Self-monitoring of blood pressure following a stroke or transient ischaemic attack (TASMIN5S): a randomised controlled trial cut short by covid-19.

Conference:

SAPC ASM 2022 - UCLan

Talk Code:

4D.7

Presenter:

Richard McManus

Twitter:

@RichardJMcManus

Co-authors:

A Smith, E Temple, J Allen, R Doogue, G Ford, L Glynn, B Guthrie, P Hall, L Hinton, R Hobbs, J Mant, B McKinstry, S Mort, T Rai, C Rice, C Roman, A Stoddart, L Tarassenko, J Thomson, C Velardo, L Yardley, LM Yu

Author institutions:

Universities of Oxford, Limerick, Edinburgh, Cambridge and Bristol.

Problem

Raised blood pressure after stroke is a significant risk factor for secondary stroke and other cardiovascular events. Digital interventions can support people to monitor their own blood pressure at home, share readings with the healthcare team, and facilitate appropriate medication change. However, it is not known how best to optimise self-management digital interventions for stroke or transient ischaemic attack (TIA) patients, who may experience a range of communication and physical impairments.

Approach

An integrated approach was adopted to develop an optimal digital intervention to support stroke/TIA patients to manage their high blood pressure in Primary Care. This drew on evidence, theory and the Person-Based Approach. The intervention was tested in an unmasked randomised controlled trial comparing a self-monitoring of blood pressure intervention versus usual care for the management of hypertension following stroke or TIA. People with a history of previous stroke or TIA from 12 general practices in the UK were randomised (1:1) intervention to control. Patients in the intervention group recorded self-monitored blood pressure via an app developed specifically for use by people with stroke. The primary outcome was the difference in clinic measured systolic blood pressure at 12 months from randomisation but was not available due to early termination of the study following suspension in the first lockdown. Instead, as well as baseline pre-randomised data, routinely recorded systolic and diastolic blood pressure were extracted from electronic patient records for the time period 1/11/2018-1/12/2020 aiming to capture both pre- and post-randomisation data. Trial registration ICTRN 57946500.

Findings

The trial was stopped early by the funders due to the COVID-19 pandemic despite study redesign for remote delivery. Of 95 people screened for eligibility, 55 were randomised. Mean baseline trial blood pressure was 146/82 mmHg (self-monitoring, n=27) and 146/80 mmHg (control, n=28). Pre- and post-randomisation routinely recorded blood pressures were available from 39 participants: 143/78 mmHg (pre) and 131/75 mmHg (post)(n=20, self-monitoring) and 145/79 mmHg and 134/73 mmHg (n=19, usual care) respectively.

Consequences

A complex digital health intervention was created for stroke and TIA patients. Recruitment of people with stroke/TIA to a trial comparing this digital intervention to usual care was possible prior to the pandemic. Routinely recorded blood pressure dropped in both groups. Digital interventions including self-monitoring of blood pressure are feasible for people with stroke or TIA and should be further evaluated in future trials.

Submitted by:

Richard McManus

Funding acknowledgement:

This work was funded by the Stroke Association and British Heart Foundation. Analysis and writing up funded by NIHR Oxford and Thames Valley Applied Research Collaborative.