Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.

NCT02197611 | Unknown

• 2 other identifiers: Haemo AdhaesioneHaemo-Adhaesione
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemophilia

Keywords

Haemophilia; Adherence of Treatment; Knowledge of Illness; Medical-patient Relationship; Illness Behavior; Treatment Difficulties.

Outcome Measures

Primary Outcomes (3)

• Phase substantive for the creation of a scale

  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

  Screening visit

• Structural phase for the creation of a scale

  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

  Screening visit

• Empirical phase for the creation of a scale

  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

  Screening visit

Study Arms (1)

Validation group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with haemophilia

You may qualify if:

• Patients diagnosed with hemophilia A or B.
• Patients over 18 years of age.

You may not qualify if:

• Patients with neurological or cognitive impairments that hinder oral and written comprehension.
• Patients who have not signed the informed consent document

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Universidad de Murcia

Murcia, Murcia, 30100, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Illness Behavior

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad Católica San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Torres-Ortuño, PhD

CONTACT

868887170; atorres.ortuno@gmail.com

RUBÉN CUESTA-BARRIUSO, PhD

CONTACT

968278806; ruben.cuestab@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 20, 2015

Record last verified: 2015-09

Locations

ES (1)