跳至主要内容
临床试验/NCT05967000
NCT05967000进行中(未招募)不适用

Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.

Alexandra Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Implementation of the programme

研究概览

简要总结

This study examines the factors that limit or support the implementation of a pilot heart health program for perimenopausal women. The investigators evaluate the effectiveness of this program in raising awareness and promoting behavior change to maintain cardiovascular health.

详细描述

Cardiovascular disease (CVD) is the leading cause of mortality among women. Heart-related conditions are responsible for the death of one out of every three women. In Singapore, CVD in women causes more morbidity and mortality than breast and cervical cancer. The burden will be exacerbated by Singapore's aging population and the longer life expectancy of women compared to men. Primary and secondary prevention strategies are implemented to reduce the overall impact of CVD on public health. Women who have traditional risk factors are at a greater risk of experiencing heart attacks compared to men with comparable risk factors. Additional risks specific to women include a history of pregnancy complications, breast cancer, and premature menopause. CVDs in women are frequently overlooked in terms of diagnosis and treatment.

Menopause is a phase in a woman's life that brings about significant changes to both her reproductive organs and her physical and psychological well-being. Management issues encompass a spectrum of concerns, including immediate symptoms like insomnia and palpitations, intermediate concerns related to bone health, and long-term considerations associated with the development of cardiovascular disease. The American Heart Association (AHA) provides guidelines for multidisciplinary care aimed at preventing cardiovascular disease (CVD) in women. Countries like Canada have established specialized organizations to address this issue. Collaborative clinics involving cardiologists, gynecologists, and women's heart centers are crucial, even for women who are generally healthy.

The objective of this study is to examine the factors that limit or support the implementation of a preventive heart health program for perimenopausal women. Additionally, the investigators aim to evaluate the effectiveness of our pilot women's health program in raising awareness and promoting behavior change to maintain cardiovascular health.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 45-65 years at risk for cardiovascular disease or with pre-existing cardiovascular disease.
  • English speaking

排除标准

  • Pregnant women
  • Unable to provide informed consent
  • Women out of the menopause transition phase of 45-65 years of age.

结局指标

主要结局

Implementation of the programme

时间窗: 1 year

This will be measured as counts from clinic visits

Effectiveness of the programme

时间窗: 1 year

This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the Utian Quality of life scale.

Adoption of the programme

时间窗: 1 year

This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via qualitative interviews to assess whether healthcare providers are accepting of the intervention and can sustain the change.

Reach of the programme

时间窗: 1 year

This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via participation rate which is the number of eligible women recruited (numerator) divided by the number of eligible women screened for the programme (denominator

次要结局

  • Blood pressure(1 year)
  • Surveys(At the end of the study at 1 year)
  • Anthropometric measurements(1 year)
  • Blood biomarkers(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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