Hemophilia APWBCDNCT01510418
Socialization of Adult Men With Congenital Hemophilia A or B
An observational study of Hemophilia A and Hemophilia B, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemophilia A, Hemophilia B
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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.
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Hemophilia, Spouse, Significant Other, Quality of Life
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Quality of life and description of role of SSO in health care of their PWCBD partner
Standardized quality of life questionnaire, social-medical questionnaire and interview of SSO are used to obtain this outcome measure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Aric Parnes, Dana-Farber Cancer Institute
- Investigators
- Aric Parnes, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510418
- Sponsor's protocol ID
- 10-343
- Acronym
- PWBCD
- Status last verified
- Aug 2016
- First submitted
- 3 Oct 2011
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01510418
- Acronym / sponsor ID
- PWBCD / 10-343
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Hemophilia, Spouse, Significant Other, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Other bleeding disorder besides congenital hemophilia A or B
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quality of life and description of role of SSO in health care of their PWCBD partner
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aric Parnes, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life, description of support and networks. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.