<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02191436</url>
  </required_header>
  <id_info>
    <org_study_id>ADHERENCE</org_study_id>
    <secondary_id>ADHE</secondary_id>
    <nct_id>NCT02191436</nct_id>
  </id_info>
  <brief_title>Adherence to Treatment in Hemophilia</brief_title>
  <acronym>ADHERENCE</acronym>
  <official_title>Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANA TORRES-ORTUÑO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter&#xD;
      study. Multicenter cross sectional study of patients with hemophilia and their families&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research project whose main objective is to assess adherence and major psychosocial issues&#xD;
      affecting patients with hemophilia and their families treated at the Hematology and&#xD;
      hemotherapy Services Clinical Hospital Universitario Virgen de la Arrixaca of Murcia and the&#xD;
      University Hospital Carlos Haya, Malaga.&#xD;
&#xD;
      The data obtained in this project will identify those psychosocial aspects affecting patients&#xD;
      and their families about the disease, its evolution and treatment of it. They will use&#xD;
      different psychosocial questionnaires based on scientific evidence and the reliability of&#xD;
      these, as well as its specific design for hemophilia patients. The main characteristics of&#xD;
      the study are:&#xD;
&#xD;
        -  Descriptive study of adherence to treatment of pediatric patients, adolescents and&#xD;
           adults with hemophilia.&#xD;
&#xD;
        -  Descriptive study of family functioning, perceived stress, anxiety and quality of life&#xD;
           in parents of children with hemophilia under 14 years and adolescents with hemophilia,&#xD;
           depending on the administered medical treatment, clinical and musculoskeletal patient&#xD;
           situation.&#xD;
&#xD;
        -  Descriptive study of illness behavior or perception of illness, perceived stress,&#xD;
           anxiety, quality of life and coping strategies of young adults with hemophilia,&#xD;
           depending on the medical treatment administered, and skeletal muscle clinical situation&#xD;
           of the patient.&#xD;
&#xD;
        -  Validation of psychosocial assessment tools in patients with hemophilia and their&#xD;
           families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Assess the perception of quality of life</measure>
    <time_frame>Screening visit</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the perception of illness of the patients</measure>
    <time_frame>Screening visit</time_frame>
    <description>To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess anxiety of patients and parents of children with hemophilia.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess illness behavior of patients.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the illness behaviour questionnaire (IBQ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing coping strategies of patients.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the Coping Scale questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the perception of family functioning of parents of children with hemophilia</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the Family Functioning Evaluation Scale (FACES III).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the perceived stress of parents of children with hemophilia.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the Pediatric Inventory for Parents (PIP).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing the personality traits of children with hemophilia.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess adherence to treatment of patients with hemophilia.</measure>
    <time_frame>Screening visit</time_frame>
    <description>To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the clinical data of the patient</measure>
    <time_frame>Screening visit</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the demographic data of the patient</measure>
    <time_frame>Screening visit</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Haemophilia</condition>
  <arm_group>
    <arm_group_label>Patients with haemophilia</arm_group_label>
    <description>Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with haemophilia treated at the Hospital Clínico Universitario Virgen de la&#xD;
        Arrixaca de Murcia, and the Hospital Clínico Universitario Carlos Haya (Málaga)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with hemophilia A or B&#xD;
&#xD;
          -  Patients followed at the Hematology Department of the hospitals included in the study&#xD;
&#xD;
          -  Patients without cognitive disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other congenital coaguopatías&#xD;
&#xD;
          -  Patients with more than 2 years without going to review your hospital&#xD;
&#xD;
          -  Patients from other provinces of Spain&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ANA TORRES-ORTUÑO, PhD</last_name>
    <phone>868887170</phone>
    <email>atorres.ortuno@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
    <phone>968278806</phone>
    <email>ruben.cuestab@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ANA TORRES-ORTUÑO, PhD</last_name>
      <phone>868887170</phone>
      <email>atorres.ortuno@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>RUBÉN CUESTA-BARRIUSO, PhD</last_name>
      <phone>968278806</phone>
      <email>ruben.cuestab@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Murcia</investigator_affiliation>
    <investigator_full_name>ANA TORRES-ORTUÑO</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Haemophilia</keyword>
  <keyword>Adherence</keyword>
  <keyword>Family Functioning</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Illness Behavior</keyword>
  <keyword>Coping Strategies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191436
org study id: ADHERENCE
secondary id: ADHE
nct id: NCT02191436
lead sponsor: 
collaborator: 
has dmc: No
Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter
      study. Multicenter cross sectional study of patients with hemophilia and their families
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assess the perception of quality of life
time frame: Screening visit
description: 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.
measure: Assess the perception of illness of the patients
time frame: Screening visit
description: To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).
measure: Assess anxiety of patients and parents of children with hemophilia.
time frame: Screening visit
description: To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)
measure: To assess illness behavior of patients.
time frame: Screening visit
description: To assess this variable we use the illness behaviour questionnaire (IBQ).
measure: Assessing coping strategies of patients.
time frame: Screening visit
description: To assess this variable we use the Coping Scale questionnaire.
measure: Assess the perception of family functioning of parents of children with hemophilia
time frame: Screening visit
description: To assess this variable we use the Family Functioning Evaluation Scale (FACES III).
measure: Assess the perceived stress of parents of children with hemophilia.
time frame: Screening visit
description: To assess this variable we use the Pediatric Inventory for Parents (PIP).
measure: Assessing the personality traits of children with hemophilia.
time frame: Screening visit
description: To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)
measure: Assess adherence to treatment of patients with hemophilia.
time frame: Screening visit
description: To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).
measure: Assess the clinical data of the patient
time frame: Screening visit
description: 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
measure: Assess the demographic data of the patient
time frame: Screening visit
description: 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
arm group label: Patients with haemophilia
description: Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 6 Years
maximum age: 75 Years
healthy volunteers: No
last name: RUBÉN CUESTA-BARRIUSO, PhD
role: Principal Investigator
affiliation: UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
last name: ANA TORRES-ORTUÑO, PhD
phone: 868887170
email: atorres.ortuno@gmail.com
last name: RUBÉN CUESTA-BARRIUSO, PhD
phone: 968278806
email: ruben.cuestab@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad de Murcia
investigator full name: ANA TORRES-ORTUÑO
investigator title: PhD
mesh term: Hemophilia A