Adherence to Treatment in Hemophilia

Study Overview
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Brief Summary
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Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families

Detailed Description
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Research project whose main objective is to assess adherence and major psychosocial issues affecting patients with hemophilia and their families treated at the Hematology and hemotherapy Services Clinical Hospital Universitario Virgen de la Arrixaca of Murcia and the University Hospital Carlos Haya, Malaga. The data obtained in this project will identify those psychosocial aspects affecting patients and their families about the disease, its evolution and treatment of it. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for hemophilia patients. The main characteristics of the study are: Descriptive study of adherence to treatment of pediatric patients, adolescents and adults with hemophilia. Descriptive study of family functioning, perceived stress, anxiety and quality of life in parents of children with hemophilia under 14 years and adolescents with hemophilia, depending on the administered medical treatment, clinical and musculoskeletal patient situation. Descriptive study of illness behavior or perception of illness, perceived stress, anxiety, quality of life and coping strategies of young adults with hemophilia, depending on the medical treatment administered, and skeletal muscle clinical situation of the patient. Validation of psychosocial assessment tools in patients with hemophilia and their families.

Official Title
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Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study

Conditions
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Haemophilia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hemophilia A or B Patients followed at the Hematology Department of the hospitals included in the study Patients without cognitive disorders Exclusion Criteria: Patients with other congenital coaguopatías Patients with more than 2 years without going to review your hospital Patients from other provinces of Spain

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia<br>Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the perception of quality of life | The quality of life assessed with the questionnaires: Short Form-36 Health Survey (SF-36) and A36 Hemofilia-QoL for adults; and Child Report Form (CHIP-CE) and Haemo-QoL, for children. | Screening visit | 
| Assess the perception of illness of the patients | To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R). | Screening visit | 
| Assess anxiety of patients and parents of children with hemophilia. | To evaluate this variable we use the State-Trait Anxiety Inventory (STAI) | Screening visit | 
| To assess illness behavior of patients. | To assess this variable we use the illness behaviour questionnaire (IBQ). | Screening visit | 
| Assessing coping strategies of patients. | To assess this variable we use the Coping Scale questionnaire. | Screening visit | 
| Assess the perception of family functioning of parents of children with hemophilia | To assess this variable we use the Family Functioning Evaluation Scale (FACES III). | Screening visit | 
| Assess the perceived stress of parents of children with hemophilia. | To assess this variable we use the Pediatric Inventory for Parents (PIP). | Screening visit | 
| Assessing the personality traits of children with hemophilia. | To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J) | Screening visit | 
| Assess adherence to treatment of patients with hemophilia. | To assess this variable we use the Beliefs About Medication Questionnaire (BMQ). | Screening visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the clinical data of the patient | Type of hemophilia (A or B), severity of hemophilia (severe, moderate or mild), treatment type (a demand or prophylaxis), presence of ingibidores, history of hemarthrosis, dosage factor VIII / IX | Screening visit | 
| Assess the demographic data of the patient | Age, history of hemophilia in the family, marital status (single, married, divorced), education (university, basic), employment status (unemployed, self-employed, employed by others), distance to hospital | Screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia, Adherence, Family Functioning, Quality of Life, Anxiety, Illness Behavior, Coping Strategies