Socialization of Adult Men With Congenital Hemophilia A or B

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01510418

Acronym

PWBCD

Enrollment

Registered

2012-01-16

Start date

2011-05-31

Completion date

2013-12-31

Last updated

2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A, Hemophilia B

Keywords

Hemophilia, Spouse, Significant Other, Quality of Life

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Health related quality of life, description of support and networks.	2 years	Standard health-related quality of life questionnaires and interview are used to obtain primary outcome measure about PWCBD.

Secondary

Measure	Time frame	Description
Quality of life and description of role of SSO in health care of their PWCBD partner	2 years	Standardized quality of life questionnaire, social-medical questionnaire and interview of SSO are used to obtain this outcome measure.

Countries

United States

Outcome results