Blood PressureNCT03401489
PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
A study testing PACESETTER in people with Blood Pressure and Hypertension, run by Northern California Institute of Research and Education at 4 sites in United States.
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 systems in a given US state especially burdened by stroke, thereby enhancing knowledge about… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure, Hypertension, Mhealth
- What is being tested?
- PACESETTER
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jul 2020to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of South Carolina
Columbia, South Carolina, 29203
Regional Medical Center: Orangeburg Hospital
Orangeburg, South Carolina, 29118
NCIRE
San Francisco, California, 94121
About this study
Official title: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
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 systems 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.
- Conditions
- Blood Pressure, Hypertension, Mhealth
- Being tested
- PACESETTER
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACESETTERDevice
Patients will be given a Vaica 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.
| Study group | Role | What they receive |
|---|---|---|
| PACESETTER | Experimental | Participants in the PACESETTER arm received a multicomponent, mHealth-enabled self-management program designed to improve post-stroke blood-pressure control. Each participant was provided a Bluetooth-enabled UA-767Plus BT home blood-pressure monitor, a Vaica electronic medication tray that emitted visual and auditory reminders, and the PACESETTER smartphone app.
The app delivered instructional videos, enabled automatic transmission of BP and adherence data to a secure server, and generated tailored SMS messages based on self-determination-theory constructs of competence and autonomous regulation. Participants also received twice-weekly educational text messages regarding hypertension and stroke prevention, medication adherence, and communication with clinicians.
Bi-weekly adherence and BP summaries were sent to study physicians to guide medication adjustments. Study coordinators contacted participants monthly to ensure device functioning and collect follow-up data. Receives: Device: PACESETTER |
| Healthy Lifestyle Intervention Group | No intervention | General lifestyle SMS matched in frequency and length to the intervention; monthly follow-ups; no devices, adherence monitoring, or physician-directed feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months
Clinic systolic blood pressure (SBP) was measured at 12 months after randomization. The proportion of participants in each arm achieving SBP <130 mmHg was calculated.
Measured: 12 months
Secondary outcomes (2)
Mean Systolic Blood Pressure at 12 Months
Clinic systolic blood pressure (SBP, mmHg) measured at baseline, 4, 8, and 12 months after randomization. The 12-month value is reported here, comparing intervention and control arms. Lower values indicate better blood-pressure control.
Measured: 12 months
Mean Diastolic Blood Pressure at 12 Months
Clinic diastolic blood pressure (DBP, mmHg) measured at the 12-month value is reported here, comparing intervention and control arms. Lower values indicate better blood-pressure control.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start14 Jul 2020
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: Study delays and ran out of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Bruce Ovbiagele, Northern California Institute of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401489
- Sponsor's protocol ID
- Pro00070627
- Other IDs
- 5R01MD012441-05
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2018
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Grewal P, Wabnitz AM, Voeks JH, Sen S, Trivedi T, Joseph C, Yeadon KT, Tagge R, Ovbiagele B. Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor: A Randomized Trial. J Am Heart Assoc. 2026 Aug 20:e048147. doi: 10.1161/JAHA.125.048147. Online ahead of print.
PubMed 42622217Wabnitz 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.
PubMed 34052785
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
- ClinicalTrials.gov ID
- NCT03401489
- Acronym / sponsor ID
- Pro00070627
- Conditions
- Blood Pressure, Hypertension, Mhealth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study delays and ran out of funding
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 systems 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACESETTER | Experimental | Device: PACESETTERParticipants in the PACESETTER arm received a multicomponent, mHealth-enabled self-management program designed to improve post-stroke blood-pressure control. Each participant was provided a Bluetooth-enabled UA-767Plus BT home blood-pressure monitor, a Vaica electronic medication tray that emitted visual and auditory reminders, and the PACESETTER smartphone app. The app delivered instructional videos, enabled automatic transmission of BP and adherence data to a secure server, and generated tailored SMS messages based on self-determination-theory constructs of competence and autonomous regulation. Participants also received twice-weekly educational text messages regarding hypertension and stroke prevention, medication adherence, and communication with clinicians. Bi-weekly adherence and BP summaries were sent to study physicians to guide medication adjustments. Study coordinators contacted participants monthly to ensure device functioning and collect follow-up data. |
| Healthy Lifestyle Intervention Group | No intervention | –General lifestyle SMS matched in frequency and length to the intervention; monthly follow-ups; no devices, adherence monitoring, or physician-directed feedback. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Any condition that would limit participation in follow up assessments including severe cognitive impairment/dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACESETTERPatients will be given a Vaica 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. | Device | PACESETTER |
Primary outcome
Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months
Time frame: 12 months
Clinic systolic blood pressure (SBP) was measured at 12 months after randomization. The proportion of participants in each arm achieving SBP <130 mmHg was calculated.
2 secondary outcomes
Mean Systolic Blood Pressure at 12 Months
Time frame: 12 months
Mean Diastolic Blood Pressure at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42622217Grewal P, Wabnitz AM, Voeks JH, Sen S, Trivedi T, Joseph C, Yeadon KT, Tagge R, Ovbiagele B. Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor: A Randomized Trial. J Am Heart Assoc. 2026 Aug 20:e048147. doi: 10.1161/JAHA.125.048147. Online ahead of print.
- Derived from this study: PubMed 34052785Wabnitz 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.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACESETTER in people with Blood Pressure and Hypertension, run by Northern California Institute of Research and Education at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.