Trial Outcomes & Findings for Phone-based Intervention Under Nurse Guidance After Stroke 2 (NCT NCT04404166)
NCT ID: NCT04404166
Last Updated: 2026-01-30
Results Overview
Target goal of \<140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
12 months
Results posted on
2026-01-30
Participant Flow
Recruitment Period: First participant enrolled: October 23, 2020 Last participant enrolled: April 21, 2023 Last participant completed follow-up: April 5, 2024 Recruitment Locations: 10 hospitals in Ghana (3 tertiary, 2 district, 5 primary level). Urban, peri-urban, and rural populations. Recruitment Setting: Participants identified during acute stroke hospitalization or follow-up clinics. Stroke confirmed by CT (when feasible) or validated stroke-free questionnaire (QVSFS).
Screened: 905 potential participants. Excluded (n=405): Did not meet eligibility criteria: 243 Declined to participate: 162 Randomized: 500 participants
Participant milestones
| Measure |
PINGS 2
Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care.
Components included:
* Home blood pressure monitoring at least once weekly with nurse navigation for threshold breaches (using Omron 10 automated monitor).
* Mobile phone medication reminders (daily alarms set on participant's own phone).
* Weekly health education audio messages in local dialects (1-2 minutes, delivered via telephone).
* Nurse navigators were trained to provide case management, follow algorithms for BP thresholds, and coordinate clinic visits when needed.
|
Standard of Care
Participants received standard secondary prevention after stroke, according to local guidelines.
This typically included:
* Physician follow-up visits approximately every 2 months.
* Prescriptions for antihypertensive agents, antiplatelets, and statins at the clinician's discretion.
* To balance attention, participants in this group also received generic lifestyle SMS messages not related to medication adherence, hypertension, or stroke.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
256
|
|
Overall Study
COMPLETED
|
200
|
210
|
|
Overall Study
NOT COMPLETED
|
44
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PINGS 2
n=244 Participants
Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care.
Components included:
* Home blood pressure monitoring at least once weekly with nurse navigation for threshold breaches (using Omron 10 automated monitor).
* Mobile phone medication reminders (daily alarms set on participant's own phone).
* Weekly health education audio messages in local dialects (1-2 minutes, delivered via telephone).
* Nurse navigators were trained to provide case management, follow algorithms for BP thresholds, and coordinate clinic visits when needed.
|
Standard of Care
n=256 Participants
Participants received standard secondary prevention after stroke, according to local guidelines.
This typically included:
* Physician follow-up visits approximately every 2 months.
* Prescriptions for antihypertensive agents, antiplatelets, and statins at the clinician's discretion.
* To balance attention, participants in this group also received generic lifestyle SMS messages not related to medication adherence, hypertension, or stroke.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 Years
STANDARD_DEVIATION 11 • n=244 Participants
|
59 Years
STANDARD_DEVIATION 11 • n=256 Participants
|
58 Years
STANDARD_DEVIATION 11 • n=500 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=244 Participants
|
116 Participants
n=256 Participants
|
219 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=244 Participants
|
140 Participants
n=256 Participants
|
281 Participants
n=500 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Ghana
|
244 Participants
n=244 Participants
|
256 Participants
n=256 Participants
|
500 Participants
n=500 Participants
|
|
Systolic BP
|
157 mmHg
STANDARD_DEVIATION 18 • n=244 Participants
|
158 mmHg
STANDARD_DEVIATION 20 • n=256 Participants
|
158 mmHg
STANDARD_DEVIATION 19 • n=500 Participants
|
|
Diastolic Blood Pressure
|
94 mmHg
STANDARD_DEVIATION 13 • n=244 Participants
|
96 mmHg
STANDARD_DEVIATION 15 • n=256 Participants
|
95 mmHg
STANDARD_DEVIATION 14 • n=500 Participants
|
|
Hemoglobin A1C
|
6 Percent
n=244 Participants
|
6 Percent
n=256 Participants
|
6 Percent
n=500 Participants
|
|
NIHSS Stroke Severity
|
3 score on a scale
n=244 Participants
|
3 score on a scale
n=256 Participants
|
3 score on a scale
n=500 Participants
|
|
Modified Rankin Scale
|
2 score on a scale
n=244 Participants
|
2 score on a scale
n=256 Participants
|
2 score on a scale
n=500 Participants
|
|
Hill-Bone Adherence Score
|
52 score on a scale
n=244 Participants
|
52 score on a scale
n=256 Participants
|
52 score on a scale
n=500 Participants
|
|
Health Literacy Score
|
9 score on a scale
n=244 Participants
|
8 score on a scale
n=256 Participants
|
8 score on a scale
n=500 Participants
|
|
Quality of Life EQ-5D
|
70 score on a scale
n=244 Participants
|
70 score on a scale
n=256 Participants
|
70 score on a scale
n=500 Participants
|
|
Stroke Type
Ischemic
|
168 Participants
n=244 Participants
|
164 Participants
n=256 Participants
|
