NCT03401489

PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor

Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Northern California Institute of Research and Education · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor (PACESETTER) aims to assess the incorporation of its stroke intervention into 2 safety net/academic health systems in a given US state especially burdened by stroke, thereby enhancing knowledge about the complexity of stroke interventions, and especially the nature of the challenges encountered in low resource settings and for populations traditionally underrepresented in research. Altogether, the intervention, if proven implementable and effective, may eventually be exported to other medically underserved populations in the US beyond SC as a feasible model of post-stroke management.

Conditions

• Blood Pressure
• Hypertension
• Mhealth

Interventions

Type	Name	Description
DEVICE	PACESETTER	Patients will be given a Vaica electronic pill tray \& blue-toothed UA-767 Plus BT BP device and the PACESETTER app installed on their smart phone for automatic relay of BP data. The Vaica tray emits a blinking light for 30 minutes when it is time to take the meds. If the compartment is not opened and emptied, an intermittent chime ensues for 30 minutes. If the compartment is not opened and emptied, the subject /caregiver receives an automated SMS. PACESETTERs will be given a questionnaire. Responses will be used to generate personalized motivational \& reinforcement messages guided by self-determination theory constructs of competence \& autonomous regulation. In addition to personalized messages, PACESETTERs will receive text messages 2 times per week on HTN/stroke facts, importance of med adherence, and tips on expressing questions/concerns with a physician. We will calculate medication possession ratios, on all subjects' HTN medications at each evaluation.

Timeline

• Start date: 2020-07-14
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2018-01-17
• Last updated: 2025-12-11
• Results posted: 2025-11-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study