Evaluating a Preventive Heart Health Programme for Women at Midlife

NCT05967000 | Unknown DMC

• 2 other identifiers: 2022/00350NUS/BISI/SG02/2022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Menopause

Keywords

preventive cardiology; menopause; implementation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Implementation of the programme

  This will be measured as counts from clinic visits

  1 year

Secondary Outcomes (6)

• Anthropometric measurements

  1 year

• Blood pressure

  1 year

• Blood biomarkers

  1 year

• Blood biomarkers

  1 year

• Blood biomarkers

  1 year

Study Arms (1)

Women at midlife

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

Other: Preventive heart health and menopause programme

Interventions

Preventive heart health and menopause programme OTHER

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.

Women at midlife

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women going through the menopause transition with risk factors for CVD or pre-existing CVD.

You may qualify if:

• Women aged 45-65 years at risk for cardiovascular disease or with pre-existing cardiovascular disease.
• English speaking

You may not qualify if:

• Pregnant women
• Unable to provide informed consent
• Women out of the menopause transition phase of 45-65 years of age.

Sponsors & Collaborators

• Alexandra Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Alexandra Hospital

Singapore, 159964, Singapore

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 1, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)