Adherence to Treatment in Hemophilia

Haemophilia Clinical Trial

— ADHERENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02191436
• Other study ID #: ADHERENCE
• Secondary ID: ADHE
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2014
• Last updated: October 19, 2015
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Universidad de Murcia
• Contact: ANA TORRES-ORTUÑO, PhD
• Phone: 868887170
• Email: atorres.ortuno[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
ANA TORRES-ORTUÑO	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Assess the perception of illness of the patients	To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).	Screening visit	No
Primary	Assess anxiety of patients and parents of children with hemophilia.	To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)	Screening visit	No
Primary	To assess illness behavior of patients.	To assess this variable we use the illness behaviour questionnaire (IBQ).	Screening visit	No
Primary	Assessing coping strategies of patients.	To assess this variable we use the Coping Scale questionnaire.	Screening visit	No
Primary	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	No
Primary	Assess the perceived stress of parents of children with hemophilia.	To assess this variable we use the Pediatric Inventory for Parents (PIP).	Screening visit	No
Primary	Assessing the personality traits of children with hemophilia.	To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)	Screening visit	No
Primary	Assess adherence to treatment of patients with hemophilia.	To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).	Screening visit	No
Secondary	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	No
Secondary	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	No