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

Part of paid clinical trials in San Francisco, California.

Sponsor
Northern California Institute of Research and Education
Study ID
NCT03401489
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 14, 2020
Status verified
Nov 2025
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PACESETTER
    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.
  • No Intervention: Healthy Lifestyle Intervention Group
    General lifestyle SMS matched in frequency and length to the intervention; monthly follow-ups; no devices, adherence monitoring, or physician-directed feedback.

Primary Outcome Measure

Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months [ Time Frame: 12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
NCIRESan FranciscoCalifornia94121-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of South CarolinaColumbiaSouth Carolina29203-
Regional Medical Center: Orangeburg HospitalOrangeburgSouth Carolina29118-

Find similar trials in San Francisco, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
NCIRE· San Francisco, CAMedical University of South Carolina· Charleston, SCUniversity of South Carolina· Columbia, SCRegional Medical Center: Orangeburg Hospital· Orangeburg, SC

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