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Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk
Parneet Grewal1, Ashley M Wabnitz1, Jenifer H Voeks1
1Department of Neurology Medical University of South Carolina Charleston SC USA.
Insights
The PACESETTER trial investigated a digital health intervention for blood pressure control in stroke survivors. Early termination due to low recruitment left its 12-month effectiveness uncertain.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Digital Health
Background:
- Stroke survivors in the southeastern US face poorer outcomes.
- Effective blood pressure (BP) reduction is crucial for stroke recovery.
- Less than one-third of stroke survivors achieve BP control within a year.
Purpose of the Study:
- To evaluate the PACESETTER intervention's impact on BP control in stroke survivors.
- To assess the efficacy of a digital health tool in managing hypertension post-stroke.
Main Methods:
- The PACESETTER trial randomized 120 stroke patients with uncontrolled BP.
- Intervention group used a Bluetooth pill tray, BP monitor, and smartphone app.
- Control group received usual care; primary outcome was systolic BP <130 mmHg at 12 months.
Main Results:
- The trial was halted early due to low recruitment and funding issues.
- At 4 months, the PACESETTER arm showed a trend toward better BP control (48.8% vs 29.3%, P=0.07).
- No significant difference in BP control was observed at 12 months (50% vs 47.2%, P=0.82).
Conclusions:
- Premature termination limits definitive conclusions on the PACESETTER intervention's 12-month efficacy.
- Further adequately powered trials are necessary to confirm the intervention's benefits.
- The study highlights the need for robust trials evaluating digital health for post-stroke BP management.
Background:
Individuals residing in the southeastern United States experience disproportionately worse stroke outcomes. Although blood pressure (BP) reduction is among the most effective strategies for improving stroke outcomes, fewer than one third of survivors of stroke achieve BP control within 1 year of the index event.
Methods:
The PACESETTER (Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor) trial enrolled patients with stroke and uncontrolled BP from 3 safety-net health care systems in South Carolina. Patients were randomized 1:1 to the PACESETTER intervention, which included a Bluetooth-enabled electronic pill tray, a BP monitor, and a smartphone application for automated data transmission of medication adherence and BP data to a central server or to usual care. The primary outcome was systolic BP <130 mm Hg at 12 months, analyzed according to the intention-to-treat principle.
Results:
The trial was stopped early due to low recruitment during the COVID-19 and funding constraints. Between September 2019 and February 2023, 120 participants were randomized to PACESETTER (n=60) or the usual care arm (n=60). At 4 months, systolic BP <130 mm Hg favored the PACESETTER arm (48.8% versus 29.3%, P=0.07), but no significant difference was observed at 12 months (50% versus 47.2%, P=0.82).
Conclusions:
Because the trial was terminated prematurely, the effect of the PACESETTER intervention on 12-month BP control after stroke remains uncertain. A trial completed to its full term and sufficiently powered to also evaluate key short-term end points is needed.
Registration:
URL: https://www.clinicalstrial.org; Unique Identifier: NCT03401489.
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