- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Health related quality of life, description of support and networks.
기간: 2 years
|
Standard health-related quality of life questionnaires and interview are used to obtain primary outcome measure about PWCBD.
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of life and description of role of SSO in health care of their PWCBD partner
기간: 2 years
|
Standardized quality of life questionnaire, social-medical questionnaire and interview of SSO are used to obtain this outcome measure.
|
2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Aric Parnes, MD, Brigham and Women's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10-343
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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