Association of Prophylactic Treatment With Treatment Burden, Self-efficacy, Adherence, Sleep Quality, and Locus of Control in Patients With Hemophilia; an Ambispective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Assessment of treatment burden at the time of the study.
研究概览
简要总结
Introduction: Hemophilia is a congenital coagulopathy characterised by recurrent haemarthrosis, leading to chronic arthropathy and functional impairment. Prophylactic treatment with extended half-life (EHL) or short half-life (SHL) clotting factor concentrates is the most effective strategy for preventing these episodes. EHL products have demonstrated haemostatic efficacy, with a lower frequency of infusions, potentially reducing the treatment burden, although their psychosocial impact has not yet been sufficiently explored.
Objectives: To evaluate the association between perceived treatment burden and psychosocial variables such as self-efficacy, adherence, sleep quality and health locus of control, depending on the type of treatment received (EHL or SHL).
Methods. Multicentre, ambispective cohort study. A total of 114 patients with haemophilia A or B undergoing EHL or SHL prophylactic treatment will be included. The primary variable will be treatment burden (Treatment Burden Questionnaire). Secondary variables will be perceived self-efficacy (General Self-Efficacy Scale), adherence (Torres scale), sleep quality (Pittsburgh Sleep Quality Index), treatment adherence (Torres Questionnaire) and health locus of control (Multidimensional Health Locus of Control). Potential confounding variables will include sociodemographic data (age, educational level, living arrangements) and clinical data (number of weekly infusions, type of hospital).
Expected results: Patients treated with extended-half-life products are expected to report lower treatment burden, higher self-efficacy and better sleep quality, regardless of sociodemographic or clinical factors.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Patients with a medical diagnosis of hemophilia A or B.
- •Patients who, regardless of disease phenotype (mild, moderate or severe), are receiving prophylactic treatment with recombinant or plasma clotting factor concentrates, either short half-life or extended half-life.
- •Patients must have maintained the same treatment regimen (SHL or EHL) continuously for at least six months prior to participation.
排除标准
- •Patients who have developed inhibitors or antibodies to FVIII or FIX concentrates.
- •People with a concomitant diagnosis of other serious or disabling chronic diseases (neurological, oncological, severe psychiatric or rheumatological) that may interfere with the perceived burden of treatment, sleep quality, functionality or perception of self-efficacy.
- •Patients with cognitive, linguistic or sensory impairments that prevent them from correctly understanding and completing the questionnaires.
- •Patients who are participating in clinical trials or intensive monitoring programmes that may alter their perception of the treatment and generate biases in the evaluation.
结局指标
主要结局
Assessment of treatment burden at the time of the study.
时间窗: Screening visit.
Treatment burden will be assessed using the Spanish version of the Treatment Burden Questionnaire (TBQ). This self-administered multidimensional instrument consists of 15 items that measure the perceived burden of treatment in dimensions such as time spent, emotional impact, physical effort, medical coordination, and interference with daily life. Each item is scored on a Likert scale from 0 (no burden) to 10 (extreme burden). A total score is obtained, with higher values indicating greater perceived burden. This version has demonstrated good internal reliability in the Spanish chronic population (Cronbach's α = 0.89).
次要结局
- Assessment of adherence to treatment at the time of the study.(Screening visit.)
- Assessment of perceived self-efficacy in health at the time of the study.(Screening visit.)
- Assessment of health locus of control at the time of the study.(Screening visit.)
- Assessment of sleep quality at the time of the study.(Screening visit.)
- Assessment of the sociodemographic variable age at the time of the study.(Screening visit.)
- Assessment of the clinical variable number of weekly infusions of clotting factor concentrates at the time of the study.(Screening visit.)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia