A Phase 3 interventional study of PINGS 2 and Standard of Care in Blood Pressure, Stroke and Cardiovascular Diseases, sponsored by Northern California Institute of Research and Education. Completed at 10 sites in Ghana. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Northern California Institute of Research and Education · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
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.
Behavioral: PINGS 2
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.
Other: Standard of Care
Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
Standard of Care (routine post-stroke management per guidelines)
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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).
| Milestone | PINGS 2 | Standard of Care |
|---|---|---|
| Started | 244 | 256 |
| Completed | 200 | 210 |
| Not completed | 44 | 46 |
Target goal of \<140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
| participants | PINGS 2 | Standard of Care |
|---|---|---|
| Systolic Blood Pressure | 67 (61 to 73) | 43 (37 to 49) |
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.
| score on a scale (60-240) | PINGS 2 | Standard of Care |
|---|---|---|
| Self-management | 100 ± 22 | 103 ± 24 |
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.
| participants | PINGS 2 | Standard of Care |
|---|---|---|
| Number of Cardiovascular ED Encounters and Re-hospitalizations | 1 | 2 |
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.
| participants | PINGS 2 | Standard of Care |
|---|---|---|
| Number of Major Adverse Cardiovascular Events | 16 | 12 |
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).
| Score on a scale (0-100) | PINGS 2 | Standard of Care |
|---|---|---|
| Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire | 76 ± 24 | 76 ± 24 |
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.
| score on a scale (14-56) | PINGS 2 | Standard of Care |
|---|---|---|
| Medication Adherence: Hill-Bone Compliance Scale | 51.5 ± 2.9 | 51.2 ± 3.7 |
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.
| percentage % | PINGS 2 | Standard of Care |
|---|---|---|
| Medication Adherence: Medication Possession Ratio (MPR) | 83 ± 22 | 85 ± 21 |
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.
| Score on a scale (0-15) | PINGS 2 | Standard of Care |
|---|---|---|
| Health Literacy in HPT/Stroke | 10 ± 2 | 9 ± 2 |
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.
| Score on a scale (0-6) | PINGS 2 | Standard of Care |
|---|---|---|
| Disability/Functional Status | 1.5 ± 1.3 | 1.6 ± 1.3 |
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.
| Participants | PINGS 2 | Standard of Care |
|---|---|---|
| Sex (Female) | 103 | 116 |
| Education (Primary or less) | 112 | 140 |
| Income (GHS less than or equal to 500) | 210 | 223 |
| Religion (Christianity) | 221 | 227 |
| Language Home (Akan) | 168 | 172 |
| Occupation (Informal/Self-employed) | 153 | 160 |
| Study site level (Tertiary) | 73 | 77 |
| Study stie level (Primary/Secondary) | 171 | 179 |
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.
| years | PINGS 2 | Standard of Care |
|---|---|---|
| Baseline Age | 58 ± 11 | 59 ± 11 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PINGS 2 | 14/244 (5.7%) | 27/244 (11.1%) | 0/244 (0%) |
| Standard of Care | 14/256 (5.5%) | 18/256 (7%) | 0/256 (0%) |
| Event | PINGS 2 | Standard of Care |
|---|---|---|
| Death (All-cause)General disorders | 14/244 | 14/256 |
| Sudden Cardiac DeathCardiac disorders | 10/244 | 9/256 |
| HospitalizationGeneral disorders | 7/244 | 3/256 |
| Recurrent StrokeNervous system disorders | 6/244 | 3/256 |
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.
| Age, Continuous(Years) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Mean | 58 ± 11 | 59 ± 11 | 58 ± 11 |
| Sex: Female, Male(Participants) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Female | 103 | 116 | 219 |
| Male | 141 | 140 | 281 |
| Race and Ethnicity Not Collected(Participants) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Ghana | 244 | 256 | 500 |
| Systolic BP(mmHg) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Mean | 157 ± 18 | 158 ± 20 | 158 ± 19 |
| Diastolic Blood Pressure(mmHg) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Mean | 94 ± 13 | 96 ± 15 | 95 ± 14 |
| Hemoglobin A1C(Percent) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Median | 6 (5 to 7) | 6 (5 to 7) | 6 (5 to 7) |
| NIHSS Stroke Severity(score on a scale) | PINGS 2 | Standard of Care | Total |
|---|---|---|---|
| Median | 3 (0 to 7) | 3 (0 to 8) | 3 (0 to 8) |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Northern California Institute of Research and Education