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

NCT ID: NCT02197611

Last Updated: 2015-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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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 Description

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* 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).

Conditions

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Haemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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ANA TORRES-ORTUÑO

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio

Locations

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Universidad de Murcia

Murcia, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ana Torres-Ortuño, PhD

Role: CONTACT

868887170

RUBÉN CUESTA-BARRIUSO, PhD

Role: CONTACT

968278806

Facility Contacts

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Ana Torres-Ortuño, PhD

Role: primary

868887170

Rubén Cuesta-Barriuso, PhD

Role: backup

968278806

Other Identifiers

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Haemo-Adhaesione

Identifier Type: OTHER

Identifier Source: secondary_id

Haemo Adhaesione

Identifier Type: -

Identifier Source: org_study_id

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