Adherence to Treatment in Hemophilia (ADHERENCE)
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|ClinicalTrials.gov Identifier: NCT02191436|
Recruitment Status : Unknown
Verified September 2015 by ANA TORRES-ORTUÑO, Universidad de Murcia.
Recruitment status was: Recruiting
First Posted : July 16, 2014
Last Update Posted : October 20, 2015
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||February 2016|
Patients with haemophilia
Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18
- 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).
- Assess the clinical data of the patient [ Time Frame: Screening visit ]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
- Assess the demographic data of the patient [ Time Frame: Screening visit ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191436
|Contact: ANA TORRES-ORTUÑO, PhDfirstname.lastname@example.org|
|Contact: RUBÉN CUESTA-BARRIUSO, PhDemail@example.com|
|Principal Investigator:||RUBÉN CUESTA-BARRIUSO, PhD||UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA|