Towards an integrated blood pressure self-monitoring solution for stroke/TIA in Ireland: a mixed methods feasibility study for the TASMIN5S IRL randomised controlled trial

R Doogue; P Hayes; R Hebert; A Sheikhi; T Rai; K Morton; C Roman; R J McManus; L G Glynn

doi:10.1186/s40814-023-01240-2

Towards an integrated blood pressure self-monitoring solution for stroke/TIA in Ireland: a mixed methods feasibility study for the TASMIN5S IRL randomised controlled trial

Pilot Feasibility Stud. 2023 Jan 13;9(1):9. doi: 10.1186/s40814-023-01240-2.

Authors

R Doogue¹, P Hayes^{2

3}, R Hebert², A Sheikhi³, T Rai⁴, K Morton⁵, C Roman⁶, R J McManus⁴, L G Glynn^{2

7}

Affiliations

¹ School of Medicine, University of Limerick, Limerick, Ireland. roisin.doogue@ul.ie.
² School of Medicine, University of Limerick, Limerick, Ireland.
³ Health Research Institute, University of Limerick, Limerick, Ireland.
⁴ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁵ Centre for Clinical and Community Applications of Health Psychology, School of Psychology, University of Southampton, Southampton, SO17 1BJ, UK.
⁶ Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.
⁷ HRB Primary Care Clinical Trial Network Ireland, Galway, Ireland.

Abstract

Background: Optimising blood pressure (BP) control is one of the most important modifiable risk factors in preventing subsequent stroke where the risk increases by one-third for every 10 mmHg rise in systolic BP. This study evaluated the feasibility and potential effectiveness of blood pressure self-monitoring with planned medication titration, to inform a definitive trial of the intervention, in patients with a previous stroke or transient ischaemic attack (TIA).

Methods: Patients with a history of stroke/TIA and sub-optimal BP control were invited to take part in a mixed methods feasibility study for a randomised controlled trial. Those meeting the inclusion criteria with systolic BP >130 mmHg were randomised to a self-monitoring intervention group or usual care group. The intervention involved self-monitoring BP twice a day for 3 days within a 7-day period, every month, following text message reminders. Treatment escalation, based on a pre-agreed plan by the general practitioner (GP) and patient, was initiated according to the results of these readings. Semi-structured interviews were carried out with patients and clinicians and analysed thematically.

Results: Of those identified, 47% (32/68) attended for assessment. Of those assessed, 15 were eligible for recruitment and were consented and randomised to the intervention or control group on a 2:1 basis. Of those randomised, 93% (14/15) completed the study and there were no adverse events. Systolic BP was lower in the intervention group at 3 months. Participants found the intervention acceptable and easy to use. GPs found it easy to incorporate into their practice activity without increasing workload.

Conclusions: TASMIN5S, an integrated blood pressure self-monitoring intervention in patients with a previous stroke/TIA, is feasible and safe to deliver in primary care. A pre-agreed three-step medication titration plan was easily implemented, increased patient involvement in their care, and had no adverse effects. This feasibility study provides important information to inform a definitive trial to determine the potential effectiveness of the intervention in patients post-stroke or TIA.

Trial registration: ISRCTN57946500 . Registered on 12/08/2019.

Keywords: Blood pressure; Feasibility studies; Qualitative research; Randomised controlled trial; Self-monitoring; Stroke.

Abstract

Grants and funding