Phone-based Intervention Under Nurse Guidance After Stroke 2

Stroke Clinical Trial

Official title:

Phone-based Intervention Under Nurse Guidance After Stroke 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04404166
• Other study ID #: 20-30016
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 28, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Northern California Institute of Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 1, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Stroke

Intervention

Behavioral:
• PINGS 2
Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke

Locations

Country	Name	City	State
Ghana	Ankaase Methodist Hospital	Aboaso
Ghana	Korle Bu Teaching Hospital	Accra
Ghana	Agogo Presbyterian Hospital	Agogo
Ghana	Cape Coast Teaching Hospital	Cape Coast
Ghana	Komfo Anokye Teaching Hospital	Kumasi
Ghana	Kumasi South Hospital	Kumasi
Ghana	Kwadaso SDA Hospital	Kumasi
Ghana	Kwame Nkrumah University of Science and Technology	Kumasi
Ghana	Manhyia Government Hospital	Kumasi
Ghana	Tafo Government Hospital	Kumasi

Sponsors (1)

Lead Sponsor	Collaborator
Northern California Institute of Research and Education

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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 (a.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice.	12 months
Secondary	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 (a.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
Secondary	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
Secondary	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
Secondary	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