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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL152188-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer term BP control among 500 recent stroke patients encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation strategy for routine integration and policy adoption of mhealth for post-stroke BP control in a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain Disorders funded R21 pilot study (NS094033) to test efficacy of a refined, culturally-tailored, and potentially implementable intervention aimed at addressing the premier modifiable risk for stroke & other key variables in an under-resourced system burdened by suboptimal care & outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PINGS 2 | Experimental | Participants received a 12-month, multicomponent, nurse-led intervention in addition to usual post-stroke care. The intervention included: Home blood pressure monitoring at least weekly with nurse follow-up for threshold breaches. Mobile phone medication reminders (daily alarms set on the participant's own device). Weekly audio health education messages in local dialects emphasizing stroke risk factor control and medication adherence. Nurse navigators provided case management, coordinated clinic visits as needed, and tracked blood pressure readings and adherence. |
|
| Standard of Care | Active Comparator | Participants received standard secondary prevention after stroke according to local guidelines. This typically included periodic physician follow-up, antihypertensive therapy, antiplatelets, and statins prescribed at the clinician's discretion. To maintain contact frequency similar to the intervention group, participants received neutral lifestyle text messages unrelated to hypertension or stroke prevention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINGS 2 | Behavioral | Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Target goal of <140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-management | Hypertension 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Literacy in HPT/Stroke | Self-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. |
Inclusion Criteria:
Exclusion Criteria:
- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankaase Methodist Hospital | Aboaso | Ghana | ||||
| Korle Bu Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41953982 | Derived | Sarfo FS, Akpalu A, Bockarie AS, Nguah SB, Ayisi-Boateng NK, Adu Gyamfi R, Arthur AA, Duah C, Fiattor T, Agyenim-Boateng KG, Achab E, Appiah LT, Opare-Addo PA, Adamu S, Agbenorku M, Adusei-Mensah N, Tagge R, Ampofo M, Asibey SO, Laryea R, MacCready E, Sam VA, Buadu KA, Adu S, Adu Darko N, Agbogbatey M, Amuasi JH, Ovbiagele B. Phone-Based Intervention Under Nurse Guidance for Control of Hypertension After Stroke: A Randomized Multicenter Phase 3 Trial in Ghana. Circulation. 2026 Jun 16;153(24):1890-1902. doi: 10.1161/CIRCULATIONAHA.125.077424. Epub 2026 Apr 9. | |
| 40162227 |
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Screened: 905 potential participants.
Excluded (n=405):
Did not meet eligibility criteria: 243 Declined to participate: 162
Randomized: 500 participants
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | PINGS 2 | Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care. Components included:
|
| FG001 | Standard of Care | Participants received standard secondary prevention after stroke, according to local guidelines. This typically included:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics include all randomized participants who started the trial and completed baseline assessments (PINGS 2: n=244; Standard of Care: n=256; total n=500). These correspond to the 244 and 256 participants listed as 'Started' in the Participant Flow module. Twelve-month outcomes were analyzed in the subset who completed follow-up (PINGS 2: n=200; SOC: n=210), as shown in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | PINGS 2 | Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care. Components included:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | Target goal of <140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor. | Posted | Number | 95% Confidence Interval | participants | 12 months |
|
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.
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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 | PINGS 2 | Participants received a multicomponent, 12-month nurse-led intervention in addition to usual post-stroke care. Components included:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (All-cause) | General disorders | MedDRA Version 25.0 | Systematic Assessment | Includes all-cause mortality during 12-month follow-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Ovbiagele | San Francisco VA Medical Center | 415-750-2047 | bruce.ovbiagele@va.gov |
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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 | Jun 13, 2019 | Dec 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of Care (routine post-stroke management per guidelines) |
|
| Number of Cardiovascular ED Encounters and Re-hospitalizations | 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. | 12 months |
| Number of Major Adverse Cardiovascular Events | 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. | 12 months |
| Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire | The 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). | 12 months |
| Medication Adherence: Hill-Bone Compliance Scale | 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. | 12 months |
| Medication Adherence: Medication Possession Ratio (MPR) | 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. | 12 months |
| 12 months |
| Disability/Functional Status | Functional 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. | 12 months |
| Sex, Cultural, Socio-economic Factors, Study Site | Assessed 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. | Baseline |
| Baseline Age | Mean 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. | Baseline |
| Accra |
| Ghana |
| Agogo Presbyterian Hospital | Agogo | Ghana |
| Cape Coast Teaching Hospital | Cape Coast | Ghana |
| Komfo Anokye Teaching Hospital | Kumasi | Ghana |
| Kumasi South Hospital | Kumasi | Ghana |
