Clinical trial NCT02191436: Adherence to Treatment in Hemophilia
Official title: Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Keywords: Haemophilia
Adherence
Family Functioning
Quality of Life
Anxiety
Illness Behavior
Coping Strategies
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-07-16
Enrollment: 200
Sex: MALE
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia treated at the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia, and the Hospital Clínico Universitario Carlos Haya (Málaga)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the perception of quality of life
timeFrame: Screening visit
measure: Assess the perception of illness of the patients
timeFrame: Screening visit
measure: Assess anxiety of patients and parents of children with hemophilia.
timeFrame: Screening visit
measure: To assess illness behavior of patients.
timeFrame: Screening visit
measure: Assessing coping strategies of patients.
timeFrame: Screening visit
measure: Assess the perception of family functioning of parents of children with hemophilia
timeFrame: Screening visit
measure: Assess the perceived stress of parents of children with hemophilia.
timeFrame: Screening visit
measure: Assessing the personality traits of children with hemophilia.
timeFrame: Screening visit
measure: Assess adherence to treatment of patients with hemophilia.
timeFrame: Screening visit
Secondary outcomes:
measure: Assess the clinical data of the patient
timeFrame: Screening visit
measure: Assess the demographic data of the patient
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
name: RUBÉN CUESTA-BARRIUSO, PhD
role: PRINCIPAL_INVESTIGATOR
References: