Adherence to Treatment in Hemophilia

NCT02191436

Last updated date
Study Location
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , 30120, Spain
Contact
868887170

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Haemophilia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with hemophilia A or B

- Patients followed at the Hematology Department of the hospitals included in the study

- Patients without cognitive disorders

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with other congenital coaguopatías


- Patients with more than 2 years without going to review your hospital


- Patients from other provinces of Spain

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Advanced Information
Descriptive Information
Brief Title Adherence to Treatment in Hemophilia
Official Title Psychosocial Factors and Adherence to Treatment in Patients With Hemophilia. A Multicenter Study
Brief Summary Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families
Detailed Description

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]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with haemophilia treated at the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia, and the Hospital Clínico Universitario Carlos Haya (Málaga)
Condition Haemophilia
Intervention Not Provided
Study Groups/Cohorts Patients with haemophilia
Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 15, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with hemophilia A or B
  • Patients followed at the Hematology Department of the hospitals included in the study
  • Patients without cognitive disorders

Exclusion Criteria:

  • Patients with other congenital coaguopatías
  • Patients with more than 2 years without going to review your hospital
  • Patients from other provinces of Spain
Sex/Gender
Sexes Eligible for Study:Male
Ages 6 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02191436
Other Study ID Numbers ADHERENCE
ADHE ( Other Identifier: UMU )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ANA TORRES-ORTUÑO, Universidad de Murcia
Study Sponsor ANA TORRES-ORTUÑO
Collaborators Pfizer
Investigators
Principal Investigator:RUBÉN CUESTA-BARRIUSO, PhDUNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
PRS Account Universidad de Murcia
Verification Date September 2015