Patients With HaemophiliaibHEroNCT02199639
Transcultural Multidisciplinary Evaluation of Patients With Hemophili
An observational study of Patients With Haemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain, El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the degree of injury, age, presence of… Read more about this study
- Who is it for?
- Ages 6 to 65 years, men only
- Conditions the study is for
- Patients With Haemophilia
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Dec 2015
- 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 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia from Spain, El Salvador and Bolivia
Who may be able to join
- Patients with hemophilia A and B.
- Patients of all ages (pediatric, adolescents, youth and adults).
- With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
- Patients with or without inhibitors.
Who cannot join
- Patients without prior ambulation capacity.
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Católica San Antonio de Murcia
Murcia, Murcia, 30107
RUBÉN CUESTA-BARRIUSO, PhD, 968278806, ruben.cuestab@gmail.com
ANA TORRES-ORTUÑO, PhD, 968278806, atorres.ortuno@gmail.com
About this study
Official title: Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain, El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the degree of injury, age, presence of inhibitors and the development of physical activity; identify the relationship between the functional deficit by clinical assessment performed with the use of validated measurement scales, the assessment of the degree of injury to specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their impact on gait in patients with hemophilia; and evaluate the factors that influence the perception of illness and quality of life of patients with hemophilia.
Read the detailed description
Descriptive study of joint involvement in patients with hemophilia Spain, El Salvador and Bolivia.
Descriptive study of abnormal joint mobility and muscle strength as a result of acute conditions or the development of chronic articular sequelae.
Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.
Descriptive study of the overall articular involvement (crepitus, pain, biomechanical and functional changes) in patients with hemophilia.
Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perception of it, and their quality of life.
- Conditions
- Patients With Haemophilia
- Keywords
- Haemophilia, Arthropathy, Range of Movement, Strength, Proprioception, Gait, Quality of Life
- Medical subject headings
- Hemophilia A, Joint Diseases
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 |
|---|---|---|
| Spain | Group of patients with hemophilia recruited in the Region of Murcia (Spain) and evaluated in the Universidad Católica San Antonio between June and July 2014. | |
| El Salvador | Group of patients with hemophilia recruited in the city of San Salvador (El Salvador) and evaluated in the Hospital Nacional Rosales and the Hospital Nacional de niños "Benjamín Bloom" from San Salvador in April 2014. | |
| Bolivia | Group of patients with hemophilia recruited in the city of Santa Cruz (Bolivia) and evaluated at the Hospital Nacional de niños in Santa Cruz August 2014. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of range of motion of elbow, knee and ankle
We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia
Measured: Screening visit
Assessment of muscle strength of arm, thigh and leg
We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia
Measured: Screening visit
Assessment of perception of joint pain
We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).
Measured: Screening visit
Assessment of the status joint
We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status
Measured: Screening visit
Evaluation of the performance of activities of daily living
We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
Measured: Screening visit
Assessment of physical performance of patients with hemophilia
We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
Measured: Screening visit
Assessment of personality traits of children
We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
Measured: Screening visit
Evaluation of perceived quality of life for patients with hemophilia
We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .
Measured: Screening visit
Secondary outcomes (2)
Clinical variables of patients with hemophilia
Age (years); weight (kg); Size (cm); type of haemophilia (A or B); severity of hemophilia (severe / moderate / mild); pharmacological treatment (prophylactic / on demand); presence of inhibitors; central venous catheter; family history of hemophilia; hemarthrosis in the last month; arthropathy diagnosed in some joint; use of orthoses
Measured: Screening visit
Socio-demographic variables of patients with hemophilia
Number of hospital visits per year (reason); Distance to hospital (km); Academic formation of the patient (university studies / vocational training / basic studies / no studies); academic formation of the parents (university studies / vocational training / basic studies / no studies); patient employment (self-employment / employment has as an employed person / unemployed / retirement); parents employment (self-employment / employment has as an employed person / unemployed / retirement);
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 posted24 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia
- Investigators
- RUBEN CUESTA-BARRIUSO, PhD, Principal investigator, Universidad Católica San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199639
- Sponsor's protocol ID
- ibHEro
- Other IDs
- ibHEro
- Acronym
- ibHEro
- Status last verified
- Mar 2014
- First submitted
- 23 Jul 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
- ClinicalTrials.gov ID
- NCT02199639
- Acronym / sponsor ID
- ibHEro / ibHEro
- Conditions
- Patients With Haemophilia
- Keywords
- Haemophilia, Arthropathy, Range of Movement, Strength, Proprioception, Gait, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 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.
Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain, El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the degree of injury, age, presence of inhibitors and the development of physical activity; identify the relationship between the functional deficit by clinical assessment performed with the use of validated measurement scales, the assessment of the degree of injury to specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their impact on gait in patients with hemophilia; and evaluate the factors that influence the perception of illness and quality of life of patients with hemophilia.
Detailed description
Descriptive study of joint involvement in patients with hemophilia Spain, El Salvador and Bolivia.
Descriptive study of abnormal joint mobility and muscle strength as a result of acute conditions or the development of chronic articular sequelae.
Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.
Descriptive study of the overall articular involvement (crepitus, pain, biomechanical and functional changes) in patients with hemophilia.
Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perception of it, and their quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spain | – | –Group of patients with hemophilia recruited in the Region of Murcia (Spain) and evaluated in the Universidad Católica San Antonio between June and July 2014. |
| El Salvador | – | –Group of patients with hemophilia recruited in the city of San Salvador (El Salvador) and evaluated in the Hospital Nacional Rosales and the Hospital Nacional de niños "Benjamín Bloom" from San Salvador in April 2014. |
| Bolivia | – | –Group of patients with hemophilia recruited in the city of Santa Cruz (Bolivia) and evaluated at the Hospital Nacional de niños in Santa Cruz August 2014. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia from Spain, El Salvador and Bolivia
Key inclusion criteria (4 listed)
- Patients with hemophilia A and B.
- Patients of all ages (pediatric, adolescents, youth and adults).
- With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
- Patients with or without inhibitors.
Key exclusion criteria (3 listed)
- Patients without prior ambulation capacity.
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
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
Assessment of range of motion of elbow, knee and ankle
Time frame: Screening visit
We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia
Assessment of muscle strength of arm, thigh and leg
Time frame: Screening visit
We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia
Assessment of perception of joint pain
Time frame: Screening visit
We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).
Assessment of the status joint
Time frame: Screening visit
We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status
Evaluation of the performance of activities of daily living
Time frame: Screening visit
We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
Assessment of physical performance of patients with hemophilia
Time frame: Screening visit
We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
Assessment of personality traits of children
Time frame: Screening visit
We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
Evaluation of perceived quality of life for patients with hemophilia
Time frame: Screening visit
We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .
2 secondary outcomes
Clinical variables of patients with hemophilia
Time frame: Screening visit
Socio-demographic variables of patients with hemophilia
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 30 Apr 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.
RUBEN 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 Patients With Haemophilia, run by Universidad Católica San Antonio 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 4 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 30 Apr 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 RUBÉN CUESTA-BARRIUSO, PhD (968278806, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of range of motion of elbow, knee and ankle (time frame: Screening visit). The study lists 8 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 30 Apr 2015.