Relationship of Pain and Joint Status With the Perception of Psychosocial Factors in Patients With Hemophilic Arthropathy: A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assess the perception of joint pain with numerical scale of pain
研究概览
简要总结
Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Disability and functional limitations are characteristic sequelae of these patients from an early age.
Objective. To assess the joint status, the perception of quality of life, the performance of roles and the performance of daily life activities, in patients with hemophilic arthropathy.
Study design. Observational, multicenter study. Method. 70 patients with hemophilia A and B will be included in this study. Patients will be recruited from 4 centers in different regions of Spain. The dependent variables will be: pain (measured with the Visual Analogue Scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles, performance of daily life activities (Barthel scale), performing the instrumental activities of daily life (Lawton and Brody scale). The evolution of the variables will be analyzed using parametric (t-student or ANOVA) or non-parametric (Wilcoxon or Friedman) tests. A correlation analysis will be carried out between the dependent and independent variables, as well as a linear regression analysis between the observed determining variables.
Expected results. The aim is to observe the relationship of pain and joint status in patients with hemophilic arthropathy, with their perception of quality of life, the development of the roles they play and the performance of basic and instrumental activities of daily living.
详细描述
Main objective: To analyze the relationship of pain and joint status with psychosocial and functional variables in adult patients with hemophilic arthropathy.
Secondary objectives: i) To detect the relationship between joint damage in psychosocial disorders in patients with hemophilia; ii) Evaluate the performance and perception of roles with the clinical situation of patients with hemophilic arthropathy; iii) Identify the factors that influence the performance of basic and instrumental activities of daily living in adult patients with hemophilia; iv) Observe changes in the perception of quality of life, performance of roles and activities of daily life based on the clinical and sociodemographic characteristics of patients with hemophilia.
Patients who meet the selection criteria will be summoned to a meeting where the principal investigator will present, orally and in writing, the characteristics of the investigator, the intended objectives and the risks of the intervention. At said meeting, the following documentation will be provided: patient information document and informed consent document for patients.
After obtaining the informed consent of the patients, the evaluations will be carried out in the dependencies of the locations included in the study. Six dependent variables will be measured: pain, joint condition, perception of quality of life, list of roles, performance of basic activities of daily life, and performance of instrumental activities of daily life.
All joint state evaluations will be performed by the same physiotherapist, blinded to the objectives of the study. The evaluation of the questionnaires will be analyzed by another evaluator, blinded to the objectives of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemophilia A and B
- •Patients of legal age
- •Patients on prophylactic or on demand treatment with clotting factor concentrates.
排除标准
- •Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
- •Dependent patients who require help from a third person to get around
- •Patients who have developed a hemarthros in the 4 weeks prior to the study.
- •Patients who have not signed the informed consent document.
结局指标
主要结局
Assess the perception of joint pain with numerical scale of pain
时间窗: Screening visit
Measurement with numerical scale of pain. The patient must assign pain to a numerical value between two extreme points (0 to 10). Although the subject is asked to use numerical values to indicate the level of pain, the use of keywords, as well as previous instructions, are necessary if we expect the patient to conceptualize their pain in numerical terms. The scale is discrete, not continuous, but to perform statistical analyzes, equal intervals can be assumed between categories (score 0-10; higher scores mean a worse joint pain).
Assess the joint status with Hemophilia Joint Health Score
时间窗: Screening visit
Measurement the joint status with the instrument: Haemophilia Joint Health Score (score 0-120; higher scores mean a worse joint status).
次要结局
- Assess the carrying out activities of daily living(Screening visit)
- Assess the perception of quality of life with the questtionaire Short Form 36 Health Survey(Screening visit)
- Assess the list of roles with Oakley scale(Screening visit)
- Assess the instrumental activities of daily living(Screening visit)