| Kwadaso SDA Hospital | Kumasi | Ghana |
| Kwame Nkrumah University of Science and Technology | Kumasi | Ghana |
| Manhyia Government Hospital | Kumasi | Ghana |
| Tafo Government Hospital | Kumasi | Ghana |
| Derived |
| Bockarie AS, Ayisi-Boateng NK, Nguah SB, Appiah LT, Fiattor T, Afriyie-Ansah S, MacCready E, Sam VA, Mensah NA, Tagge R, Agyenim-Boateng KG, Ampofo M, Laryea R, Gyamfi RA, Amuasi JH, Arthur AA, Duah C, Opare-Addo PA, Ovbiagele B, Sarfo FS, Akpalu A. The Significance of the WHO/ISH Absolute Cardiovascular Risk Prediction Scores among Recent Stroke Survivors in Ghana-Insights from the PINGS2 multicenter study. Res Sq [Preprint]. 2025 Mar 12:rs.3.rs-6175913. doi: 10.21203/rs.3.rs-6175913/v1. |
| BG001 | Standard of Care | Participants received standard secondary prevention after stroke, according to local guidelines. This typically included:
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Systolic BP | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Hemoglobin A1C | Median | Inter-Quartile Range | Percent |
|
| NIHSS Stroke Severity | National Institutes of Health Stroke Scale (NIHSS), a standardized neurological impairment scale assessing level of consciousness, visual fields, motor strength, sensory function, language, and neglect. Scores range from 0 to 42, with higher values indicating more severe neurological deficit | Median | Inter-Quartile Range | score on a scale |
|
| Modified Rankin Scale | Modified Rankin Scale (mRS), a global functional disability scale assessing residual post-stroke functional limitations. Scores range from 0 (no symptoms) to 6 (death). Higher scores reflect worse functional status. | Median | Inter-Quartile Range | score on a scale |
|
| Hill-Bone Adherence Score | Hill-Bone Compliance to High Blood Pressure Therapy Scale, a validated 14-item adherence scale assessing medication-taking, appointment keeping, and dietary behavior. Total scores range from 14 to 56, with higher values indicating poorer adherence (i.e., worse compliance). Total score is calculated by summing item responses. | Median | Inter-Quartile Range | score on a scale |
|
| Health Literacy Score | Health Literacy Questionnaire, a validated 9-item instrument assessing understanding of hypertension and stroke. Items 1-5 use a 4-point Likert scale and items 6-9 use a 5-point difficulty scale. Total score ranges from 0 to 15, with higher scores indicating better health literacy. Total score is computed by summing all items. | Median | Inter-Quartile Range | score on a scale |
|
| Quality of Life EQ-5D | EuroQol 5-Dimension Visual Analog Scale (EQ-5D VAS), a self-reported measure of perceived overall health status. Scores range from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores reflecting better health-related quality of life. | Median | Inter-Quartile Range | score on a scale |
|
| Stroke Type | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Cigarette Smoking | Count of Participants | Participants |
|
| Overweight/Obesity | Count of Participants | Participants |
|
| Alcohol Use (Current) | Count of Participants | Participants |
|
| Antihypertensive Medications at Baseline | Note that subjects may be on more than one antihypertensive medication | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Self-management | Hypertension 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. | Posted | Mean | Standard Deviation | score on a scale (60-240) | 12 months |
|
|
|
|
| Secondary | Number of Cardiovascular ED Encounters and Re-hospitalizations | 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. | All PINGS 2 completers were analyzed. | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Number of Major Adverse Cardiovascular Events | 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. | All PINGS 2 participants were analyzed (both completers and non completers) | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire | The 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). | Posted | Mean | Standard Deviation | Score on a scale (0-100) | 12 months |
|
|
|
|
| Secondary | Medication Adherence: Hill-Bone Compliance Scale | 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. | participants with Month 12 data / completed follow-up. | Posted | Mean | Standard Deviation | score on a scale (14-56) | 12 months |
|
|
|
|
| Secondary | Medication Adherence: Medication Possession Ratio (MPR) | 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. | MPR collected for all randomized participants. | Posted | Mean | Standard Deviation | percentage % | 12 months |
|
|
|
|
| Other Pre-specified | Health Literacy in HPT/Stroke | Self-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. | Posted | Mean | Standard Deviation | Score on a scale (0-15) | 12 months |
|
|
|
|
| Other Pre-specified | Disability/Functional Status | Functional 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. | Posted | Mean | Standard Deviation | Score on a scale (0-6) | 12 months |
|
|
|
|
| Other Pre-specified | Sex, Cultural, Socio-economic Factors, Study Site | Assessed 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. | Posted | Number | Participants | Baseline |
|
|
|
| Other Pre-specified | Baseline Age | Mean 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. | Posted | Mean | Standard Deviation | years | Baseline |
|
|
|
| 14 |
| 244 |
| 27 |
| 244 |
| 0 |
| 244 |
| EG001 | Standard of Care | Participants received standard secondary prevention after stroke, according to local guidelines. This typically included:
| 14 | 256 | 18 | 256 | 0 | 256 |
|
| Hospitalization | General disorders | MedDRA Version 25.0 | Systematic Assessment | Hospital admissions unrelated to recurrent stroke, including infections, cardiovascular and metabolic complications. |
|
| Recurrent Stroke | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment | Includes fatal, disabling, or non-fatal recurrent strokes confirmed by imaging or adjudication. |
|
| Sudden Cardiac Death | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| Hemorrhagic Transformation |
|
| Untyped |
|
| Superiority |
| Income (GHS less than or equal to 500) |
|
| Religion (Christianity) |
|
| Language Home (Akan) |
|
| Occupation (Informal/Self-employed) |
|
| Study site level (Tertiary) |
|
| Study stie level (Primary/Secondary) |
|