Clinical trial NCT05967000: Evaluating a Preventive Heart Health Programme for Women at Midlife
Official title: Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Disease
Menopause
Keywords: preventive cardiology
menopause
implementation
Lead sponsor: Alexandra Hospital
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
First posted: 2023-08-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women going through the menopause transition with risk factors for CVD or pre-existing CVD.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Reach of the programme
timeFrame: 1 year
measure: Effectiveness of the programme
timeFrame: 1 year
measure: Effectiveness of the programme
timeFrame: 1 year
measure: Adoption of the programme
timeFrame: 1 year
measure: Implementation of the programme
timeFrame: 1 year
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Blood biomarkers
timeFrame: 1 year
measure: Blood biomarkers
timeFrame: 1 year
measure: Blood biomarkers
timeFrame: 1 year
measure: Surveys
timeFrame: At the end of the study at 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
Study officials:
References: