PHYLLIS

  • Research type

    Research Study

  • Full title

    Prevent from Home: Young person and buddies’ cardiovascuLar heaLth Improvement feasibility Study (PHYLLIS)

  • IRAS ID

    1008673

  • Contact name

    Kate Bramham

  • Contact email

    kate.bramham@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • ISRCTN Number

    ISRCTN17524311

  • Research summary

    Heart attacks and strokes cause the greatest number of preventable deaths in the UK. People from ethnic minority
    groups and those with socioeconomic deprivation are most severely affected. Women who develop high blood
    pressure or diabetes during pregnancy are up to ten times more likely to develop these problems in later life. New
    medications (Sodium glucose transport protein-2 inhibitors, SGLT2i) can prevent heart attacks, strokes and kidney
    disease, they also reduce weight, blood pressure, and blood sugar but we do not know if they can prevent high blood
    pressure and diabetes developing.

    Women find it very difficult to take part in research in the postnatal period, particularly those from ethnic minorities. We
    have spoken to patients with lived experience of pregnancies complicated by high blood pressure and diabetes, in
    addition to members of the public, and co-designed a study to ensure the design best supports postnatal
    participation. The study involves:
    - using ‘postpartum health champions’ to support women taking part in the study
    - home-testing and digital data entry
    - using of ‘study-buddies’ (a friend or family member with pre-diabetes or borderline high blood pressure) to support
    women taking part in the study, in addition to increasing awareness and reassurance about research.

    PHYLLIS is a feasibility study of a randomised controlled trial which will compare outcomes of 108 women (and their
    study-buddies) who take SGLT2i with women who do not, and explore different ways to support postnatal women
    taking part in maternity research.

  • REC name

    London - South East Research Ethics Committee

  • REC reference

    24/LO/0902

  • Date of REC Opinion

    16 Jan 2025

  • REC opinion

    Further Information Favourable Opinion