Clinical trial NCT04157231: Essential Acute Stroke Care in Low Resource Settings: a Pilot studY
Official title: Essential Acute Stroke Care in Low Resource Settings: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Stroke
Keywords: Stroke
Ischemic stroke
hemorrhagic stroke
stroke package
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: World Heart Federation
First posted: 2019-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: 30 days
Secondary outcomes:
measure: Death or disability
timeFrame: 30 Days
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Murtala Muhammad Specialist Hospital
state: Kano State
city: Lokoja
country: Nigeria
facility: Federal Medical Centre
state: Kogi State
city: Piura
country: Peru
facility: Hospital de Apoyo II-2 Sullana
city: Piura
country: Peru
facility: Hospital de la Amistad Peru Corea Santa Rosa II-2
Study officials:
affiliation: National Institute of Neurological Sciences, Lima, Peru
name: Carlos Abanto, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ilorin & University of Ilorin Teaching Hospital Ilorin, Nigeria
name: Kolawawole Wahab, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: President of Iraqi Scientific Council of Cardiology,Iraq
name: Hasan Farhan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang First People's Hospital Hospital Affiliated Brain Hospital
name: Yi Sui, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Singapore
name: Saima Hilal, A/Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute of Global Health, China
name: Lily Song, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Executive Director The George Institute for Global Health - China
name: Craig Anderson, Professor
role: PRINCIPAL_INVESTIGATOR
References: