Socialization of Adult Men With Congenital Hemophilia A or B
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2011 |
| End Date: | December 2013 |
| Contact: | Judith C Lin, MD |
| Email: | PWCBDstudy@partners.org |
| Phone: | 617-732-5190 |
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
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.
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.
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.
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.
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).
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