Trial results for the Phone-based Intervention Under Nurse Guidance After Stroke 2 (PINGS-2) study were posted on 2026-01-30, indicating a significant improvement in systolic blood pressure control among stroke patients, with a 24.0% risk difference in achieving SBP <140 mmHg.
Background
Stroke is a major cause of disability and mortality worldwide, with effective management of risk factors like high blood pressure being crucial for preventing recurrent events. Post-stroke blood pressure control is a significant challenge, particularly in low- and middle-income countries (LMICs). Interventions that leverage mHealth technology and nurse guidance offer a potential pathway to improve long-term blood pressure control and reduce cardiovascular complications in this vulnerable population.
Trial design
The PINGS-2 study, a completed Phase 3 trial, enrolled 500 participants across 10 hospitals in Ghana. The study investigated conditions including Blood Pressure, Stroke, and Cardiovascular Diseases. The overall objective was to demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer-term blood pressure control among recent stroke patients. The primary endpoint was the proportion of participants achieving systolic blood pressure (SBP) <140 mmHg at 12 months. The intervention arm, PINGS 2, was compared against a Standard of Care arm.
Key results
Key analyses from the trial indicate:
- For Systolic Blood Pressure <140 mmHg at 12 months, there was a statistically significant difference between groups. The PINGS 2 group had 67 participants achieving this target, compared to 43 in the Standard of Care group. The analysis (Chi-squared) showed a Risk Difference (RD) of 24.0% (95% Confidence Interval: 15.0% to 33.0%) with a p-value of 0.001. This outcome was prespecified as the single primary endpoint.
- For Self-management (score on a scale of 60-240), the PINGS 2 group had a mean score of 100 (Standard Deviation 22), while the Standard of Care group had a mean score of 103 (Standard Deviation 24). The mean difference (t-test, 2 sided) was -3.5 (95% Confidence Interval: -8.3 to 1.2) with a p-value of 0.14.
- For the Number of Cardiovascular ED Encounters and Re-hospitalizations, 1 participant in the PINGS 2 group experienced an event, compared to 2 in the Standard of Care group. The risk difference (Fisher Exact) was -0.5% with a p-value of 0.9.
- For the Number of Major Adverse Cardiovascular Events (MACE), 16 participants in the PINGS 2 group experienced an event, compared to 12 in the Standard of Care group. The risk difference (Chi-squared) was 1.9% (95% Confidence Interval: -2.6% to 6.3%) with a p-value of 0.5.
- For Health-related Quality of Life (Euro Quality of Life-5D Questionnaire, score on a scale of 0-100), both the PINGS 2 and Standard of Care groups had a mean score of 76 (Standard Deviation 24). The mean difference (t-test, 2 sided) was 0.3 (95% Confidence Interval: -4.4 to 5.0) with a p-value of 0.9.
- For Medication Adherence (Hill-Bone Compliance Scale, score on a scale of 14-56), the PINGS 2 group had a mean score of 51.5 (Standard Deviation 2.9), and the Standard of Care group had a mean score of 51.2 (Standard Deviation 3.7). The mean difference (t-test, 2 sided) was 0.3 (95% Confidence Interval: -0.34 to 0.93) with a p-value of 0.4.
What this means
The results of the PINGS-2 trial demonstrate that a phone-based intervention under nurse guidance significantly improved systolic blood pressure control in stroke patients compared to standard of care. This finding suggests that such mHealth-centered approaches can be an effective strategy for managing post-stroke hypertension, particularly in settings like LMICs. While the intervention showed a clear benefit for the primary outcome of blood pressure control, other secondary outcomes such as self-management, cardiovascular ED encounters, MACE, quality of life, and medication adherence did not show statistically significant differences between the groups in this trial.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04404166, titled "Phone-based Intervention Under Nurse Guidance After Stroke 2", were posted on 2026-01-30 on clinicaltrials.gov.