Working… Menu

Socialization of Adult Men With Congenital Hemophilia A or B (PWBCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510418
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : August 3, 2016
Brigham and Women's Hospital
Information provided by (Responsible Party):
Aric Parnes, Dana-Farber Cancer Institute

Brief Summary:
The goal of this pilot study is to understand the socialization of adult men with hemophilia living in the United States and their quality of life in order to improve comprehensive care for persons with congenital bleeding disorders. Studies in Europe suggest that despite medical, surgical, and biotechnology advances in care for persons with the congenital bleeding disorders hemophilia A and B, men with hemophilia have earlier work disability and health-related lower quality of life than men of the same age who do not have hemophilia in the general population. Congenital bleeding disorders are known to have medical and psychosocial impact not only in school but also in other activities, e.g. participation in sports beginning at a young age. The psychosocial impact of living with a congenital bleeding disorder has been studied and described in childhood. The support relationships in childhood include parents and primary family of origin and these supports are generally considered in pediatric comprehensive care models. Support relationships in adulthood have not been well described or studied. The role of spouse and significant others (SSO) of PWCBD in health care is of interest for the delivery of adult comprehensive care as well as to understand their contribution to the health-related quality of life of PWCBD. Additionally, this study seeks to learn of the impact of congenital bleeding disorders for the SSO. The study uses self-reported medical and social information questionnaires, health-related quality of life surveys, and confidential interview. Results of this study may guide how comprehensive care and support are provided to adult persons with congenital bleeding disorders by hemophilia treatment programs. This study focuses on PWCBD with hemophilia A or B as a model for the experience of persons with other congenital bleeding disorders.

Condition or disease
Hemophilia A Hemophilia B

Detailed Description:

There are two groups (cohorts) in this study. One group is adult men with congenital hemophilia A or B who qualify for the study. The other group is their spouse or significant other (SSO) who are voluntarily identified by the person with congenital bleeding disorder for recruitment into the study.

For the adult men with congenital hemophilia A or B, the study involves a minimum of 2 visits and includes screening, medical history and physical exam review, completing confidential questionnaires and interview.

Eligible men with congenital hemophilia A or B (person with congenital bleeding disorder, PWCBD) are given the option to permit the investigator to contact their spouse or significant other (SSO) for participation in the study. If PWCBD has an SSO, the SSO is not required to participate in the study.

Spouse/significant other(SSO)of men with congenital hemophilia A or B may enter the study only if they have been voluntarily identified by their partner (PWCBD) and their partner has opted to allow investigator to contact them. For the SSO who chooses to participate in the study, the study will involve a minimum of one visit and includes completing confidential questionnaires and interview.

All participation including questionnaires and interview information collected is confidential and protected by health privacy information laws and records are de-identified.

The study is sponsored by a grant from The National Hemophilia Foundation.

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Socialization of Adult Men With Congenital Hemophilia A or B: A Study to Examine Socialization Measures, the Role of Spouse/Significant Other and Health Related Quality of Life
Study Start Date : May 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Person with congenital bleeding disorder
Adult men with congenital hemophilia A or B
Spouse/Significant Other
Spouse/significant other of person with congenital bleeding disorder participating in this study.

Primary Outcome Measures :
  1. Health related quality of life, description of support and networks. [ Time Frame: 2 years ]
    Standard health-related quality of life questionnaires and interview are used to obtain primary outcome measure about PWCBD.

Secondary Outcome Measures :
  1. Quality of life and description of role of SSO in health care of their PWCBD partner [ Time Frame: 2 years ]
    Standardized quality of life questionnaire, social-medical questionnaire and interview of SSO are used to obtain this outcome measure.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

There are two study populations:

PWCBD: Person with congenital bleeding disorders are adult men with congenital hemophilia A or B who receive care in Massachusetts or who reside in the New England area or elsewhere and are willing to travel to the study site may be eligible for recruitment.


Eligibility criteria for person with congenital bleeding disorder(PWCBD, men with congenital hemophilia):

  • Known diagnosis of congenital hemophilia A or B with or without inhibitor (defined by a plasma factor VIII or factor IX level below lower limits of normal and medical history consistent with diagnosis).
  • Male age 21 years or older
  • Willing to indicate if they have a spouse or significant other.
  • Able to read, write and participate in interview on site.

Exclusion Criteria for PWCBD:

  • Other bleeding disorder besides congenital hemophilia A or B

Eligibility criteria for spouses/significant other (SSO) participants in the study:

  • A person in a relationship for a minimum of 9 months with the PWCBD participating in the study.
  • PWCBD partner must be participating in the study.
  • Willing to participate in questionnaire and interview on site.

Exclusion criteria for SSO:

- Biologically related to PWCBD participant (that is, not a parent, sibling, child or other biologically-related caregiver).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01510418

Layout table for location information
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Layout table for investigator information
Principal Investigator: Aric Parnes, MD Brigham and Women's Hospital

Layout table for additonal information
Responsible Party: Aric Parnes, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01510418     History of Changes
Other Study ID Numbers: 10-343
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Aric Parnes, Dana-Farber Cancer Institute:
Significant Other
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hemophilia A
Hemophilia B
Factor VIII