Clinical trial NCT04715100: Pain and Joint Status With Psychosocial Factors in Patients With Hemophilia
Official title: Relationship of Pain and Joint Status With the Perception of Psychosocial Factors in Patients With Hemophilic Arthropathy: A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia Arthropathy
Keywords: Hemophilic arthropathy
Educational intervention
Joint pain
Quality of life
Anxiety
Stress
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2021-01-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia attending in hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).

Brief summary: Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Disability and functional limitations are characteristic sequelae of these patients from an early age.

Objective. To assess the joint status, the perception of quality of life, the performance of roles and the performance of daily life activities, in patients with hemophilic arthropathy.

Study design. Observational, multicenter study. Method. 70 patients with hemophilia A and B will be included in this study. Patients will be recruited from 4 centers in different regions of Spain. The dependent variables will be: pain (measured with the Visual Analogue Scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles, performance of daily life activities (Barthel scale), performing the instrumental activities of daily life (Lawton and Brody scale). The evolution of the variables will be analyzed using parametric (t-student or ANOVA) or non-parametric (Wilcoxon or Friedman) tests. A correlation analysis will be carried out between the dependent and independent variables, as well as a linear regression analysis between the observed determining variables.

Expected results. The aim is to observe the relationship of pain and joint status in patients with hemophilic arthropathy, with their perception of quality of life, the development of the roles they play and the performance of basic and instrumental activities of daily living.

Detailed description: Main objective: To analyze the relationship of pain and joint status with psychosocial and functional variables in adult patients with hemophilic arthropathy.

Secondary objectives: i) To detect the relationship between joint damage in psychosocial disorders in patients with hemophilia; ii) Evaluate the performance and perception of roles with the clinical situation of patients with hemophilic arthropathy; iii) Identify the factors that influence the performance of basic and instrumental activities of daily living in adult patients with hemophilia; iv) Observe changes in the perception of quality of life, performance of roles and activities of daily life based on the clinical and sociodemographic characteristics of patients with hemophilia.

Patients who meet the selection criteria will be summoned to a meeting where the principal investigator will present, orally and in writing, the characteristics of the investigator, the intended objectives and the risks of the intervention. At said meeting, the following documentation will be provided: patient information document and informed consent document for patients.

After obtaining the informed consent of the patients, the evaluations will be carried out in the dependencies of the locations included in the study. Six dependent variables will be measured: pain, joint condition, perception of quality of life, list of roles, performance of basic activities of daily life, and performance of instrumental activities of daily life.

All joint state evaluations will be performed by the same physiotherapist, blinded to the objectives of the study. The evaluation of the questionnaires will be analyzed by another evaluator, blinded to the objectives of the study.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Patients of legal age
* Patients on prophylactic or on demand treatment with clotting factor concentrates.

Exclusion Criteria:

* Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
* Dependent patients who require help from a third person to get around
* Patients who have developed a hemarthros in the 4 weeks prior to the study.
* Patients who have not signed the informed consent document.

Primary outcomes:
measure: Assess the perception of joint pain with numerical scale of pain
timeFrame: Screening visit
measure: Assess the joint status with Hemophilia Joint Health Score
timeFrame: Screening visit
Secondary outcomes:
measure: Assess the perception of quality of life with the questtionaire Short Form 36 Health Survey
timeFrame: Screening visit
measure: Assess the list of roles with Oakley scale
timeFrame: Screening visit
measure: Assess the carrying out activities of daily living
timeFrame: Screening visit
measure: Assess the instrumental activities of daily living
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: University of Murcia
Study officials:
affiliation: Universidad de Murcia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: