Cardiovascular DiseasePhenomenonNCT05967000
Evaluating a Preventive Heart Health Programme for Women at Midlife
An observational study of Cardiovascular Disease and Menopause, run by Alexandra Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Cardiovascular Disease, Menopause
- What is being tested?
- Preventive heart health and menopause programme
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women going through the menopause transition with risk factors for CVD or pre-existing CVD.
Who may be able to join
- Women aged 45-65 years at risk for cardiovascular disease or with pre-existing cardiovascular disease.
- English speaking
Who cannot join
- Pregnant women
- Unable to provide informed consent
- Women out of the menopause transition phase of 45-65 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.
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.
Read the 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
- Being tested
- Preventive heart health and menopause programme
- Keywords
- preventive cardiology, menopause, implementation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive heart health and menopause programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Women at midlife | Women aged 45-65 years with risk factors or pre-existing CVD Receives: Other: Preventive heart health and menopause programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 1 year
Implementation of the programme
This will be measured as counts from clinic visits
Measured: 1 year
Secondary outcomes (6)
Anthropometric measurements
Weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Blood pressure
Office blood pressure measurements
Measured: 1 year
Blood biomarkers
Hba1c
Measured: 1 year
Blood biomarkers
Lipid profile
Measured: 1 year
Blood biomarkers
Vitamin D levels
Measured: 1 year
Surveys
Semi structure interviews will be conducted and analysed via reflexive thematic approach.
Measured: At the end of the study at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967000
- Sponsor's protocol ID
- 2022/00350
- Other IDs
- NUS/BISI/SG02/2022
- Acronym
- Phenomenon
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang GSH, Tan CPT, Tioh CML, Lee EWX, Wang LY. Evaluating a Preventive Heart Health Program for Women at Midlife: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2026 May 25;15:e83574. doi: 10.2196/83574.
PubMed 42184360
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.
- ClinicalTrials.gov ID
- NCT05967000
- Acronym / sponsor ID
- Phenomenon / 2022/00350
- Conditions
- Cardiovascular Disease, Menopause
- Keywords
- preventive cardiology, menopause, implementation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women at midlife | – | Other: Preventive heart health and menopause programmeWomen aged 45-65 years with risk factors or pre-existing CVD |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women going through the menopause transition with risk factors for CVD or pre-existing CVD.
Key inclusion criteria (2 listed)
- Women aged 45-65 years at risk for cardiovascular disease or with pre-existing cardiovascular disease.
- English speaking
Key exclusion criteria (3 listed)
- Pregnant women
- Unable to provide informed consent
- Women out of the menopause transition phase of 45-65 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive heart health and menopause programmeThis 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. | Other | Women at midlife |
Primary outcome
Reach of the programme
Time frame: 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
Effectiveness of the programme
Time frame: 1 year
This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire)
Effectiveness of the programme
Time frame: 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
Time frame: 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.
Implementation of the programme
Time frame: 1 year
This will be measured as counts from clinic visits
6 secondary outcomes
Anthropometric measurements
Time frame: 1 year
Blood pressure
Time frame: 1 year
Blood biomarkers
Time frame: 1 year
Blood biomarkers
Time frame: 1 year
Blood biomarkers
Time frame: 1 year
Surveys
Time frame: At the end of the study at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 42184360Chiang GSH, Tan CPT, Tioh CML, Lee EWX, Wang LY. Evaluating a Preventive Heart Health Program for Women at Midlife: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2026 May 25;15:e83574. doi: 10.2196/83574.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Menopause, run by Alexandra Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of the programme (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.