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

Primary Purpose

Blood Pressure, Hypertension, Mhealth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACESETTER
Sponsored by
Northern California Institute of Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NCIRE
  • Medical University of South CarolinaRecruiting
  • University of South CarolinaRecruiting
  • Regional Medical Center: Orangeburg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PACESETTER

Healthy Lifestyle Intervention Group

Arm Description

Outcomes

Primary Outcome Measures

Systolic BP
Systolic blood pressure

Secondary Outcome Measures

Longitudinal Comparisons of BP
comparison between intervention and control group

Full Information

First Posted
January 10, 2018
Last Updated
July 5, 2023
Sponsor
Northern California Institute of Research and Education
Collaborators
University of South Carolina, Medical University of South Carolina, Regional Medical Center: Orangeburg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03401489
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern California Institute of Research and Education
Collaborators
University of South Carolina, Medical University of South Carolina, Regional Medical Center: Orangeburg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypertension, Mhealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PACESETTER
Arm Type
Experimental
Arm Title
Healthy Lifestyle Intervention Group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
PACESETTER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic BP
Description
Systolic blood pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Longitudinal Comparisons of BP
Description
comparison between intervention and control group
Time Frame
12 montjhs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruce Ovbiagele, MD
Phone
415-221-4810
Ext
25327
Email
bruce.ovbiagele@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Raelle Tagge, MPH
Email
raelle.tagge@ncire.org
Facility Information:
Facility Name
NCIRE
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raelle Tagge, MPH
Email
raelle.tagge@ncire.org
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenreka Yeadon
Email
yeadon@musc.edu
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makenzie Logue
Email
makenzie.logue@prismahealth.org
Facility Name
Regional Medical Center: Orangeburg Hospital
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tushar Trivedi, MD
Email
ttrivedi@regmed.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34052785
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.
Results Reference
derived

Learn more about this trial

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

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