Phone-based Intervention Under Nurse Guidance After Stroke 2

NCT04404166 | Completed Phase 3 Results DMC

• 2 other identifiers: 20-300165R01HL152188-05
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 10

Brief 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 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.

Conditions

Blood Pressure; Stroke; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (6)

• Self-management

  12 months

• Number of Cardiovascular ED Encounters and Re-hospitalizations

  12 months

• Number of Major Adverse Cardiovascular Events

  12 months

• Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire

  12 months

• Medication Adherence: Hill-Bone Compliance Scale

  12 months

Other Outcomes (4)

• Health Literacy in HPT/Stroke

  12 months

• Disability/Functional Status

  12 months

• Sex, Cultural, Socio-economic Factors, Study Site

  Baseline

Study Arms (2)

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.

Behavioral: PINGS 2

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.

Other: Standard of Care

Interventions

PINGS 2 BEHAVIORAL

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

PINGS 2

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (10)

Ankaase Methodist Hospital

Aboaso, Ghana

Location

Korle Bu Teaching Hospital

Accra, Ghana

Location

Agogo Presbyterian Hospital

Agogo, Ghana

Location

Cape Coast Teaching Hospital

Cape Coast, Ghana

Location

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Location

Kumasi South Hospital

Kumasi, Ghana

Location

Kwadaso SDA Hospital

Kumasi, Ghana

Location

Kwame Nkrumah University of Science and Technology

Kumasi, Ghana

Location

Manhyia Government Hospital

Kumasi, Ghana

Location

Tafo Government Hospital

Kumasi, Ghana

Location

Related Publications (1)

• 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.

  PMID: 40162227 DERIVED

MeSH Terms

Conditions

Stroke; Cardiovascular Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Bruce Ovbiagele
• Organization: San Francisco VA Medical Center

bruce.ovbiagele@va.gov

415-750-2047

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: October 23, 2020
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (10)