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

NCT03401489 | Terminated Results DMC FDA Device

• 2 other identifiers: Pro000706275R01MD012441-05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Mean Systolic Blood Pressure at 12 Months

  12 months

• Mean Diastolic Blood Pressure at 12 Months

  12 months

Study Arms (2)

PACESETTER

EXPERIMENTAL

Participants in the PACESETTER arm received a multicomponent, mHealth-enabled self-management program designed to improve post-stroke blood-pressure control. Each participant was provided a Bluetooth-enabled UA-767Plus BT home blood-pressure monitor, a Vaica electronic medication tray that emitted visual and auditory reminders, and the PACESETTER smartphone app. The app delivered instructional videos, enabled automatic transmission of BP and adherence data to a secure server, and generated tailored SMS messages based on self-determination-theory constructs of competence and autonomous regulation. Participants also received twice-weekly educational text messages regarding hypertension and stroke prevention, medication adherence, and communication with clinicians. Bi-weekly adherence and BP summaries were sent to study physicians to guide medication adjustments. Study coordinators contacted participants monthly to ensure device functioning and collect follow-up data.

Device: PACESETTER

Healthy Lifestyle Intervention Group

NO INTERVENTION

General lifestyle SMS matched in frequency and length to the intervention; monthly follow-ups; no devices, adherence monitoring, or physician-directed feedback.

Interventions

PACESETTER DEVICE

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.

PACESETTER

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead
• University of South Carolina: collaborator
• Medical University of South Carolina: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

NCIRE

San Francisco, California, 94121, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29203, United States

Location

Regional Medical Center: Orangeburg Hospital

Orangeburg, South Carolina, 29118, United States

Location

Related Publications (1)

• Wabnitz AM, Chandler J, Treiber F, Sen S, Jenkins C, Newman JC, Mueller M, Tinker A, Flynn A, Tagge R, Ovbiagele B. Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk factor: Protocol of a RCT. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105815. doi: 10.1016/j.jstrokecerebrovasdis.2021.105815. Epub 2021 May 27.

  PMID: 34052785 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study did not reach the planned sample size due to COVID-19 disruptions and funding loss, resulting in high attrition and limited power. Lack of a multidisciplinary telehealth component and community-based retention strategies may have reduced engagement. Investigators and participants were unblinded, though blinded evaluators assessed outcomes. Findings may be less generalizable beyond safety-net hospitals in the Southeastern U.S. Findings will be submitted for peer-review publication.

Results Point of Contact

• Title: Bruce Ovbiagele
• Organization: San Francisco VA Medical Center

bruce.ovbiagele@va.gov

415-750-2047

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: July 14, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: December 11, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)