Evaluating a Preventive Heart Health Programme for Women at Midlife

Active, not recruiting

• Conditions: Cardiovascular Disease; Menopause
• Interventions: Other: Preventive heart health and menopause programme

• Registration Number: NCT05967000
• Lead Sponsor: Alexandra Hospital

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-30
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women at midlife	Preventive heart health and menopause programme	Women aged 45-65 years with risk factors or pre-existing CVD

Primary Outcome Measures

Name	Time	Method
Implementation of the programme	1 year	This will be measured as counts from clinic visits
Effectiveness of the programme	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	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	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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1 year	Office blood pressure measurements
Surveys	At the end of the study at 1 year	Semi structure interviews will be conducted and analysed via reflexive thematic approach.
Anthropometric measurements	1 year	Weight and height will be combined to report BMI in kg/m\^2
Blood biomarkers	1 year	Vitamin D levels

Trial Locations

Locations (1)

Alexandra Hospital; 🇸🇬 Singapore, Singapore