related to delays in diagnosis, inadequate access to expert care, and lack of information about the condition. As such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This study aims to identify the needs of patients and understand the issues that must be overcome to achieve improved health and quality of life.
详细描述
This study aims to examine the experiences of patients diagnosed with Kallmann syndrome (KS)/congenital hypogonadotropic hypogonadism (CHH).
The study includes two parts:
- online survey (less than 30 minutes to complete)
- focus groups with KS/CHH patients
The aim of this project is to better understand what health needs are not presently being met for these patients and to identify targets for improving the care of patients diagnosed with KS/CHH
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with congenital hypogonadotropic hypogonadism: i.e. Kallmann syndrome or idiopathic hypogonadotropic hypogonadism
- •Primary language is English/capable of responding to a written questionnaire in English
- •Consenting to participate in the study
排除标准
- •other diagnosis of hypogonadism: i.e. hypergonadotropic hypogonadism (Klinefelter syndrome), adult onset hypogonadism, etc.
结局指标
主要结局
understandability and actionability of patient education materials
时间窗: baeline
completion of Patient Education Materials Assessment Tool (PEMAT)
illness perception
时间窗: baseline
subjective self-assessment questionnaire of how KS/CHH impacts a patient's life
adherence to treatment
时间窗: baseline
self-report of adherence to medication treatment and periods without treatment or healthcare
depression symptoms
时间窗: baseline
self-rated questionnaire of depression symptoms
次要结局
- coping(baseline)
- Interactions wth healthcare(baseline)
研究者
Andrew Dwyer
Assistant Professor
Centre Hospitalier Universitaire Vaudois