- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00345072
A Menopause Interactive Decision Aid System
연구 개요
상세 설명
Most women are not satisfied with the counseling they receive about menopause. To improve menopause counseling and help menopausal women more actively participate in the decision making process, we have developed a novel prototype web-based decision aid. Our immediate goal is to develop this prototype technology into a comprehensive Menopause Interactive Decision Aid System (MIDAS) that provides personalized feedback about menopausal symptoms, risks for common conditions, and the effects of different treatment options on the short- and long-term consequences of menopause.
Our main study hypotheses are that MIDAS can: 1) lead to better decisions and improve the quality of menopausal counseling; 2) improve compliance with a chosen menopausal plan; and 3) reduce medical errors associated with the use of menopausal therapies.
We propose a 2-phase study conducted over 3 years. Phase I will transform the prototype application into a comprehensive MIDAS, completing its content and risk assessment instruments, and exploring its optimal design. This will be accomplished through conduct of focus groups and usability tests. Phase II will formally evaluate the impact of MIDAS in a randomized, controlled, multi-center clinical trial involving diverse patient populations and clinician settings. We will measure the impact of MIDAS on the decision-making process as well as its effect on providers and outcome measures related to menopause, including compliance, quality of life, and medical errors related to menopausal therapy. Analyses will evaluate the extent to which the impact of MIDAS on these outcomes varies according to patient, practice, and physician characteristics.
연구 유형
등록
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02120
- Brigham and Women's Hospital
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- English-speaking
- Between 45 and 65 years of age
- Patient at participating clinics
- Experience menopausal symptoms or being 6 months or more past last menstrual period
- Have an upcoming appointment for menopausal counseling or annual physical exam (only applicable for clinical trial participants)
Exclusion Criteria:
- Inability to give informed consent
- Dementia
- Age over 65 years
- Pre-existing terminal illness that limits life expectancy to less than 2 years
- History of breast cancer or cardiovascular disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 교육/상담/훈련
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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우울증
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불안
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건강 관련 삶의 질
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결정적 충돌
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Knowledge of the benefits, risks and side effects of menopausal treatments
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Risk perception for breast cancer, CHD, and hip fracture
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Patient-physician communication
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Satisfaction with decision
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Quality of menopausal counseling
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Adherence to medication and lifestyle changes
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Menopause-specific quality of life
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nananda F Col, MD, MPH, MPP, Rhode Island Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
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 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. .