332 Participants
n=500 Participants
|
|
Stroke Type
ICH
|
45 Participants
n=244 Participants
|
58 Participants
n=256 Participants
|
103 Participants
n=500 Participants
|
|
Stroke Type
Hemorrhagic Transformation
|
8 Participants
n=244 Participants
|
2 Participants
n=256 Participants
|
10 Participants
n=500 Participants
|
|
Stroke Type
Untyped
|
23 Participants
n=244 Participants
|
32 Participants
n=256 Participants
|
55 Participants
n=500 Participants
|
|
Diabetes Mellitus
|
98 Participants
n=244 Participants
|
71 Participants
n=256 Participants
|
169 Participants
n=500 Participants
|
|
Hyperlipidemia
|
82 Participants
n=244 Participants
|
78 Participants
n=256 Participants
|
160 Participants
n=500 Participants
|
|
Cigarette Smoking
|
22 Participants
n=244 Participants
|
23 Participants
n=256 Participants
|
45 Participants
n=500 Participants
|
|
Overweight/Obesity
|
128 Participants
n=244 Participants
|
129 Participants
n=256 Participants
|
257 Participants
n=500 Participants
|
|
Alcohol Use (Current)
|
28 Participants
n=244 Participants
|
24 Participants
n=256 Participants
|
52 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
ACE Inhibitors
|
51 Participants
n=244 Participants
|
65 Participants
n=256 Participants
|
116 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
ARBs
|
115 Participants
n=244 Participants
|
115 Participants
n=256 Participants
|
230 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Betablockers
|
34 Participants
n=244 Participants
|
29 Participants
n=256 Participants
|
63 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Calcium Channel Blockers
|
200 Participants
n=244 Participants
|
198 Participants
n=256 Participants
|
398 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Diuretics
|
56 Participants
n=244 Participants
|
48 Participants
n=256 Participants
|
104 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Methyldopa
|
21 Participants
n=244 Participants
|
19 Participants
n=256 Participants
|
40 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Alpha Blockers
|
7 Participants
n=244 Participants
|
7 Participants
n=256 Participants
|
14 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Antiplatelets
|
148 Participants
n=244 Participants
|
151 Participants
n=256 Participants
|
299 Participants
n=500 Participants
|
|
Antihypertensive Medications at Baseline
Statins
|
176 Participants
n=244 Participants
|
186 Participants
n=256 Participants
|
362 Participants
n=500 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTarget goal of \<140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Systolic Blood Pressure
|
67 participants
Interval 61.0 to 73.0
|
43 participants
Interval 37.0 to 49.0
|
SECONDARY outcome
Timeframe: 12 monthsHypertension Self-Care Profile (HBP-SCP) Total Score, a validated measure assessing hypertension self-management across three domains: behavior, motivation, and self-efficacy. Each subscale ranges from 20 to 80, yielding a total score range of 60 to 240. Higher scores indicate better self-care. Month 12 total scores are reported.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Self-management
|
100 score on a scale (60-240)
Standard Deviation 22
|
103 score on a scale (60-240)
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All PINGS 2 completers were analyzed.
To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups. Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Number of Cardiovascular ED Encounters and Re-hospitalizations
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All PINGS 2 participants were analyzed (both completers and non completers)
Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital.
Outcome measures
| Measure |
PINGS 2
n=244 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=256 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Number of Major Adverse Cardiovascular Events
|
16 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 12 monthsThe EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status).
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire
|
76 Score on a scale (0-100)
Standard Deviation 24
|
76 Score on a scale (0-100)
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: participants with Month 12 data / completed follow-up.
Hill-Bone Compliance to High Blood Pressure Therapy Scale, a validated 14-item measure assessing adherence to antihypertensive therapy across three domains: medication-taking behavior, appointment keeping, and salt intake. Total scores range from 14 to 56, with higher scores indicating worse adherence (greater non-adherence). Month 12 total scores are reported.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Medication Adherence: Hill-Bone Compliance Scale
|
51.5 score on a scale (14-56)
Standard Deviation 2.9
|
51.2 score on a scale (14-56)
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: MPR collected for all randomized participants.
Medication Possession Ratio (MPR), calculated as the percentage of days covered by filled antihypertensive prescriptions over 12 months. Values range from 0% to 100%, with higher values indicating better adherence. Month 12 MPR values are reported.
