- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01510418
Socialization of Adult Men With Congenital Hemophilia A or B (PWBCD)
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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-
Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Dana-Farber Cancer Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Person with congenital bleeding disorder
Adult men with congenital hemophilia A or B
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Spouse/Significant Other
Spouse/significant other of person with congenital bleeding disorder participating in this study.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Health related quality of life, description of support and networks.
Zeitfenster: 2 years
|
Standard health-related quality of life questionnaires and interview are used to obtain primary outcome measure about PWCBD.
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2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Quality of life and description of role of SSO in health care of their PWCBD partner
Zeitfenster: 2 years
|
Standardized quality of life questionnaire, social-medical questionnaire and interview of SSO are used to obtain this outcome measure.
|
2 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Aric Parnes, MD, Brigham and Women's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 10-343
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