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

Northern California Institute of Research and Education120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Blood Pressure Hypertension Mhealth

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

NCIRE

San Francisco, California, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of South Carolina

Columbia, South Carolina, United States

Regional Medical Center: Orangeburg Hospital

Orangeburg, South Carolina, United States

Outcomes

Primary Outcomes

Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months

Clinic systolic blood pressure (SBP) was measured at 12 months after randomization. The proportion of participants in each arm achieving SBP \<130 mmHg was calculated.

Time frame: 12 months

Secondary Outcomes

Mean Systolic Blood Pressure at 12 Months

Clinic systolic blood pressure (SBP, mmHg) measured at baseline, 4, 8, and 12 months after randomization. The 12-month value is reported here, comparing intervention and control arms. Lower values indicate better blood-pressure control.

Time frame: 12 months

Mean Diastolic Blood Pressure at 12 Months

Clinic diastolic blood pressure (DBP, mmHg) measured at the 12-month value is reported here, comparing intervention and control arms. Lower values indicate better blood-pressure control.

Time frame: 12 months