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

Northern California Institute of Research and Education (NCIRE)

Status: Terminated

Conditions: Mhealth; Hypertension; Blood Pressure

Treatments: Device: PACESETTER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03401489

5R01MD012441-05 (U.S. NIH Grant/Contract)

Pro00070627

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

PACESETTER

Experimental group

Description:

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.

Treatment:

Device: PACESETTER

Healthy Lifestyle Intervention Group

No Intervention group

Description:

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