Phone-based Intervention Under Nurse Guidance After Stroke 2

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Stroke; Blood Pressure
• Intervention / Treatment: Behavioral: PINGS 2; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ghana
  • Aboaso, Ghana
    • Ankaase Methodist Hospital
  • Accra, Ghana
    • Korle Bu Teaching Hospital
  • Agogo, Ghana
    • Agogo Presbyterian Hospital
  • Cape Coast, Ghana
    • Cape Coast Teaching Hospital
  • Kumasi, Ghana
    • Komfo Anokye Teaching Hospital
  • Kumasi, Ghana
    • Kwame Nkrumah University of Science and Technology
  • Kumasi, Ghana
    • Kumasi South Hospital
  • Kumasi, Ghana
    • Kwadaso SDA Hospital
  • Kumasi, Ghana
    • Manhyia Government Hospital
  • Kumasi, Ghana
    • Tafo Government Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PINGS 2; 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; Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke
Active Comparator: Standard of Care; 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; Standard of Care (routine post-stroke management per guidelines)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Northern California Institute of Research and Education
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Stroke; Cardiovascular Diseases; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 20-30016; 5R01HL152188-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No