HaemophiliaADHERENCENCT02191436
Adherence to Treatment in Hemophilia
An observational study of Haemophilia, run by ANA TORRES-ORTUÑO at 1 site in Spain.
Trial summary
Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families Read more about this study
- Who is it for?
- Ages 6 to 75 years, men only
- Conditions the study is for
- Haemophilia
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Feb 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 6 to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia treated at the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia, and the Hospital Clínico Universitario Carlos Haya (Málaga)
Who may be able to join
- Patients with hemophilia A or B
- Patients followed at the Hematology Department of the hospitals included in the study
- Patients without cognitive disorders
Who cannot join
- Patients with other congenital coaguopatías
- Patients with more than 2 years without going to review your hospital
- Patients from other provinces of Spain
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
ANA TORRES-ORTUÑO, PhD, 868887170, atorres.ortuno@gmail.com
RUBÉN CUESTA-BARRIUSO, PhD, 968278806, ruben.cuestab@gmail.com
About this study
Official title: Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study
Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families
Read the detailed description
Research project whose main objective is to assess adherence and major psychosocial issues affecting patients with hemophilia and their families treated at the Hematology and hemotherapy Services Clinical Hospital Universitario Virgen de la Arrixaca of Murcia and the University Hospital Carlos Haya, Malaga.
The data obtained in this project will identify those psychosocial aspects affecting patients and their families about the disease, its evolution and treatment of it. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for hemophilia patients. The main characteristics of the study are:
- Descriptive study of adherence to treatment of pediatric patients, adolescents and adults with hemophilia.
- Descriptive study of family functioning, perceived stress, anxiety and quality of life in parents of children with hemophilia under 14 years and adolescents with hemophilia, depending on the administered medical treatment, clinical and musculoskeletal patient situation.
- Descriptive study of illness behavior or perception of illness, perceived stress, anxiety, quality of life and coping strategies of young adults with hemophilia, depending on the medical treatment administered, and skeletal muscle clinical situation of the patient.
- Validation of psychosocial assessment tools in patients with hemophilia and their families.
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence, Family Functioning, Quality of Life, Anxiety, Illness Behavior, Coping Strategies
- Medical subject headings
- Hemophilia A, Anxiety Disorders, 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 |
|---|---|---|
| Patients with haemophilia | Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the perception of quality of life
The quality of life assessed with the questionnaires: Short Form-36 Health Survey (SF-36) and A36 Hemofilia-QoL for adults; and Child Report Form (CHIP-CE) and Haemo-QoL, for children.
Measured: Screening visit
Assess the perception of illness of the patients
To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).
Measured: Screening visit
Assess anxiety of patients and parents of children with hemophilia.
To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)
Measured: Screening visit
To assess illness behavior of patients.
To assess this variable we use the illness behaviour questionnaire (IBQ).
Measured: Screening visit
Assessing coping strategies of patients.
To assess this variable we use the Coping Scale questionnaire.
Measured: Screening visit
Assess the perception of family functioning of parents of children with hemophilia
To assess this variable we use the Family Functioning Evaluation Scale (FACES III).
Measured: Screening visit
Assess the perceived stress of parents of children with hemophilia.
To assess this variable we use the Pediatric Inventory for Parents (PIP).
Measured: Screening visit
Assessing the personality traits of children with hemophilia.
To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)
Measured: Screening visit
Assess adherence to treatment of patients with hemophilia.
To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).
