Clinical trial NCT03401489: PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
Official title: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Mhealth
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: Medical University of South Carolina
name: Regional Medical Center: Orangeburg Hospital
First posted: 2018-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic BP
timeFrame: 12 months
Secondary outcomes:
measure: Longitudinal Comparisons of BP
timeFrame: 12 montjhs
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: NCIRE
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Orangeburg
country: United States
facility: Regional Medical Center: Orangeburg Hospital
state: South Carolina
Study officials:
References:
citation: 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.