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

October 19, 2015 updated by: ANA TORRES-ORTUÑO, Universidad de Murcia

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Screening visit
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 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
Time Frame: Screening visit

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haemo Adhaesione
  • Haemo-Adhaesione (Other Identifier: UMurcia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Haemophilia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe