ADHERENCE: Adherence to Treatment in Hemophilia

Sponsor

ANA TORRES-ORTUÑO (Other)

Overall Status

Unknown status

CT.gov ID

NCT02191436

Collaborator

Pfizer (Industry)

200

Enrollment

Location

9.1

Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Haemophilia

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Patients with haemophilia Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18

Outcome Measures

Primary Outcome Measures

Assess the perception of quality of life [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 [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. [Screening visit]
To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)
To assess illness behavior of patients. [Screening visit]
To assess this variable we use the illness behaviour questionnaire (IBQ).
Assessing coping strategies of patients. [Screening visit]
To assess this variable we use the Coping Scale questionnaire.
Assess the perception of family functioning of parents of children with hemophilia [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. [Screening visit]
To assess this variable we use the Pediatric Inventory for Parents (PIP).
Assessing the personality traits of children with hemophilia. [Screening visit]
To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)
Assess adherence to treatment of patients with hemophilia. [Screening visit]
To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).

Secondary Outcome Measures

Assess the clinical data of the patient [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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