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

NCT ID: NCT04157231

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2027-12-30

Brief Summary

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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

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A before and after, effectiveness-implementation hybrid study design with blinded outcome assessment will be conducted. This type 1 effectiveness-implementation hybrid design will test the essential acute stroke care management plan and secondarily gather data to inform subsequent research trials
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The clinical outcome will be assessed by a blinded assessor

Study Groups

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Usual Care

Usual care to be provided to patients as per hospital guidelines for 3 months

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Acute stroke care Intervention arm

Intervention Type OTHER

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. The aim of these sessions will be to educate stroke champions and other site staff on the management protocols. Available training resources will be accessed (including online materials) and simulation training will be used. New skills such as dysphagia assessment will be emphasized based on existing knowledge and competencies. After training, staff will have another assessment (Post-test) in order to determine whether they have been adequately trained and are able to adhere to the essential acute stroke care management plan. A standardised Power Point presentation and accompanying handouts will be made available for further use in the ward.

Refresher training will be provided monthly during the intervention.

Interventions

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Acute stroke care Intervention arm

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. The aim of these sessions will be to educate stroke champions and other site staff on the management protocols. Available training resources will be accessed (including online materials) and simulation training will be used. New skills such as dysphagia assessment will be emphasized based on existing knowledge and competencies. After training, staff will have another assessment (Post-test) in order to determine whether they have been adequately trained and are able to adhere to the essential acute stroke care management plan. A standardised Power Point presentation and accompanying handouts will be made available for further use in the ward.

Refresher training will be provided monthly during the intervention.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Heart Federation

UNKNOWN

Sponsor Role collaborator

The George Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Abanto, Dr

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurological Sciences, Lima, Peru

Kolawawole Wahab, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Ilorin & University of Ilorin Teaching Hospital Ilorin, Nigeria

Hasan Farhan, Professor

Role: PRINCIPAL_INVESTIGATOR

President of Iraqi Scientific Council of Cardiology,Iraq

Yi Sui, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenyang First People's Hospital Hospital Affiliated Brain Hospital

Saima Hilal, A/Professor

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Lily Song, Dr

Role: PRINCIPAL_INVESTIGATOR

The George Institute of Global Health, China

Craig Anderson, Professor

Role: PRINCIPAL_INVESTIGATOR

Executive Director The George Institute for Global Health - China

Locations

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Murtala Muhammad Specialist Hospital

Kano, Kano State, Nigeria

Site Status

Federal Medical Centre

Lokoja, Kogi State, Nigeria

Site Status

Hospital de Apoyo II-2 Sullana

Piura, , Peru

Site Status

Hospital de la Amistad Peru Corea Santa Rosa II-2

Piura, , Peru

Site Status

Countries

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Nigeria Peru

Central Contacts

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Cheryl Carcel, Dr

Role: CONTACT

+61 2 8052 4508

Rebecca Anderson

Role: CONTACT

Facility Contacts

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Dr Babatunde Ademiluyi, Dr

Role: primary

Other Identifiers

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GI_NM-01-2019

Identifier Type: -

Identifier Source: org_study_id

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