NCT02191436

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 20, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

July 14, 2014

Last Update Submit

October 19, 2015

Conditions

Haemophilia

Keywords

HaemophiliaAdherenceFamily FunctioningQuality of LifeAnxietyIllness BehaviorCoping Strategies

Outcome Measures

Primary Outcomes (9)

  • Assess the perception of quality of life

    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.

    Screening visit

  • Assess the perception of illness of the patients

    To measure this variable we use the Illness Perception Questionnaire Revised (IPQ-R).

    Screening visit

  • Assess anxiety of patients and parents of children with hemophilia.

    To evaluate this variable we use the State-Trait Anxiety Inventory (STAI)

    Screening visit

  • To assess illness behavior of patients.

    To assess this variable we use the illness behaviour questionnaire (IBQ).

    Screening visit

  • Assessing coping strategies of patients.

    To assess this variable we use the Coping Scale questionnaire.

    Screening visit

  • Assess the perception of family functioning of parents of children with hemophilia

    To assess this variable we use the Family Functioning Evaluation Scale (FACES III).

    Screening visit

  • Assess the perceived stress of parents of children with hemophilia.

    To assess this variable we use the Pediatric Inventory for Parents (PIP).

    Screening visit

  • Assessing the personality traits of children with hemophilia.

    To assess this variable we use the Eysenck Personality Questionnaire Junior (EPQ-J)

    Screening visit

  • Assess adherence to treatment of patients with hemophilia.

    To assess this variable we use the Beliefs About Medication Questionnaire (BMQ).

    Screening visit

Secondary Outcomes (2)

  • Assess the clinical data of the patient

    Screening visit

  • Assess the demographic data of the patient

    Screening visit

Study Arms (1)

Patients with haemophilia

Hemophilia patients (children, youth and adults) and parents of children with hemophilia under 18

Eligibility Criteria

Age6 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

  • Patients with other congenital coaguopatías
  • Patients with more than 2 years without going to review your hospital
  • Patients from other provinces of Spain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia AAnxiety DisordersIllness Behavior

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMental DisordersBehavior

Study Officials

  • RUBÉN CUESTA-BARRIUSO, PhD

    UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANA TORRES-ORTUÑO, PhD

CONTACT

868887170atorres.ortuno@gmail.com

RUBÉN CUESTA-BARRIUSO, PhD

CONTACT

968278806ruben.cuestab@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

October 20, 2015

Record last verified: 2015-09

Locations

ES(1)