Evaluating a Preventive Heart Health Programme for Women at Midlife

Cardiovascular Disease Clinical Trial

— Phenomenon  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05967000
• Other study ID #: 2022/00350
• Secondary ID: NUS/BISI/SG02/20
• Status: Active, not recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Alexandra Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Menopause

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Singapore	Alexandra Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Alexandra Hospital	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Implementation of the programme	This will be measured as counts from clinic visits	1 year
Secondary	Anthropometric measurements	Weight and height will be combined to report BMI in kg/m^2	1 year
Secondary	Blood pressure	Office blood pressure measurements	1 year
Secondary	Blood biomarkers	Hba1c	1 year
Secondary	Blood biomarkers	Lipid profile	1 year
Secondary	Blood biomarkers	Vitamin D levels	1 year
Secondary	Surveys	Semi structure interviews will be conducted and analysed via reflexive thematic approach.	At the end of the study at 1 year