Clinical Trial: Adherence to Treatment in Hemophilia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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 Summary:

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.

Sponsor: ANA TORRES-ORTUÑO

Current Primary Outcome:

  • Assess the perception of quality of life [ Time Frame: Screening visit ]
    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.
  • Assess the perception of illness of the patients [ Time Frame: Screening visit ]
    To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).
  • Assess anxiety of patients and parents of children with hemophilia. [ Time Frame: Screening visit ]
    To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)
  • To assess illness behavior of patients. [ Time Frame: Screening visit ]
    To assess this variable we use the illness behaviour questionnaire (IBQ).
  • Assessing coping strategies of patients. [ Time Frame: Screening visit ]
    To assess this variable we use the Coping Scale questionnaire.
  • Assess the perception of family functioning of parents of children with hemophilia [ Time Frame: Screening visit ]
    To assess this variable we use the Family Functioning Evaluation Scale (FACES III).
  • Assess the perceived stress of parents of children with hemophilia. [ Time Frame: Screening visit ]
    To assess this variable we use the Pediatric Inventory for

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Assess the clinical data of the patient [ Time Frame: Screening visit ]
      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
    • Assess the demographic data of the patient [ Time Frame: Screening visit ]
      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


    Original Secondary Outcome: Same as current

    Information By: Universidad de Murcia

    Dates:
    Date Received: July 14, 2014
    Date Started: May 2015
    Date Completion: February 2016
    Last Updated: October 19, 2015
    Last Verified: September 2015