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Evaluating a Preventive Heart Health Programme for Women at Midlife

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05967000
Acronym
Phenomenon
Enrollment
120
Registered
2023-08-01
Start date
2023-06-01
Completion date
2024-12-31
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Menopause

Keywords

preventive cardiology, menopause, implementation

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.

Interventions

OTHERPreventive 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.

Sponsors

National University Hospital, Singapore
CollaboratorOTHER
Alexandra Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Implementation of the programme1 yearThis will be measured as counts from clinic visits
Reach of the programme1 yearThis 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
Effectiveness of the programme1 yearThis a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire)
Adoption of the programme1 yearThis 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.

Secondary

MeasureTime frameDescription
Blood pressure1 yearOffice blood pressure measurements
Blood biomarkers1 yearHba1c
Anthropometric measurements1 yearWeight and height will be combined to report BMI in kg/m\^2
SurveysAt the end of the study at 1 yearSemi structure interviews will be conducted and analysed via reflexive thematic approach.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026