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Status unknownNCT02197611ADHAESIONEUpdated Oct 20, 2015

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

An observational study in Haemophilia, sponsored by Universidad de Murcia. Status unknown at 1 site in Spain. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Universidad de Murcia · Observational

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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).
02

Conditions studied

  • Haemophilia

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Keywords

  • Haemophilia
  • Adherence of Treatment
  • Knowledge of Illness
  • Medical-patient Relationship
  • Illness Behavior
  • Treatment Difficulties.
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with haemophilia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with neurological or cognitive impairments that hinder oral and written comprehension.
  • Patients who have not signed the informed consent document
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Screening visit

  2. 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

    Time frame: Screening visit

  3. 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

    Time frame: Screening visit

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02197611
Lead sponsor
Universidad de Murcia
Responsible party
ANA TORRES-ORTUÑO (PhD, Universidad de Murcia) — Principal investigator
First posted
Jul 22, 2014
Start date
Sep 2015
Primary completion
Jan 2016 (estimated)
Completion
May 2016 (estimated)
Last update
Oct 20, 2015

Study contacts

Ana Torres-Ortuño, PhD
Contact
atorres.ortuno@gmail.com
868887170
RUBÉN CUESTA-BARRIUSO, PhD
Contact
ruben.cuestab@gmail.com
968278806
Rubén Cuesta-Barriuso, PhD
principal investigator · Universidad Católica San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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