Population-based Cross-sectional Observational Study for a Brazilian Registry of Menopausal Women and Associated Factors Related to Clinical Profile, Socioeconomic Aspects, Social Disparities, Access to Healthcare, Quality of Life, and Knowledge About Menopause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,592
- 试验地点
- 2
- 主要终点
- Proportion of participants aged 35 to 65 classified as being in the menopausal transition or postmenopause.
研究概览
简要总结
The Brazilian Registry of Menopausal Health is a national study aimed to better understand the health and quality of life of participants aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men.
The study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.
详细描述
The Brazilian Registry of Menopausal Health, called EMBRACE STUDY (Endrocrine Mapping in the Broad Range Of Aging and Climateric Experiences), is an observational, cross-sectional, population-based study conducted with the objective of characterizing the epidemiological aspects of the Brazilian population during the menopausal transition and postmenopause, as well as the factors associated with clinical profiles and symptomatology, socioeconomic conditions, social inequalities, access to healthcare services, quality of life, and knowledge about menopause.
The study will include cisgender women and transgender men who have not undergone surgical or hormonal gender reassignment of secondary sexual characteristics, aged between 35 and 65 years, who seek outpatient care in public or private healthcare services.
A total of 1,592 participants will be enrolled, with 617, 509, and 466 participants in the respective age groups of 35-44, 45-54, and 55-65 years, proportionally stratified across the 27 state capitals of Brazil. These age groups will be used solely for the purpose of sample stratification.
Data about transgender men will be collected for exploratory purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women aged between 35 and 65 years attending medical consultation at public and private outpatient health services;
- •Ability to confirm voluntary participation and sign the Informed Consent Form
排除标准
- •Inability to respond to the interview for any reason
- •Suspected or confirmed pregnancy
- •Uncontrolled diabetes
- •Uncontrolled arterial hypertension
- •Uncontrolled thyroid disorders
- •Grade 3 obesity, defined by a BMI equal to or greater than 40.0 kg/m²
- •Diagnosis of psychiatric disorders that may compromise participation in the interview
- •Previous hysterectomy
- •Previous oophorectomy
- •Current use of illicit drugs
结局指标
主要结局
Proportion of participants aged 35 to 65 classified as being in the menopausal transition or postmenopause.
时间窗: Day 1 (during the medical appointment)
Definition of menopausal status. Premenopause: regular menstrual cycles, corresponding to the reproductive period preceding menopause; Menopausal transition: characterized by irregular menstrual cycles and amenorrhea for less than 12 months. Postmenopause: amenorrhea for more than 12 months.
次要结局
- Characterization of lifestyle profile.(Day 1 (during the medical appointment))
- Characterization of the social profile.(Day 1 (during the medical appointment))
- Total score and quantitative domains of the QSM/WHQ questionnaire [Women's Health Questionnaire (WHQ) / Questionário da Saúde da Mulher (QSM); applicable to women aged 45 to 65 years].(Day 1 (during the medical appointment))
- Total score and quantitative domains of the SF-36 questionnaire [36-Item Short-Form Health Survey].(Day 1 (during the medical appointment))
- Total score and quantitative domains of the WPAI-GH questionnaire [WPAI-GH (Work Productivity and Activity Impairment - General Health)].(Day 1 (during the medical appointment))
- Classification of anxiety according to the GAD-7 questionnaire [Generalized Anxiety Disorder scale].(Day 1 (during the medical appointment))
- Classification of depression according to the PHQ-9 questionnaire [Patient Health Questionnaire-9 (PHQ-9)].(Day 1 (during the medical appointment))
- Proportion of participants in each menopausal status.(Day 1 (during the medical appointment))
- Characterization of the clinical profile.(Day 1 (during the medical appointment))
- Characterization of knowledge and self-perception of menopause.(Day 1 (during the medical appointment))
- Characterization of the anthropometric and physiological profile.(Day 1 (during the medical appointment))
- Characterization of General Health Profile.(Day 1 (during the medical appointment))
- Characterization of Laboratory Profile.(Day 1 (during the medical appointment))
- Characterization of the social profile.(Day 1 (during the medical appointment))
- Characterization of the demographic profile.(Day 1 (during the medical appointment))
- Characterization of lifestyle profile.(Day 1 (during the medical appointment))
- Total score and quantitative domains of the QSM/WHQ questionnaire [Women's Health Questionnaire (WHQ) / Questionário da Saúde da Mulher (QSM); applicable to women aged 45 to 65 years].(Day 1 (during the medical appointment))
- Total score and quantitative domains of the SF-36 questionnaire [36-Item Short-Form Health Survey].(Day 1 (during the medical appointment))
- Total score and quantitative domains of the WPAI-GH questionnaire [WPAI-GH (Work Productivity and Activity Impairment - General Health)].(Day 1 (during the medical appointment))
- Classification of anxiety according to the GAD-7 questionnaire [Generalized Anxiety Disorder scale].(Day 1 (during the medical appointment))
- Classification of depression according to the PHQ-9 questionnaire [Patient Health Questionnaire-9 (PHQ-9)].(Day 1 (during the medical appointment))