Menu
Not yet recruiting NCT04157231

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

No phase Interventional Acute Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute stroke care Intervention arm.
Who it may be relevant to
Registry conditions: Acute Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria, Peru
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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 trainin

Primary outcome measures

  • Adherence [Time frame: 30 days]
Secondary outcome measures (1)
  • Death or disability [Time frame: 30 Days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Supportive care

Study locations

Nigeria · 2 centers
  • Murtala Muhammad Specialist Hospital — Kano
  • Federal Medical Centre — Lokoja
Peru · 2 centers
  • Hospital de Apoyo II-2 Sullana — Piura
  • Hospital de la Amistad Peru Corea Santa Rosa II-2 — Piura

Identifiers

NCT: NCT04157231 · GI_NM-01-2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