PAM trial

  • Research type

    Research Study

  • Full title

    Programme on Adherence to Medication (PAM): A very brief face to face intervention, followed by a text message and/or app intervention to support medication adherence in people prescribed treatment for hypertension in primary care. A randomised controlled trial

  • IRAS ID

    268471

  • Contact name

    Stephen Sutton

  • Contact email

    srs34@medschl.cam.ac.uk

  • Sponsor organisation

    University of Cambridge

  • ISRCTN Number

    ISRCTN82013652

  • Duration of Study in the UK

    2 years, 6 months, 29 days

  • Research summary

    Background. This research project aims to evaluate the effectiveness and cost effectiveness of PAM, a very brief face-to-face consultation (VBI) followed by a text message or app intervention aiming to support adherence to patients prescribed antihypertensive medications in primary care. It will also aim to assess uptake and attrition rates, implementation procedures, including fidelity and mechanism of action. PAM intervention has been developed based on theory and evidence, PPI/E and stakeholders' consultations. The implementations procedures were refined during our pilot study (with n=24 patients) and feasibility randomised controlled trial (with n=100 patients).

    Methods. The PAM trial is an individually randomised two arm trial in adults treated for hypertension in primary care. The intervention is delivered using VBI by practice nurses or health care assistants, followed by a three-month highly tailored and interactive text messaging or smartphone app intervention. Comparator group is usual care. Participants are 1:1 individually randomised to usual care (n=382) or PAM intervention (n=382) stratified by practitioner only. The primary outcome is change in systolic blood pressure at 12-months follow up from baseline measured by practice staff blinded to group allocation. Secondary outcome include medication adherence measured by urine analysis and self-reports, quality of life, and satisfaction with treatment and care.

    Discussion. The PAM intervention uses a VBI to enroll patients in a three months text or app intervention to support treatment adherence to hypertension. The intervention has been proved to be feasible to support adherence and this study will test its effectiveness and cost effectiveness.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    19/EE/0354

  • Date of REC Opinion

    5 Feb 2020

  • REC opinion

    Further Information Favourable Opinion