Phenomenon: Evaluating a Preventive Heart Health Programme for Women at Midlife

Sponsor
Alexandra Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05967000
Collaborator
National University Hospital, Singapore (Other)
120
1
19
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Preventive heart health and menopause programme

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

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Women at midlife

Women aged 45-65 years with risk factors or pre-existing CVD

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Effectiveness of the programme [1 year]

    This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire)

  3. 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.

  4. 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.

  5. Implementation of the programme [1 year]

    This will be measured as counts from clinic visits

Secondary Outcome Measures

  1. Anthropometric measurements [1 year]

    Weight and height will be combined to report BMI in kg/m^2

  2. Blood pressure [1 year]

    Office blood pressure measurements

  3. Blood biomarkers [1 year]

    Hba1c

  4. Blood biomarkers [1 year]

    Lipid profile

  5. Blood biomarkers [1 year]

    Vitamin D levels

  6. Surveys [At the end of the study at 1 year]

    Semi structure interviews will be conducted and analysed via reflexive thematic approach.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandra Hospital Singapore Singapore 159964

Sponsors and Collaborators

  • Alexandra Hospital
  • National University Hospital, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandra Hospital
ClinicalTrials.gov Identifier:
NCT05967000
Other Study ID Numbers:
  • 2022/00350
  • NUS/BISI/SG02/2022
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexandra Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023