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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401489
• Other study ID #: Pro00070627
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Mhealth

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