Transcultural Multidisciplinary Evaluation of Patients With Hemophili

Patients With Haemophilia Clinical Trial

— ibHEro  

Official title:

Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02199639
• Other study ID #: ibHEro
• Secondary ID: ibHEro
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2014
• Last updated: April 29, 2015
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Universidad Católica San Antonio de Murcia
• Contact: RUBÉN CUESTA-BARRIUSO, PhD
• Phone: 968278806
• Email: ruben.cuestab[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemophilia A
• Patients With Haemophilia

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Screening visit	No
Primary	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	Screening visit	No
Primary	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).	Screening visit	No
Primary	Assessment of the status joint	We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status	Screening visit	No
Primary	Evaluation of the performance of activities of daily living	We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia	Screening visit	No
Primary	Assessment of physical performance of patients with hemophilia	We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia	Screening visit	No
Primary	Assessment of personality traits of children	We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)	Screening visit	No
Primary	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 .	Screening visit	No
Secondary	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	Screening visit	No
Secondary	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);	Screening visit	No