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

Study Overview
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Brief Summary
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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 sytems 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.

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

Conditions
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Mhealth, Blood Pressure, Hypertension

Intervention / Treatment
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* Device: PACESETTER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American or non-Hispanic white history of stroke (within six months of symptom onset) uncontrolled HTN (SBP ≥ 130 mmHg at the last clinical encounter post-stroke prior to recruitment) owning a smartphone with a data plan able to take their own BP and self-administer medications. Exclusion Criteria: Any condition that would limit participation in follow up assessments including severe cognitive impairment/dementia severe global disability (modified Rankin Score ≥ 3) BMI> 40kg/m^2 Not being able to speak, hear, or understand English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACESETTER<br> | Device: PACESETTER<br>* Patients will be given a Viaca 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.<br>|
| No Intervention: Healthy Lifestyle Intervention Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic BP | Systolic blood pressure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Comparisons of BP | comparison between intervention and control group | 12 montjhs |