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Adherence to Treatment in Hemophilia (ADHERENCE)

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ClinicalTrials.gov Identifier: NCT02191436
Recruitment Status : Unknown
Verified September 2015 by ANA TORRES-ORTUÑO, Universidad de Murcia.
Recruitment status was:  Recruiting
First Posted : July 16, 2014
Last Update Posted : October 20, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ANA TORRES-ORTUÑO, Universidad de Murcia

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study
Study Start Date : May 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with haemophilia
Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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)

  4. To assess illness behavior of patients. [ Time Frame: Screening visit ]
    To assess this variable we use the illness behaviour questionnaire (IBQ).

  5. Assessing coping strategies of patients. [ Time Frame: Screening visit ]
    To assess this variable we use the Coping Scale questionnaire.

  6. 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).

  7. Assess the perceived stress of parents of children with hemophilia. [ Time Frame: Screening visit ]
    To assess this variable we use the Pediatric Inventory for Parents (PIP).

  8. Assessing the personality traits of children with hemophilia. [ Time Frame: Screening visit ]
    To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)

  9. Assess adherence to treatment of patients with hemophilia. [ Time Frame: Screening visit ]
    To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191436


Contacts
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Contact: ANA TORRES-ORTUÑO, PhD 868887170 atorres.ortuno@gmail.com
Contact: RUBÉN CUESTA-BARRIUSO, PhD 968278806 ruben.cuestab@gmail.com

Locations
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Spain
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Contact: ANA TORRES-ORTUÑO, PhD    868887170    atorres.ortuno@gmail.com   
Contact: RUBÉN CUESTA-BARRIUSO, PhD    968278806    ruben.cuestab@gmail.com   
Sponsors and Collaborators
ANA TORRES-ORTUÑO
Pfizer
Investigators
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Principal Investigator: RUBÉN CUESTA-BARRIUSO, PhD UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
More Information
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Additional Information:

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Responsible Party: ANA TORRES-ORTUÑO, PhD, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT02191436    
Other Study ID Numbers: ADHERENCE
ADHE ( Other Identifier: UMU )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: September 2015
Keywords provided by ANA TORRES-ORTUÑO, Universidad de Murcia:
Haemophilia
Adherence
Family Functioning
Quality of Life
 Anxiety
Illness Behavior
Coping Strategies
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn