Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
研究概览
简要总结
The purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors.
详细描述
This is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of Portuguese people with haemophilia (PWH). All PWH, registered in the Portuguese Hemophilia Association (APH) will be identified in APH registries and contacted through mail, in order to be invited to participate in the first Portuguese survey on haemophilia. In case of acceptance, patients must sign the Informed Consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system.
PWH of all ages are invited to participate in this survey. Adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. Parents of small children (0 to 9) will fill in the proxy versions. All questionnaires are adapted for the specific age groups.
This study will comply with ethic guidelines and was approved by the Life Sciences and Health Ethics Subcommittee (University of Minho) and is registered on the Portuguese authority for data collection (CNPD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemophilia A or B
- •Portuguese nationality
排除标准
- •Acquired Haemophilia
- •Psychiatric or neurological deficit
结局指标
主要结局
Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
时间窗: 1 year
Health Related Quality of Life in Children
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol
时间窗: 1 year
Pain Location
时间窗: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Intensity
时间窗: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Duration
时间窗: 1 year
Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
次要结局
- Presence of inibitors(1 year)
- Illness Perception as assessed by IPQ-R(1 year)
- Number of Joint Bleeds(1 year)
- Number of target joints(1 year)
- Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL(1 year)
- Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0(1 week)
- Type of sports practiced by PWH(1 year)
- Depression score as assessed by PROMIS-Depression Short Form v1.0(1 week)
- Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale(1 year)
研究者
Patrícia Ribeiro Pinto
Post-doctoral fellow
University of Minho