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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401489
Other study ID # Pro00070627
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 14, 2020
Est. completion date February 28, 2024

Study information

Verified date March 2024
Source Northern California Institute of Research and Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
PACESETTER
Patients will be given a Viaca 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.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States University of South Carolina Columbia South Carolina
United States Regional Medical Center: Orangeburg Hospital Orangeburg South Carolina
United States NCIRE San Francisco California

Sponsors (4)

Lead Sponsor Collaborator
Northern California Institute of Research and Education Medical University of South Carolina, Regional Medical Center: Orangeburg Hospital, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic BP Systolic blood pressure 12 months
Secondary Longitudinal Comparisons of BP comparison between intervention and control group 12 montjhs
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