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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MD012441-05 | U.S. NIH Grant/Contract | View source |
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Study delays and ran out of funding
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| Name | Class |
|---|---|
| University of South Carolina | OTHER |
| Medical University of South Carolina | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACESETTER | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Mean Diastolic Blood Pressure at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Any condition that would limit participation in follow up assessments including severe cognitive impairment/dementia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCIRE | San Francisco | California | 94121 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34052785 | Derived | 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. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2021 |
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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. |
| 12 months |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Regional Medical Center: Orangeburg Hospital | Orangeburg | South Carolina | 29118 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, Continuous: Mean ± SD | Mean | Standard Deviation | years |
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| Sex: Female, Male | Male/Female | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | South Carolina, USA | Number | Participants |
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| Modified Rankin Score (mRS) | The Modified Rankin Scale (mRS) measures the degree of disability or dependence in daily activities after a stroke. The total score ranges from 0 to 6, where 0 = no symptoms (best outcome) and 6 = death (worst outcome). Lower scores indicate better functional outcomes. Scores were assessed by a blinded outcomes assessor at baseline. | Mean | Standard Deviation | units on a scale |
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| Baseline DBP (mmHg) | Baseline Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Number of Daily Medications ≥ 5 | Count of Participants | Participants |
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| Insurance Status | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Participants dropped out and in addition, the study was ended prematurely. | Posted | Count of Participants | Participants | 12 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| 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. | Posted | Mean | Standard Deviation | mmHg | 12 months |
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From randomization/enrollment until end of study follow-up at 12 months
Adverse events were assessed at each study visit (baseline, 4, 8, and 12 months) using structured questionnaires and clinical evaluations. ClinicalTrials.gov definitions for adverse events were applied; no substantive differences in definitions. Analysis population includes all participants who completed at least one follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 60 | 0 | 60 | 28 | 60 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 21 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Frequent urination (nocturia) | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue/weakness | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Constipation/diarrhea or stool changes | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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The study did not reach the planned sample size due to COVID-19 disruptions and funding loss, resulting in high attrition and limited power. Lack of a multidisciplinary telehealth component and community-based retention strategies may have reduced engagement. Investigators and participants were unblinded, though blinded evaluators assessed outcomes. Findings may be less generalizable beyond safety-net hospitals in the Southeastern U.S.
Findings will be submitted for peer-review publication.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Ovbiagele | San Francisco VA Medical Center | 415-750-2047 | bruce.ovbiagele@va.gov |
| Oct 23, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Medicare/Medicaid |
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| Both |
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| No insurance |
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