xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05967000</url>
    </required_header>
    <id_info>
      <org_study_id>2022/00350</org_study_id>
      <secondary_id>NUS/BISI/SG02/2022</secondary_id>
      <nct_id>NCT05967000</nct_id>
    </id_info>
    <brief_title>Evaluating a Preventive Heart Health Programme for Women at Midlife</brief_title>
    <acronym>Phenomenon</acronym>
    <official_title>Evaluating a Preventive Heart Health Programme for Perimenopausal Women - Empowering Sustainable Healthy Habits Through Behaviour Change Strategy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandra Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National University Hospital, Singapore</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Alexandra Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study examines the factors that limit or support the implementation of a pilot heart&#xD;
        health program for perimenopausal women. The investigators evaluate the effectiveness of this&#xD;
        program in raising awareness and promoting behavior change to maintain cardiovascular health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease (CVD) is the leading cause of mortality among women. Heart-related&#xD;
        conditions are responsible for the death of one out of every three women. In Singapore, CVD&#xD;
        in women causes more morbidity and mortality than breast and cervical cancer. The burden will&#xD;
        be exacerbated by Singapore's aging population and the longer life expectancy of women&#xD;
        compared to men. Primary and secondary prevention strategies are implemented to reduce the&#xD;
        overall impact of CVD on public health. Women who have traditional risk factors are at a&#xD;
        greater risk of experiencing heart attacks compared to men with comparable risk factors.&#xD;
        Additional risks specific to women include a history of pregnancy complications, breast&#xD;
        cancer, and premature menopause. CVDs in women are frequently overlooked in terms of&#xD;
        diagnosis and treatment.&#xD;
  &#xD;
        Menopause is a phase in a woman's life that brings about significant changes to both her&#xD;
        reproductive organs and her physical and psychological well-being. Management issues&#xD;
        encompass a spectrum of concerns, including immediate symptoms like insomnia and&#xD;
        palpitations, intermediate concerns related to bone health, and long-term considerations&#xD;
        associated with the development of cardiovascular disease. The American Heart Association&#xD;
        (AHA) provides guidelines for multidisciplinary care aimed at preventing cardiovascular&#xD;
        disease (CVD) in women. Countries like Canada have established specialized organizations to&#xD;
        address this issue. Collaborative clinics involving cardiologists, gynecologists, and women's&#xD;
        heart centers are crucial, even for women who are generally healthy.&#xD;
  &#xD;
        The objective of this study is to examine the factors that limit or support the&#xD;
        implementation of a preventive heart health program for perimenopausal women. Additionally,&#xD;
        the investigators aim to evaluate the effectiveness of our pilot women's health program in&#xD;
        raising awareness and promoting behavior change to maintain cardiovascular health.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Reach of the programme</measure>
      <time_frame>1 year</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effectiveness of the programme</measure>
      <time_frame>1 year</time_frame>
      <description>This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effectiveness of the programme</measure>
      <time_frame>1 year</time_frame>
      <description>This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the Utian Quality of life scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoption of the programme</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Implementation of the programme</measure>
      <time_frame>1 year</time_frame>
      <description>This will be measured as counts from clinic visits</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anthropometric measurements</measure>
      <time_frame>1 year</time_frame>
      <description>Weight and height will be combined to report BMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>1 year</time_frame>
      <description>Office blood pressure measurements</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood biomarkers</measure>
      <time_frame>1 year</time_frame>
      <description>Hba1c</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood biomarkers</measure>
      <time_frame>1 year</time_frame>
      <description>Lipid profile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood biomarkers</measure>
      <time_frame>1 year</time_frame>
      <description>Vitamin D levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surveys</measure>
      <time_frame>At the end of the study at 1 year</time_frame>
      <description>Semi structure interviews will be conducted and analysed via reflexive thematic approach.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cardiovascular Disease</condition>
    <condition>Menopause</condition>
    <arm_group>
      <arm_group_label>Women at midlife</arm_group_label>
      <description>Women aged 45-65 years with risk factors or pre-existing CVD</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Preventive heart health and menopause programme</intervention_name>
      <description>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:&#xD;
  Individualised risk assessment, screening, diagnosis, and treatment of CVD.&#xD;
  Lifestyle education, adjustment, stress management, and counselling.&#xD;
  Smoking cessation programs.&#xD;
  Bone health screening, mammogram with access to our co-located gynaecologists and hormone replacement therapy.&#xD;
  Virtual consults and health coaching.</description>
      <arm_group_label>Women at midlife</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women going through the menopause transition with risk factors for CVD or pre-existing CVD.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 45-65 years at risk for cardiovascular disease or with pre-existing&#xD;
               cardiovascular disease.&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
  &#xD;
            -  Women out of the menopause transition phase of 45-65 years of age.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alexandra Hospital</name>
        <address>
          <city>Singapore</city>
          <zip>159964</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>preventive cardiology</keyword>
    <keyword>menopause</keyword>
    <keyword>implementation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05967000
  org study id: 2022/00350
  secondary id: NUS/BISI/SG02/2022
  nct id: NCT05967000
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Case-Only
  time perspective: Prospective
  measure: Reach of the programme
  time frame: 1 year
  description: 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
  measure: Effectiveness of the programme
  time frame: 1 year
  description: This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the GPAQ (Global physical activity questionnaire)
  measure: Effectiveness of the programme
  time frame: 1 year
  description: This a part of the RE-AIM comprehensive method for programme evaluation. This is measured via the Utian Quality of life scale.
  measure: Adoption of the programme
  time frame: 1 year
  description: 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.
  measure: Implementation of the programme
  time frame: 1 year
  description: This will be measured as counts from clinic visits
  measure: Anthropometric measurements
  time frame: 1 year
  description: Weight and height will be combined to report BMI in kg/m^2
  measure: Blood pressure
  time frame: 1 year
  description: Office blood pressure measurements
  measure: Blood biomarkers
  time frame: 1 year
  description: Hba1c
  measure: Blood biomarkers
  time frame: 1 year
  description: Lipid profile
  measure: Blood biomarkers
  time frame: 1 year
  description: Vitamin D levels
  measure: Surveys
  time frame: At the end of the study at 1 year
  description: Semi structure interviews will be conducted and analysed via reflexive thematic approach.
  arm group label: Women at midlife
  description: Women aged 45-65 years with risk factors or pre-existing CVD
  intervention type: Other
  intervention name: Preventive heart health and menopause programme
  description: 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.
  arm group label: Women at midlife
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 45 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  sharing ipd: No