Key result
Although the trial was terminated early due to the COVID-19 pandemic, routinely recorded post-randomisation mean systolic blood pressure was 130 mmHg with self-monitoring versus 134 mmHg with usual care.
Why the study?
Blood pressure control following stroke is important but currently sub-optimal, prompting evaluation of whether self-monitoring with telemonitoring and treatment escalation lowers BP more than usual care.
Does a digital self-monitoring and telemonitoring intervention reduce blood pressure compared to usual care in patients with previous stroke or TIA?
RCT (n=55)
Open-label
1:1 using secure online system
Yes
Does a digital self-monitoring and telemonitoring intervention reduce blood pressure compared to usual care in patients with previous stroke or TIA?
Absolute Event Rate: 130% vs 134%
A digital blood pressure self-monitoring and telemonitoring intervention was highly feasible and acceptable for stroke/TIA patients, though early termination precluded definitive efficacy conclusions.
Telemonitoring with self-monitoring is feasible post-stroke/TIA; leaves open efficacy for BP lowering in definitive trials.
BACKGROUND: Blood pressure (BP) control following stroke is important but currently sub-optimal. This trial aimed to determine whether self-monitoring of hypertension with telemonitoring and a treatment escalation protocol, results in lower BP than usual care in people with previous stroke or transient ischaemic attack (TIA). METHODS: Unblinded randomised controlled trial, comparing a BP telemonitoring-based intervention with control (usual care) for hypertension management in 12 primary care practices in England. People with previous stroke or TIA with clinic systolic BP 130-180 mmHg, taking ≤ 3 antihypertensive medications and on stable treatment for at least four weeks were randomised 1:1 using secure online system to intervention or control. The BP:Together intervention comprised self-monitoring of blood pressure with a digital behavioural intervention which supported telemonitoring of self-monitored BP with feedback to clinicians and patients regarding medication titration. The planned primary outcome was difference in clinic measured systolic BP 12 months from randomisation but was not available following early study termination due to withdrawal of funding during the COVID-19 pandemic. Instead, in addition to pre-randomised data, routinely recorded BP was extracted from electronic patient records both pre- and post-randomisation and presented descriptively only. An intention to treat approach was taken. RESULTS: From 650 postal invitations, 129 (20%) responded, of whom 95 people had been screened for eligibility prior to the pandemic (November 2019-March 2020) and 55 (58%) were randomised. Pre-randomisation routinely recorded mean BP was 145/78 mmHg in the control (n = 26) and 145/79 mmHg in the self-monitoring (n = 21) groups. Post-randomisation mean BP was 134/73 mmHg in the control (n = 19) and 130/75 mmHg in the self-monitoring (n = 25) groups. Participants randomised to self-monitoring used the intervention for ≥ 7 months in 25/27 (93%) of cases. CONCLUSIONS: Recruitment of people with stroke/TIA to a trial comparing a BP self-monitoring and digital behavioural intervention to usual care was feasible prior to the COVID-19 pandemic and the vast majority of those randomised to intervention used it while the trial was running. Routinely recorded blood pressure control improved in both groups. Digital interventions including self-monitoring are feasible for people with stroke/TIA and should be definitively evaluated in future trials. TRIAL REGISTRATION: ISRCTN57946500 06/09/2019 Prospective.
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McManus et al. (2024) conducted an RCT in Hypertension with previous stroke or transient ischaemic attack (TIA) (n=55). BP:Together intervention (self-monitoring of blood pressure with telemonitoring) vs. Usual care was evaluated on Difference in clinic measured systolic blood pressure at 12 months (planned, but only descriptive routine data available due to early termination). Although the trial was terminated early due to the COVID-19 pandemic, routinely recorded post-randomisation mean systolic blood pressure was 130 mmHg with self-monitoring versus 134 mmHg with usual care.
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