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Trial record 1 of 1 for:    NCT02191436
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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ANA TORRES-ORTUÑO, Universidad de Murcia

Tracking Information
First Submitted Date July 14, 2014
First Posted Date July 16, 2014
Last Update Posted Date October 20, 2015
Study Start Date May 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2014)
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, PhD UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
PRS Account Universidad de Murcia
Verification Date September 2015