Measured: Screening visit
Secondary outcomes (2)
Assess the clinical data of the patient
Type of hemophilia (A or B), severity of hemophilia (severe, moderate or mild), treatment type (a demand or prophylaxis), presence of ingibidores, history of hemarthrosis, dosage factor VIII / IX
Measured: Screening visit
Assess the demographic data of the patient
Age, history of hemophilia in the family, marital status (single, married, divorced), education (university, basic), employment status (unemployed, self-employed, employed by others), distance to hospital
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 posted16 Jul 2014 (estimated)
- Study startMay 2015
- Primary completionNov 2015 (estimated)
- Study completionFeb 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
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- ANA TORRES-ORTUÑO
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, ANA TORRES-ORTUÑO, Universidad de Murcia
- Investigators
- RUBÉN CUESTA-BARRIUSO, PhD, Principal investigator, UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191436
- Sponsor's protocol ID
- ADHERENCE
- Other IDs
- ADHE
- Acronym
- ADHERENCE
- Status last verified
- Sep 2015
- First submitted
- 14 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
- Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study
- ClinicalTrials.gov ID
- NCT02191436
- Acronym / sponsor ID
- ADHERENCE / ADHERENCE
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence, Family Functioning, Quality of Life, Anxiety, Illness Behavior, Coping Strategies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ANA TORRES-ORTUÑOUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 16 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.
Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families
Detailed description
Research project whose main objective is to assess adherence and major psychosocial issues affecting patients with hemophilia and their families treated at the Hematology and hemotherapy Services Clinical Hospital Universitario Virgen de la Arrixaca of Murcia and the University Hospital Carlos Haya, Malaga.
The data obtained in this project will identify those psychosocial aspects affecting patients and their families about the disease, its evolution and treatment of it. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for hemophilia patients. The main characteristics of the study are:
- Descriptive study of adherence to treatment of pediatric patients, adolescents and adults with hemophilia.
- Descriptive study of family functioning, perceived stress, anxiety and quality of life in parents of children with hemophilia under 14 years and adolescents with hemophilia, depending on the administered medical treatment, clinical and musculoskeletal patient situation.
- Descriptive study of illness behavior or perception of illness, perceived stress, anxiety, quality of life and coping strategies of young adults with hemophilia, depending on the medical treatment administered, and skeletal muscle clinical situation of the patient.
- Validation of psychosocial assessment tools in patients with hemophilia and their families.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia | – | –Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18 |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia treated at the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia, and the Hospital Clínico Universitario Carlos Haya (Málaga)
Key inclusion criteria (3 listed)
- Patients with hemophilia A or B
- Patients followed at the Hematology Department of the hospitals included in the study
- Patients without cognitive disorders
Key exclusion criteria (3 listed)
- Patients with other congenital coaguopatías
- Patients with more than 2 years without going to review your hospital
- Patients from other provinces of Spain
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
Assess the perception of quality of life
Time frame: Screening visit
The quality of life assessed with the questionnaires: Short Form-36 Health Survey (SF-36) and A36 Hemofilia-QoL for adults; and Child Report Form (CHIP-CE) and Haemo-QoL, for children.
Assess the perception of illness of the patients
Time frame: Screening visit
To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).
Assess anxiety of patients and parents of children with hemophilia.
Time frame: Screening visit
To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)
To assess illness behavior of patients.
Time frame: Screening visit
To assess this variable we use the illness behaviour questionnaire (IBQ).
Assessing coping strategies of patients.
Time frame: Screening visit
To assess this variable we use the Coping Scale questionnaire.
Assess the perception of family functioning of parents of children with hemophilia
Time frame: Screening visit
To assess this variable we use the Family Functioning Evaluation Scale (FACES III).
Assess the perceived stress of parents of children with hemophilia.
Time frame: Screening visit
To assess this variable we use the Pediatric Inventory for Parents (PIP).
Assessing the personality traits of children with hemophilia.
Time frame: Screening visit
To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)
Assess adherence to treatment of patients with hemophilia.
Time frame: Screening visit
To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).
2 secondary outcomes
Assess the clinical data of the patient
Time frame: Screening visit
Assess the demographic data of the patient
Time frame: Screening visit
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, MURCIA
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 ANA TORRES-ORTUÑO 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 3 inclusion and 3 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?
Assess the perception of quality of life (time frame: Screening visit). The study lists 9 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; AzTrials last refreshed its copy on 6 Nov 2026.