HaemophiliaADHAESIONENCT02197611
Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.
An observational study of Haemophilia, run by Universidad de Murcia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Haemophilia
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to May 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with haemophilia
Who may be able to join
- Patients diagnosed with hemophilia A or B.
- Patients over 18 years of age.
Who cannot join
- Patients with neurological or cognitive impairments that hinder oral and written comprehension.
- Patients who have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Murcia
Murcia, Murcia, 30100
Ana Torres-Ortuño, PhD, 868887170, atorres.ortuno@gmail.com
Rubén Cuesta-Barriuso, PhD, 968278806, ruben.cuestab@gmail.com
About this study
Official title: 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.
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).
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties.
- Medical subject headings
- Hemophilia A, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening visit
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
Measured: Screening visit
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
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA TORRES-ORTUÑO, Universidad de Murcia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Católica San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197611
- Sponsor's protocol ID
- Haemo Adhaesione
- Other IDs
- Haemo-Adhaesione
- Acronym
- ADHAESIONE
- Status last verified
- Sep 2015
- First submitted
- 15 Jul 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. The Haemo-Adhaesione Questionnaire
- ClinicalTrials.gov ID
- NCT02197611
- Acronym / sponsor ID
- ADHAESIONE / Haemo Adhaesione
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with haemophilia
Key inclusion criteria (2 listed)
- Patients diagnosed with hemophilia A or B.
- Patients over 18 years of age.
Key exclusion criteria (2 listed)
- Patients with neurological or cognitive impairments that hinder oral and written comprehension.
- Patients who have not signed the informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Católica San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Torres-Ortuño, PhD (868887170, atorres.ortuno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase substantive for the creation of a scale (time frame: Screening visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.