<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/NCT02197611</url>
  </required_header>
  <id_info>
    <org_study_id>Haemo Adhaesione</org_study_id>
    <secondary_id>Haemo-Adhaesione</secondary_id>
    <nct_id>NCT02197611</nct_id>
  </id_info>
  <brief_title>Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.</brief_title>
  <acronym>ADHAESIONE</acronym>
  <official_title>Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. The Haemo-Adhaesione Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research project for the development, construction and validation of a questionnaire of&#xD;
      adherence to treatment in adult patients with hemophilia. It aims to build a scale according&#xD;
      to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2)&#xD;
      knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences&#xD;
      and difficulties, and 5) benefits of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Descriptive study for the construction of a multidimensional scale of adherence to&#xD;
           treatment in adult patients with hemophilia.&#xD;
&#xD;
        -  Validation of a scale specific measure for patients with hemophilia that includes 5&#xD;
           dimensions that may affect adherence to treatment: a) the doctor-patient, b) regarding&#xD;
           knowledge of the disease, c) the previous hemorrhages, d) knowledge future sequels, e)&#xD;
           difficulties with treatment.&#xD;
&#xD;
        -  Statistical and psychometric analysis of the adherence questionnaire for adult patients&#xD;
           with hemophilia.&#xD;
&#xD;
        -  Description of the theoretical framework that justifies the completion of the&#xD;
           questionnaire, and the choice of the dimensions and items that make up the measurement&#xD;
           scale.&#xD;
&#xD;
        -  The questionnaire obtained in this project will identify the actual degree of patient&#xD;
           adherence to multidisciplinary treatment, taking as gold standard, compliance with&#xD;
           pharmacological treatment (the difference between the treatment prescribed and&#xD;
           consumed).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2015</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</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>Phase substantive for the creation of a scale</measure>
    <time_frame>Screening visit</time_frame>
    <description>The theoretical framework and objectives for the creation of the scale is created. The questionnaire was developed teóricasdel dimensions and items of each dimension are identified. In this testing phase, the pilot is 5 Hematologists physicians experienced in hemophilia (no contact between them) and a sample of the target population (± 12 patients with hemophilia). The structure of this phase include:&#xD;
Identify and define the theorical framework of customs and attributes.&#xD;
Identification of behaviors that represent the attribute.&#xD;
Test design specifications.&#xD;
Construction of the items.&#xD;
External judgment by judges&#xD;
Discussion with the target population&#xD;
Analysis of item-objective congruence&#xD;
Analysis of the interview with patients and selection of items&#xD;
Selection of an initial set of items&#xD;
Application of the first version and analysis items&#xD;
Selection of items in accordance with standard psychometric</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Structural phase for the creation of a scale</measure>
    <time_frame>Screening visit</time_frame>
    <description>This phase is carried out the questionnaire to a pilot sample (± 50 patients with hemophilia) and the choice of format is made. Similarly, an analysis of differential functioning or bias of the items is performed. The structure of this phase include:&#xD;
Implementation of the final scale&#xD;
Determination of ground and ceiling effect of the scale&#xD;
Analysis of the structure of the scale&#xD;
Identifying relevant dimensions&#xD;
Calculate the reliability&#xD;
Determination of the reproducibility&#xD;
Establishing convergent and discriminant validity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Empirical phase for the creation of a scale</measure>
    <time_frame>Screening visit</time_frame>
    <description>This phase is carried out applying the scale to a general sample (patient 100-150). After the statistical and convergence and discriminant analysis (other scales) and the study of responsibility (with drug consumption data) will be made. The structure of this phase include:&#xD;
Selecting one or more external criteria&#xD;
To establish concurrent validity&#xD;
Checking empirical hypotheses&#xD;
Determination of responsiveness&#xD;
Study interpretability&#xD;
Design guidelines for the administration and scoring of scales&#xD;
Design cutoff scores</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Haemophilia</condition>
  <arm_group>
    <arm_group_label>Validation group</arm_group_label>
    <description>Group of patients who we will consult the characteristics of the scale designed and will be made the statistical calculations of validity, reliability and reproducibility</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with haemophilia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with hemophilia A or B.&#xD;
&#xD;
          -  Patients over 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neurological or cognitive impairments that hinder oral and written&#xD;
             comprehension.&#xD;
&#xD;
          -  Patients who have not signed the informed consent document&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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</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>Universidad de Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30100</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 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 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>Principal 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 of Treatment</keyword>
  <keyword>Knowledge of Illness</keyword>
  <keyword>Medical-patient Relationship</keyword>
  <keyword>Illness Behavior</keyword>
  <keyword>Treatment Difficulties.</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/NCT02197611
org study id: Haemo Adhaesione
secondary id: Haemo-Adhaesione
nct id: NCT02197611
lead sponsor: 
has dmc: No
Research project for the development, construction and validation of a questionnaire of
      adherence to treatment in adult patients with hemophilia. It aims to build a scale according
      to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2)
      knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences
      and difficulties, and 5) benefits of treatment.
-  Descriptive study for the construction of a multidimensional scale of adherence to
           treatment in adult patients with hemophilia.

