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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


N/A
21 Years
N/A
Open (Enrolling)
Both
Hemophilia A, Hemophilia B

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Trial Information

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


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.

Inclusion Criteria


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Judith C Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

10-343

NCT ID:

NCT01510418

Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Hemophilia A
  • Hemophilia B
  • Hemophilia
  • Spouse
  • Significant Other
  • Quality of Life
  • Hemophilia B
  • Hemophilia A

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115