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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. The Haemo-Adhaesione Questionnaire

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.

Detailed Summary:

  • 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).

Sponsor: Universidad de Murcia

Current Primary Outcome:

  • Phase substantive for the creation of a scale [ Time Frame: Screening visit ]

    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
  • Structural phase for the creation of a scale [ Time Frame: Screening visit ]

    This phase is carried out the questionnaire to a pilot sample (± 50 patients with hemophilia) and the choice of format is made. Similarly, an analys

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Universidad de Murcia

    Dates:
    Date Received: July 15, 2014
    Date Started: September 2015
    Date Completion: May 2016
    Last Updated: October 19, 2015
    Last Verified: September 2015