Socialization of Adult Men With Congenital Hemophilia A or B (PWBCD)
|Hemophilia A Hemophilia B|
|Study Design:||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|
- 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.
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Person with congenital bleeding disorder
Adult men with congenital hemophilia A or B
Spouse/significant other of person with congenital bleeding disorder participating in this study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510418
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Aric Parnes, MD||Brigham and Women's Hospital|