An interventional study of PACESETTER in Blood Pressure, Hypertension and Mhealth, sponsored by Northern California Institute of Research and Education. Terminated at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Northern California Institute of Research and Education · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Any condition that would limit participation in follow up assessments including severe cognitive impairment/dementia
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.
Device: PACESETTER
General lifestyle SMS matched in frequency and length to the intervention; monthly follow-ups; no devices, adherence monitoring, or physician-directed feedback.
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.
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
Stroke survivors with uncontrolled systolic hypertension were recruited from two safety-net health systems in South Carolina (MUSC and USC) between July 2020-February 2024. Potential participants were identified through EMR review and clinic screening. Recruitment ended at 60% of target due to COVID-19 disruptions and loss of funding. A total of 120 patients were enrolled and randomized 1:1.
| Milestone | PACESETTER | Healthy Lifestyle Intervention Group |
|---|---|---|
| Started | 60 | 60 |
| Completed | 26 | 21 |
| Not completed | 34 | 39 |
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.
| Participants | PACESETTER | Healthy Lifestyle Intervention Group |
|---|---|---|
| Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months | 15 | 17 |
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.
| mmHg | PACESETTER | Healthy Lifestyle Intervention Group |
|---|---|---|
| Mean Systolic Blood Pressure at 12 Months | 132.5 ± 20.8 | 134.9 ± 18.5 |
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.
| mmHg | PACESETTER | Healthy Lifestyle Intervention Group |
|---|---|---|
| Mean Diastolic Blood Pressure at 12 Months | 85.7 ± 12.8 | 88 ± 12.1 |
Collected over From randomization/enrollment until end of study follow-up at 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PACESETTER | 0/60 (0%) | 0/60 (0%) | 28/60 (46.7%) |
| Healthy Lifestyle Intervention Group | 0/60 (0%) | 0/60 (0%) | 21/60 (35%) |
| Event | PACESETTER | Healthy Lifestyle Intervention Group |
|---|---|---|
| Frequent urination (nocturia)Renal and urinary disorders | 12/60 | 10/60 |
| Fatigue/weaknessGeneral disorders | 9/60 | 6/60 |
| Constipation/diarrhea or stool changesGastrointestinal disorders | 7/60 | 5/60 |
| Age, Continuous(years) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Mean | 61.1 ± 10.2 | 59.7 ± 10.9 | 60.4 ± 10.6 |
| Sex: Female, Male(Participants) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Female | 25 | 27 | 52 |
| Male | 35 | 33 | 68 |
| Race (NIH/OMB)(Participants) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 39 | 38 | 77 |
| White | 21 | 22 | 43 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| United States | 60 | 60 | 120 |
| Modified Rankin Score (mRS)(units on a scale) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Mean | 1.8 ± .09 | 1.9 ± .08 | 1.85 ± 0.85 |
| Baseline DBP (mmHg)(mmHg) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Mean | 85.7 ± 12.8 | 88 ± 10.1 | 86.9 ± 11.5 |
| Number of Daily Medications ≥ 5(Participants) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Count of participants | 43 | 39 | 82 |
| Insurance Status(Participants) | PACESETTER | Healthy Lifestyle Intervention Group | Total |
|---|---|---|---|
| Private | 24 | 24 | 48 |
| Medicare/Medicaid | 23 | 17 | 40 |
| Both | 9 | 11 | 20 |
| No insurance | 4 | 8 | 12 |
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Northern California Institute of Research and Education