        -  Validation of a scale specific measure for patients with hemophilia that includes 5
           dimensions that may affect adherence to treatment: a) the doctor-patient, b) regarding
           knowledge of the disease, c) the previous hemorrhages, d) knowledge future sequels, e)
           difficulties with treatment.

        -  Statistical and psychometric analysis of the adherence questionnaire for adult patients
           with hemophilia.

        -  Description of the theoretical framework that justifies the completion of the
           questionnaire, and the choice of the dimensions and items that make up the measurement
           scale.

        -  The questionnaire obtained in this project will identify the actual degree of patient
           adherence to multidisciplinary treatment, taking as gold standard, compliance with
           pharmacological treatment (the difference between the treatment prescribed and
           consumed).
observational model: Cohort
time perspective: Cross-Sectional
measure: Phase substantive for the creation of a scale
time frame: Screening visit
description: The theoretical framework and objectives for the creation of the scale is created. The questionnaire was developed teóricasdel dimensions and items of each dimension are identified. In this testing phase, the pilot is 5 Hematologists physicians experienced in hemophilia (no contact between them) and a sample of the target population (± 12 patients with hemophilia). The structure of this phase include:
Identify and define the theorical framework of customs and attributes.
Identification of behaviors that represent the attribute.
Test design specifications.
Construction of the items.
External judgment by judges
Discussion with the target population
Analysis of item-objective congruence
Analysis of the interview with patients and selection of items
Selection of an initial set of items
Application of the first version and analysis items
Selection of items in accordance with standard psychometric
measure: Structural phase for the creation of a scale
time frame: Screening visit
description: This phase is carried out the questionnaire to a pilot sample (± 50 patients with hemophilia) and the choice of format is made. Similarly, an analysis of differential functioning or bias of the items is performed. The structure of this phase include:
Implementation of the final scale
Determination of ground and ceiling effect of the scale
Analysis of the structure of the scale
Identifying relevant dimensions
Calculate the reliability
Determination of the reproducibility
Establishing convergent and discriminant validity
measure: Empirical phase for the creation of a scale
time frame: Screening visit
description: This phase is carried out applying the scale to a general sample (patient 100-150). After the statistical and convergence and discriminant analysis (other scales) and the study of responsibility (with drug consumption data) will be made. The structure of this phase include:
Selecting one or more external criteria
To establish concurrent validity
Checking empirical hypotheses
Determination of responsiveness
Study interpretability
Design guidelines for the administration and scoring of scales
Design cutoff scores
arm group label: Validation group
description: Group of patients who we will consult the characteristics of the scale designed and will be made the statistical calculations of validity, reliability and reproducibility
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rubén Cuesta-Barriuso, PhD
role: Principal Investigator
affiliation: Universidad Católica San Antonio
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: Principal Investigator
investigator affiliation: Universidad de Murcia
investigator full name: ANA TORRES-ORTUÑO
investigator title: PhD
mesh term: Hemophilia A