Outcome measures
| Measure |
PINGS 2
n=244 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=256 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Medication Adherence: Medication Possession Ratio (MPR)
|
83 percentage %
Standard Deviation 22
|
85 percentage %
Standard Deviation 21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsSelf-Report: HTN/stroke Knowledge questionnaire (r=.70) Health literacy questionnaire (r = .74, .82) Assessed at months 0, 6,12. Higher scores indicate higher health literacy. Scales 1-5 are scored on a 4-point Likert-type response scale (strongly disagree, disagree, agree, strongly agree) and scales 6-9 are scored on a 5-point Likert-type scale with response options focusing on difficulty (cannot do or always difficult, usually difficult, sometimes difficult, usually easy, always easy). Month 12 is reported.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Health Literacy in HPT/Stroke
|
10 Score on a scale (0-15)
Standard Deviation 2
|
9 Score on a scale (0-15)
Standard Deviation 2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsFunctional status after stroke will be assessed by Research Assistants using the Modified Rankin Scale with a scores ranging from 0 to 6, where 0=no functional limitation and 6 = death. Assessed at months 0, 3, 6, 9 and 12.
Outcome measures
| Measure |
PINGS 2
n=200 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=210 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Disability/Functional Status
|
1.5 Score on a scale (0-6)
Standard Deviation 1.3
|
1.6 Score on a scale (0-6)
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAssessed based on self reports at baseline. Cultural factors to assess include language spoken at home, religious observances, acceptance of gender roles; occupation, religious beliefs and dietary practices.
Outcome measures
| Measure |
PINGS 2
n=244 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=256 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Sex, Cultural, Socio-economic Factors, Study Site
Sex (Female)
|
103 Participants
|
116 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Education (Primary or less)
|
112 Participants
|
140 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Income (GHS less than or equal to 500)
|
210 Participants
|
223 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Religion (Christianity)
|
221 Participants
|
227 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Language Home (Akan)
|
168 Participants
|
172 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Occupation (Informal/Self-employed)
|
153 Participants
|
160 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Study site level (Tertiary)
|
73 Participants
|
77 Participants
|
|
Sex, Cultural, Socio-economic Factors, Study Site
Study stie level (Primary/Secondary)
|
171 Participants
|
179 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMean age of participants at enrollment, reported in years. Age is a continuous baseline characteristic and is therefore reported separately from categorical sociodemographic variables. Higher values indicate older age.
Outcome measures
| Measure |
PINGS 2
n=244 Participants
PINGS 2: Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
|
Standard of Care
n=256 Participants
Usual post-stroke care per Ghanaian guidelines, including physician visits and prescriptions for secondary prevention. Received neutral lifestyle text messages unrelated to hypertension or stroke.
|
|---|---|---|
|
Baseline Age
|
58 years
Standard Deviation 11
|
59 years
Standard Deviation 11
|
Adverse Events
PINGS 2
Serious events: 27 serious events
Other events: 0 other events
Deaths: 14 deaths
Standard of Care
Serious events: 18 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
PINGS 2
n=244 participants at risk
Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care.
Components included:
* Home blood pressure monitoring at least once weekly with nurse navigation for threshold breaches (using Omron 10 automated monitor).
* Mobile phone medication reminders (daily alarms set on participant's own phone).
* Weekly health education audio messages in local dialects (1-2 minutes, delivered via telephone).
* Nurse navigators were trained to provide case management, follow algorithms for BP thresholds, and coordinate clinic visits when needed.
|
Standard of Care
n=256 participants at risk
Participants received standard secondary prevention after stroke, according to local guidelines.
This typically included:
* Physician follow-up visits approximately every 2 months.
* Prescriptions for antihypertensive agents, antiplatelets, and statins at the clinician's discretion.
* To balance attention, participants in this group also received generic lifestyle SMS messages not related to medication adherence, hypertension, or stroke.
|
|---|---|---|
|
General disorders
Death (All-cause)
|
5.7%
14/244 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
5.5%
14/256 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
|
General disorders
Hospitalization
|
2.9%
7/244 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
1.2%
3/256 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
|
Nervous system disorders
Recurrent Stroke
|
2.5%
6/244 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
1.2%
3/256 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
|
Cardiac disorders
Sudden Cardiac Death
|
4.1%
10/244 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
3.5%
9/256 • 12 months
Adverse events were actively monitored throughout the 12-month follow-up period during scheduled visits at months 1, 3, 6, 9, and 12, and through monthly phone contact. Serious adverse events were defined according to ICH-GCP as events resulting in death, life-threatening condition, hospitalization, disability, or congenital anomaly. Non-serious events were recorded if reported by participants or caregivers.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place