Zambia Stroke Unit Study

NCT06457048 | Completed DMC

• 1 other identifier: IRB00447874
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the impact of a locally adapted stroke unit on outcomes of adults with stroke in Zambia. The main question\[s\] to answer are: • Does provision of evidence-based stroke care improve after implementation of a stroke unit at the University Teaching Hospital in Zambia? • Do patients cared for in a locally adapted stroke unit at the University Teaching Hospital in Zambia have better in-hospital and post-discharge outcomes that similar patients who were not cared for in the stroke unit? The investigators will collect data on the types of care participants receive during hospitalization and vital status (alive/dead) at the time of hospital discharge and at 90-days post-discharge. Researchers will compare patients enrolled in this study to a historical group of adults with stroke cared for at the same hospital prior to implementation of the stroke unit.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of clinical practice guidelines followed during inpatient admission

  Whether or not each individual clinical practice guideline is followed will be tracked each day of the participant's inpatient admission for stroke. The total proportion of clinical practice guidelines followed will then be calculated.

  <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)

Secondary Outcomes (6)

• In-hospital mortality

  Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days

• 90-day post-discharge mortality

  Duration of inpatient hospitalization + 90 days (likely to average < 100 days after enrollment)

• Functional status at 90-days post-discharge

  Duration of inpatient hospitalization + 90 days (likely to average <100 days after enrollment)

• Rate of aspiration pneumonia

  <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)

• Rate of decubitus ulcers

  <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)

Study Arms (2)

Stroke Unit Arm

EXPERIMENTAL

All participants in this study will be adults with stroke cared for in the recently implemented stroke unit at the University Teaching Hospital in Lusaka, Zambia. Of note, all adults with stroke admitted to the University Teaching Hospital during the study period will be cared for in the stroke unit regardless of participation participation in this study. However, only those who consent to study participation will have data collected.

Other: Stroke Unit

Pre-Stroke Unit Arm

NO INTERVENTION

This arm will consist of a historical cohort of adults with stroke admitted to the University Teaching Hospital in Lusaka, Zambia for the implementation of a stroke unit.

Interventions

Stroke Unit OTHER

The stroke unit at the University Teaching Hospital is a 12-bed unit on the general medical wards staffed by neurologists and nurses specifically trained in stroke care. This intervention includes new protocols and clinical practice guidelines that were developed by multiple stakeholders in Zambia to standardize stroke care, with a focus on early and consistent mobilization of patients with stroke, minimizing use of urinary catheters, provision of deep vein thrombosis prophylaxis, formal assessment of swallowing and assignment of modified diets as needed, and appropriate initiation of secondary prevention medications for stroke. Nurses and doctors working in this unit were trained on the new stroke unit protocols and are asked to follow these protocols in caring for patients with stroke admitted to the Stroke Unit.

Stroke Unit Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically suspected diagnosis of stroke by treating neurologist or imaging-confirmed diagnosis of stroke
• Symptom onset (last known normal) within 7 days of presentation to the University Teaching Hospital in Lusaka, Zambia
• Inpatient admission to the University Teaching Hospital in Lusaka, Zambia

You may not qualify if:

• Refusal to give informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, 00000, Zambia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Deanna Saylor, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Outcomes will be compared between a prospective post-intervention cohort enrolled for this study and a historical pre-intervention cohort.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: October 25, 2024
• Primary Completion: May 8, 2025
• Study Completion: August 17, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available one year after study completion for a period of three years.
• Access Criteria: All requests for study data will need to be approved by the study team and by both a Zambian IRB (University of Zambia Biomedical Ethics Regulatory Committee or Excellence Research Ethics \& Science (ERES) Converge IRB) and the Zambia National Health Research Authority prior to data sharing.

Locations

ZA (1)