Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Evaluate impact through quality of life tool (PROMIS-29)
研究概览
简要总结
Characterizing the impact and treatment of reproductive tract bleeding on women and post-menarchal girls with bleeding disorders.
Objectives: This is a cross-sectional observational study of women and girls (WG) with bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset. Based on the investigators' study of currently available data of WG with bleeding disorders in the ATHNdataset, the investigators hypothesize that the information currently captured in the core data elements of the ATHNdatasest does not adequately capture data specific to WG with bleeding disorders. Further, the investigators hypothesize that it is feasible for Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated through the following specific aims:
Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding disorders cared for at US HTCs.
Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual bleeding in a cohort of females with bleeding disorders cared for at HTCs.
Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the ATHNdataset.
详细描述
This is a multi-center, cross-sectional study of women and girls with bleeding disorders receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this population, WG who receive care at federally funded US HTCs will be approached regarding participation. Following assent and/or consent, participants will be asked to complete a series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to assess their quality of life, they will complete the PROMIS-29 quality of life inventories. Patients may be contacted if they miss a question on any of these forms. Phone call should take no more than 15 minutes. Study staff will complete an intake form which includes data regarding bleeding disorder diagnosis as well as treatment, using information obtained from the patient, chart review, and the ATHNdataset.
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
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women and girls with an active diagnosis of a congenital bleeding disorder (as designated by the institution inputting data);
- •Deficiencies of factors VIII, IX, II, V, VII, VII, IX, X, XI, FV+VIII, XIII, Plasminogen Activator Inhibitor 1(PAI-1), hypo-, a-, or dys-fibrinogenemia
- •von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type 3, Low VWF)
- •Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome, Dense granule deficiency)
- •Ehlers Danlos Syndrome
- •Post-menarchal: has had at least 1 period at the time of study entry
- •Participating in the ATHNdataset
排除标准
- •Male gender
- •Acquired bleeding disorder
- •Thrombotic disorder
- •Non-English speaking
结局指标
主要结局
Evaluate impact through quality of life tool (PROMIS-29)
时间窗: 1 year
Participants will complete the PROMIS-29 quality of life tool.
Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)
时间窗: 1 year
The ISTH-BAT is the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool and can be self-administered. It provides an overall bleeding score as well as information about specific bleeding symptoms.
Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.
时间窗: 1 year
The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.
Reproductive tract bleeding will be characterized by reviewing the medical history
时间窗: 1 year
Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.
Evaluate impact through quality of life tool (EQ-5D)
时间窗: 1 year
Participants will complete the EQ-5D quality of life tool.
Identify treatment strategies for heavy menstrual bleeding through patient report
时间窗: 1 year
Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.
Evaluate the feasibility of entering female specific core data points to the ATHNdataset.
时间窗: 1 year
Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.
次要结局
未报告次要终点
研究者
Kristina Haley
Associate Professor
Oregon Health and Science University