Phone-based Intervention Under Nurse Guidance After Stroke 2

Study Overview
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Brief Summary
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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.

Official Title
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Phone-based Intervention Under Nurse Guidance After Stroke 2

Conditions
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Blood Pressure, Stroke, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: PINGS 2


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PINGS 2<br> | Behavioral: PINGS 2<br>* Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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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 |
| --- | --- | --- |
| Self-management | Compared between the two groups using the validated Hypertension Self-care Profile questionnaire (HBP SCP) with items that compositely assesses behavior, motivation and self-efficacy of hypertension management. Assessed at months 4, 8 and 12 (α.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice. | 12 months | 
| Medication adherence | Measured using Medication possession ratio177 and 14-item Hill-Bone compliance (HBC) to high blood pressure therapy scale with items that assess medication adherence, clinic appointments and salt intake assessed at months 3, 6, 9 and 12 (α.76-.83, r = .64) MPR and HBC will be measured in both PINGS and usual care arms at stated time points. Higher scores (0-14) indicate lower adherence (i.e. higher non adherence). | 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 | 
| 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 | 
| 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 |