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: Active, not recruiting
• Conditions: Cardiovascular Diseases; Stroke; Blood Pressure
• Intervention / Treatment: Behavioral: PINGS 2

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

Contacts and Locations

• Study Contact: Name: Raelle Tagge, MPH; Email: raelle.tagge@ncire.org
• Study Contact Backup: Name: Bruce Ovbiagele, MD; Phone Number: (415) 750-2047; Email: bruce.ovbiagele@va.gov

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: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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
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

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).	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, Age, 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.	12 months

Collaborators and Investigators

• Sponsor: Northern California Institute of Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2020
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): July 1, 2025

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): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Cardiovascular Diseases
• Other Study ID Numbers: 20-30016

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