ibHEro: Transcultural Multidisciplinary Evaluation of Patients With Hemophili

Sponsor

Universidad Católica San Antonio de Murcia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02199639

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Haemophilia

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Assessment of range of motion of elbow, knee and ankle [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 [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 [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 [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 [Screening visit]
We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
Assessment of physical performance of patients with hemophilia [Screening visit]
We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
Assessment of personality traits of children [Screening visit]
We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
Evaluation of perceived quality of life for patients with hemophilia [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 .

Secondary Outcome Measures

Clinical variables of patients with hemophilia [Screening visit]
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
Socio-demographic variables of patients with hemophilia [Screening visit]
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);

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.