Essential Acute Stroke Care in Low Resource Settings: a Pilot studY

Not Applicable

Not yet recruiting

• Conditions: Acute Stroke
• Interventions: Other: Acute stroke care Intervention arm

• Registration Number: NCT04157231
• Lead Sponsor: The George Institute

Brief Summary

An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting

Detailed Description

This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.

Study Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Study Start: 2025-12-30
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adults (age ≥18 years)
• A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset
• Provision of written informed consent
• Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

Exclusion Criteria

• Patients who have undergone intravenous thrombolysis or mechanical thrombectomy
• Patients who are planned for transfer to the intensive care unit
• Subarachnoid haemorrhage
• Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Acute stroke care Intervention arm	The intervention consists of training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. This intervention will run for 3 months. Refresher training will be given monthly during the intervention.

Primary Outcome Measures

Name	Time	Method
Adherence	30 days	Primary Outcome Measure: Adherence to the predefined components of the essential acute stroke care management plan Adherence will be expressed as all or none measure and is defined as the proportion of patients who receive all the components of acute stroke care management for which the patient is eligible. Adherence will also be expressed as a composite measure, which is defined as the total number of eligible components performed divided by the total number of components for which the patient was eligible.

Secondary Outcome Measures

Name	Time	Method
Death or disability	30 Days	Death or disability as measured by Modified Rankin Scale (mRS) at 30 days. The mRS is a disability scale that ranges from 0 (no symptoms) to 6 (death).

Trial Locations

Locations (4)

Murtala Muhammad Specialist Hospital; 🇳🇬 Kano, Kano State, Nigeria

Hospital de Apoyo II-2 Sullana; 🇵🇪 Piura, Peru

Hospital de la Amistad Peru Corea Santa Rosa II-2; 🇵🇪 Piura, Peru

Federal Medical Centre; 🇳🇬 Lokoja, Kogi State, Nigeria