Evaluating a Preventive Heart Health Programme for Women at Midlife

NCT ID: NCT05967000

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Cardiovascular Disease; Menopause

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Women at midlife

Women aged 45-65 years with risk factors or pre-existing CVD

Preventive heart health and menopause programme

Intervention Type: OTHER

This is a one-stop women's heart and menopausal service in a public hospital led by cardiologists and gynaecologists with a multidisciplinary team. Pre-existing speciality care and services are repackaged, and clinic workflows are reworked to provide more streamlined, convenient, and integrated care. Services encompass:

• Individualised risk assessment, screening, diagnosis, and treatment of CVD.
• Lifestyle education, adjustment, stress management, and counselling.
• Smoking cessation programs.
• Bone health screening, mammogram with access to our co-located gynaecologists and hormone replacement therapy.
• Virtual consults and health coaching.

Interventions

Preventive heart health and menopause programme

This is a one-stop women's heart and menopausal service in a public hospital led by cardiologists and gynaecologists with a multidisciplinary team. Pre-existing speciality care and services are repackaged, and clinic workflows are reworked to provide more streamlined, convenient, and integrated care. Services encompass:

• Individualised risk assessment, screening, diagnosis, and treatment of CVD.
• Lifestyle education, adjustment, stress management, and counselling.
• Smoking cessation programs.
• Bone health screening, mammogram with access to our co-located gynaecologists and hormone replacement therapy.
• Virtual consults and health coaching.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Alexandra Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexandra Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NUS/BISI/SG02/2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022/00350

Identifier Type: -

Identifier Source: org_study_id