- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05967000
Evaluating a Preventive Heart Health Programme for Women at Midlife (Phenomenon)
Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 159964
- Alexandra Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women at midlife
Women aged 45-65 years with risk factors or pre-existing CVD
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
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)
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
Implementation of the programme
Time Frame: 1 year
|
This will be measured as counts from clinic visits
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric measurements
Time Frame: 1 year
|
Weight and height will be combined to report BMI in kg/m^2
|
1 year
|
Blood pressure
Time Frame: 1 year
|
Office blood pressure measurements
|
1 year
|
Blood biomarkers
Time Frame: 1 year
|
Hba1c
|
1 year
|
Blood biomarkers
Time Frame: 1 year
|
Lipid profile
|
1 year
|
Blood biomarkers
Time Frame: 1 year
|
Vitamin D levels
|
1 year
|
Surveys
Time Frame: At the end of the study at 1 year
|
Semi structure interviews will be conducted and analysed via reflexive thematic approach.
|
At the end of the study at 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/00350
- NUS/BISI/SG02/2022 (Other Grant/Funding Number: NUS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
National Human Genome Research Institute (NHGRI)Active, not recruiting
-
AmgenCompletedCardiovascular DiseaseUnited States, Australia
-
VA Office of Research and DevelopmentEnrolling by invitationCardiovascular DiseaseUnited States
Clinical Trials on Preventive heart health and menopause programme
-
National University Hospital, SingaporeNational University of SingaporeUnknownCardiovascular DiseaseSingapore
-
University of SalamancaNot yet recruitingQuality of Life | Cancer | Dyspnea | Functional Capacity | FunctionalitySpain
-
University of RochesterDartmouth-Hitchcock Medical Center; Association for the Blind and Visually...Completed
-
Fundació Institut de Recerca de l'Hospital de la...UnknownHeart Transplant
-
Chinese University of Hong KongCompletedDiabetes Mellitus, Type 2China
-
Little Lions Child CoachingKing's College London; University of Cape TownNot yet recruiting
-
University of HawaiiCompleted
-
University of SalamancaNot yet recruitingOccupational Therapy | Intervention | Family Caregiver | Psychology | Dependent Older People | Interdisciplinary | PsychoeducationalSpain
-
American Heart AssociationIntel CorporationCompleted