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

Haemophilia Clinical Trial

— ADHAESIONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02197611
• Other study ID #: Haemo Adhaesione
• Secondary ID: Haemo-Adhaesione
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: October 19, 2015
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2015
• Source: Universidad de Murcia
• Contact: Ana Torres-Ortuño, PhD
• Phone: 868887170
• Email: atorres.ortuno[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

• 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with hemophilia A or B.

• Patients over 18 years of age.

Exclusion Criteria:

• Patients with neurological or cognitive impairments that hinder oral and written comprehension.

• Patients who have not signed the informed consent document

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No