Blood Pressure, Hypertension, Mhealth
Conditions
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 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.
Interventions
DEVICEPACESETTER
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.
Sponsors
University of South Carolina
Medical University of South Carolina
National Institute on Minority Health and Health Disparities (NIMHD)
Northern California Institute of Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure at 12 Months | 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. |
| Mean Diastolic Blood Pressure at 12 Months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We assessed 200 individuals for eligibility; 80 did not meet inclusion criteria and declined participation, leaving 120 ischemic stroke patients with uncontrolled systolic hypertension who were randomized (60 intervention, 60 usual care). Randomization was stratified by race and site using permuted blocks within REDCap. All participants provided written informed consent prior to assignment
Participants by arm
| Arm | Count |
|---|---|
| PACESETTER Participants received a multicomponent mHealth-enabled self-management program. The intervention included a Bluetooth-enabled UA-767Plus BT home blood pressure monitor, an electronic medication pill tray (Vaica), and the PACESETTER smartphone app. The app provided instructional videos, automated relay of BP and adherence data to a secure server, and tailored SMS reminders and motivational messages. Biweekly adherence and BP summary reports were sent to study physicians to guide medication adjustments. | 60 |
| Healthy Lifestyle Intervention Group Participants continued standard post-stroke hypertension care. To balance contact frequency, they received general lifestyle SMS messages (not related to BP or medication adherence) matched in frequency and length to the intervention arm. Monthly phone calls from study staff confirmed follow-up and health encounters. No electronic devices, adherence monitoring, or physician-directed feedback were provided. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | PACESETTER | Total | Healthy Lifestyle Intervention Group |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 10.2 | 60.4 years STANDARD_DEVIATION 10.6 | 59.7 years STANDARD_DEVIATION 10.9 |
| Baseline DBP (mmHg) | 85.7 mmHg STANDARD_DEVIATION 12.8 | 86.9 mmHg STANDARD_DEVIATION 11.5 | 88 mmHg STANDARD_DEVIATION 10.1 |
| Insurance Status Both | 9 Participants | 20 Participants | 11 Participants |
| Insurance Status Medicare/Medicaid | 23 Participants | 40 Participants | 17 Participants |
| Insurance Status No insurance | 4 Participants | 12 Participants | 8 Participants |
| Insurance Status Private | 24 Participants | 48 Participants | 24 Participants |
| Modified Rankin Score (mRS) | 1.8 units on a scale STANDARD_DEVIATION 0.09 | 1.85 units on a scale STANDARD_DEVIATION 0.85 | 1.9 units on a scale STANDARD_DEVIATION 0.08 |
| Number of Daily Medications ≥ 5 | 43 Participants | 82 Participants | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 77 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 43 Participants | 22 Participants |
| Region of Enrollment United States | 60 Participants | 120 Participants | 60 Participants |
| Sex: Female, Male Female | 25 Participants | 52 Participants | 27 Participants |
| Sex: Female, Male Male | 35 Participants | 68 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 28 / 60 | 21 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
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
Population: Participants dropped out and in addition, the study was ended prematurely.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PACESETTER | Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months | 15 Participants |
| Healthy Lifestyle Intervention Group | Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months | 17 Participants |
Comparison: Comparison between PACESETTER and control arms at 12 months for proportion of participants with SBP \<130 mmHg using a generalized linear mixed model (GLMM) with logit link. Model included baseline SBP, site, and race as covariates.p-value: 0.82295% CI: [0.36, 2.72]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACESETTER | Mean Diastolic Blood Pressure at 12 Months | 85.7 mmHg | Standard Deviation 12.8 |
| Healthy Lifestyle Intervention Group | Mean Diastolic Blood Pressure at 12 Months | 88 mmHg | Standard Deviation 12.1 |
Comparison: Longitudinal mixed-effects repeated-measures modeling (MMRM) was used to compare diastolic BP over time, adjusting for baseline BP, site, and race.p-value: 0.61495% CI: [-7.8, 6]Mixed Models Analysis
Secondary
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
Population: Includes participants with at least one follow-up BP assessment (PACESETTER n=32; Control n=40). Missing values were handled using mixed-effects repeated-measures modeling under the missing-at-random assumption.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PACESETTER | Mean Systolic Blood Pressure at 12 Months | 132.5 mmHg | Standard Deviation 20.8 |
| Healthy Lifestyle Intervention Group | Mean Systolic Blood Pressure at 12 Months | 134.9 mmHg | Standard Deviation 18.5 |
p-value: 0.62395% CI: [-7.3, 12.1]Mixed Models Analysis