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Blood PressurePhase 3NCT04404166

Phone-based Intervention Under Nurse Guidance After Stroke 2

A Phase 3 study testing PINGS 2 in people with Blood Pressure and Stroke, run by Northern California Institute of Research and Education at 10 sites in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Blood Pressure, Stroke, Cardiovascular Diseases
What is being tested?
PINGS 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
10 sitesGhana
Study dates
23 Oct 2020to 5 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age ≥ 18 years (stroke is commoner above this age cut-off)
  • male or females (sex is a biologic variable of interest)
  • recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible
  • uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives <60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control
  • patients or family carers should own a basic mobile phone that can receive text/audio messages.

Who cannot join

  • Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Ghana10 sites

  • Ankaase Methodist Hospital

    Aboaso

  • Korle Bu Teaching Hospital

    Accra

  • Agogo Presbyterian Hospital

    Agogo

  • Cape Coast Teaching Hospital

    Cape Coast

  • Komfo Anokye Teaching Hospital

    Kumasi

  • Kumasi South Hospital

    Kumasi

  • Kwadaso SDA Hospital

    Kumasi

  • Kwame Nkrumah University of Science and Technology

    Kumasi

  • Manhyia Government Hospital

    Kumasi

  • Tafo Government Hospital

    Kumasi

Other trials in Ghana

About this study

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.

Being tested
PINGS 2, Standard of Care
Medical subject headings
Stroke, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PINGS 2Behavioural

    Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke

  • Standard of CareOther

    Standard of Care (routine post-stroke management per guidelines)

Study groups in NCT04404166
Study groupRoleWhat they receive
PINGS 2ExperimentalParticipants 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.
Receives: Behavioral: PINGS 2
Standard of CareActive comparatorParticipants 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.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (6)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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).

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start23 Oct 2020
  3. Primary completion5 Apr 2024
  4. Study completion5 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404166
Sponsor's protocol ID
20-30016
Other IDs
5R01HL152188-05
Status last verified
Jan 2026
First submitted
21 May 2020
Last updated
30 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41953982

  • 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.

    PubMed 40162227

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PINGS 2 in people with Blood Pressure and Stroke, run by Northern California Institute of Research and Education at 10 sites in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04404166, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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