Does Menopause Matter?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life Score
研究概览
简要总结
The purpose of this study is to follow a woman's progression through menopause in order to examine the effects on health related quality of life and use of health care resources, and to understand how women are using alternative therapies.
详细描述
Menopause affects every woman as she ages, yet every woman's experience is different. We are seeking to enroll 720 women from the University of Pittsburgh's Division of General Internal Medicine Outpatient practice (GIMO) at all stages of menopause (pre-, peri-, and post-menopausal), between 40 and 65 years old. They will be followed for 5 years as they progress through menopause.
Women will complete yearly questionnaires during their usual doctor's visit (or by phone or online if necessary) regarding general health, menopause and menopausal symptoms, health related quality of life, traditional and alternative therapy use, social support, and attitudes towards menopause and aging.
We will combine this information with information from women's medical charts to look at how menopause and health related quality of life impact the use of health care resources. Additionally, some women may be asked about the use of health care resources, such as doctor's visits, hospitalizations and lab tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 40-65
- •Patients in the University of Pittsburgh General Internal Medicine Oakland Practice
- •Able to complete the Functional Assessment Screening Tablet (a touch-screen survey)
排除标准
- •Refusal to participate
结局指标
主要结局
Health Related Quality of Life Score
时间窗: Baseline survey
The average enrollment scores of the dependent variable HRQOL \[the physical and mental component summaries (PCS and MCS) of the SF-36\] will be compared among women at different stages of menopause using ANOVA. If the HRQOL scores are not normally distributed on the original scale, a transformation is necessary. We will examine the association between both the baseline presence and severity of symptoms (0-4) and HRQOL using regression techniques. The association between the use of HT (yes/no) and HRQOL will be analyzed by ANOVA. The association between the use of CAM and HRQOL will be analyzed by ANOVA. The association between attitudes towards menopause and HRQOL will be analyzed by linear regression. Confounders, including age, comorbid medical conditions, and social support, will be included in the models. A final model examining the impact of all factors on HRQOL will be created using stepwise linear regression.
次要结局
- Menopause Management(Menopausal Status Schema designed from STRAW and SWAN At least yearly Study Questions Menopausal Symptoms Vaginal dryness and hot flashes At least yearly Study Questions HRQOL SF-36 At least yearly CIF Social Support ISEL Yearly Study Questions Attitudes)
研究者
Rachel Hess
MD, MS
University of Pittsburgh