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

Not Applicable

Completed

• Conditions: Mhealth; Hypertension; Blood Pressure
• Interventions: Device: PACESETTER

• Registration Number: NCT03401489
• Lead Sponsor: Northern California Institute of Research and Education

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-17
• Study Start: 2020-07-14
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PACESETTER	PACESETTER	-

Primary Outcome Measures

Name	Time	Method
Systolic BP	12 months	Systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Longitudinal Comparisons of BP	12 montjhs	comparison between intervention and control group

Trial Locations

Locations (4)

NCIRE; 🇺🇸 San Francisco, California, United States

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Regional Medical Center: Orangeburg Hospital; 🇺🇸 Orangeburg, South Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States