Socialization of Adult Men With Congenital Hemophilia A or B

NCT01510418 | Completed DMC

• 1 other identifier: 10-343
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A; Hemophilia B

Keywords

Hemophilia; Spouse; Significant Other; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Health related quality of life, description of support and networks.

  Standard health-related quality of life questionnaires and interview are used to obtain primary outcome measure about PWCBD.

  2 years

Secondary Outcomes (1)

• Quality of life and description of role of SSO in health care of their PWCBD partner

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Aric Parnes, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: January 16, 2012
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

US (1)