Trial Outcomes & Findings for PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor (NCT NCT03401489)
NCT ID: NCT03401489
Last Updated: 2025-12-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
12 months
Results posted on
2025-12-11
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
26
|
21
|
|
Overall Study
NOT COMPLETED
|
34
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor
Baseline characteristics by cohort
| Measure |
Total
n=120 Participants
Total of all reporting groups
|
PACESETTER
n=60 Participants
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.
|
Healthy Lifestyle Intervention Group
n=60 Participants
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.
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.6 • n=9 Participants
|
61.1 years
STANDARD_DEVIATION 10.2 • n=9 Participants
|
59.7 years
STANDARD_DEVIATION 10.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=9 Participants
|
25 Participants
n=9 Participants
|
27 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=9 Participants
|
35 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=9 Participants
|
39 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=9 Participants
|
21 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=9 Participants
|
60 Participants
n=9 Participants
|
60 Participants
n=6 Participants
|
|
Modified Rankin Score (mRS)
|
1.85 units on a scale
STANDARD_DEVIATION 0.85 • n=9 Participants
|
1.8 units on a scale
STANDARD_DEVIATION .09 • n=9 Participants
|
1.9 units on a scale
STANDARD_DEVIATION .08 • n=6 Participants
|
|
Baseline DBP (mmHg)
|
86.9 mmHg
STANDARD_DEVIATION 11.5 • n=9 Participants
|
85.7 mmHg
STANDARD_DEVIATION 12.8 • n=9 Participants
|
88 mmHg
STANDARD_DEVIATION 10.1 • n=6 Participants
|
|
Number of Daily Medications ≥ 5
|
82 Participants
n=9 Participants
|
43 Participants
n=9 Participants
|
39 Participants
n=6 Participants
|
|
Insurance Status
Private
|
48 Participants
n=9 Participants
|
24 Participants
n=9 Participants
|
24 Participants
n=6 Participants
|
|
Insurance Status
Medicare/Medicaid
|
40 Participants
n=9 Participants
|
23 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
|
Insurance Status
Both
|
20 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
|
Insurance Status
No insurance
|
12 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants dropped out and in addition, the study was ended prematurely.
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.
Outcome measures
| Measure |
PACESETTER
n=32 Participants
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.
|
Healthy Lifestyle Intervention Group
n=40 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
PACESETTER
n=32 Participants
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.
|
Healthy Lifestyle Intervention Group
n=40 Participants
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.
|
|---|---|---|
|
Mean Systolic Blood Pressure at 12 Months
|
132.5 mmHg
Standard Deviation 20.8
|
134.9 mmHg
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 12 monthsClinic 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.
Outcome measures
| Measure |
PACESETTER
n=32 Participants
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.
|
Healthy Lifestyle Intervention Group
n=40 Participants
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.
|
|---|---|---|
|
Mean Diastolic Blood Pressure at 12 Months
|
85.7 mmHg
Standard Deviation 12.8
|
88 mmHg
Standard Deviation 12.1
|
Adverse Events
PACESETTER
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Healthy Lifestyle Intervention Group
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PACESETTER
n=60 participants at risk
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.
|
Healthy Lifestyle Intervention Group
n=60 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Frequent urination (nocturia)
|
20.0%
12/60 • 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.
|
16.7%
10/60 • 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.
|
|
General disorders
Fatigue/weakness
|
15.0%
9/60 • 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.
|
10.0%
6/60 • 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.
|
|
Gastrointestinal disorders
Constipation/diarrhea or stool changes
|
11.7%
7/60 • 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.
|
8.3%
5/60 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place