Phase 3
N=500
Phone-based Intervention Under Nurse Guidance After Stroke 2
Blood Pressure · Stroke · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04404166 ↗Enrolled (actual)
500
Serious AEs
9.0%
Results posted
Jan 2026
Primary outcome: Primary: Systolic Blood Pressure — 67; 43 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PINGS 2 (Behavioral); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northern California Institute of Research and Education
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure |
67; 43 | <0.001 sig |
| SECONDARY Self-management |
100; 103 | 0.14 |
| SECONDARY Number of Cardiovascular ED Encounters and Re-hospitalizations |
1; 2 | 0.9 |
| SECONDARY Number of Major Adverse Cardiovascular Events |
16; 12 | 0.5 |
| SECONDARY Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire |
76; 76 | 0.9 |
| SECONDARY Medication Adherence: Hill-Bone Compliance Scale |
51.5; 51.2 | 0.4 |
| SECONDARY Medication Adherence: Medication Possession Ratio (MPR) |
83; 85 | 0.4 |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04404166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.