Evaluating a Preventive Heart Health Programme for Women at Midlife

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease, Menopause

Intervention / Treatment
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* Other: Preventive heart health and menopause programme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women at midlife<br>Women aged 45-65 years with risk factors or pre-existing CVD | Other: Preventive heart health and menopause programme<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of the programme | 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 | 1 year | 
| Effectiveness of the programme | This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire) | 1 year | 
| Effectiveness of the programme | This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the Utian Quality of life scale. | 1 year | 
| Adoption of the programme | 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. | 1 year | 
| Implementation of the programme | This will be measured as counts from clinic visits | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Weight and height will be combined to report BMI in kg/m^2 | 1 year | 
| Blood pressure | Office blood pressure measurements | 1 year | 
| Blood biomarkers | Hba1c | 1 year | 
| Blood biomarkers | Lipid profile | 1 year | 
| Blood biomarkers | Vitamin D levels | 1 year | 
| Surveys | Semi structure interviews will be conducted and analysed via reflexive thematic approach. | At the end of the study at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preventive cardiology, menopause, implementation