StrokeZASUSNCT06457048
Zambia Stroke Unit Study
A study testing Stroke Unit in people with Stroke, run by Johns Hopkins University at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke Unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteZambia
- Study dates
- 25 Oct 2024to 17 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Locally Adapted Stroke Unit to Improve Outcomes in Lusaka, Zambia
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.
Read the detailed description
The overarching goal of this project is to evaluate the uptake and impact of locally relevant, feasible, and generalizable stroke systems of care developed for the University Teaching Hospital (UTH) in Lusaka, Zambia using the Adopt-Contextualize-Adapt framework in order to improve stroke-related outcomes. Zambia is a country of ~20 million people in southern Africa where stroke is the eighth leading cause of death. However, stroke is not a problem unique to Zambia. Stroke is the second leading cause of adult disability and mortality worldwide. More than 75% of stroke-related morbidity and mortality occur in low- and middle-income countries (LMICs), and stroke prevalence in sub-Saharan Africa (SSA) is among the highest in the world. Yet, most stroke literature to date has been developed in high-income settings and its results applied to LMICs without adequate consideration of biological, ethnic, cultural and contextual differences. Diverse populations and settings in LMICs, including Zambia, necessitate evaluating unique risk factors, treatment strategies and systems of care in order to develop locally relevant interventions to improve stroke-related outcomes.
While acute stroke interventions (e.g., tissue plasminogen activator, endovascular therapies) have improved outcomes, indirect advances in stroke care have had a broader impact. Implementation of standardized systems of stroke care - i.e. stroke units - has led to secondary gains in stroke-related outcomes regardless of whether patients receive acute interventions. Compared to alternative care models, inpatient stroke unit care is associated with substantial reductions in death, dependency, and institutionalized care. In LMICs with limited access to specialists, neuroimaging, and acute stroke interventions, standardized systems of stroke care have not been instituted, including across Zambia and much of SSA. Absence of standardized systems of care likely accounts for higher rates of poor functional outcomes and mortality compared to higher-income settings.
Developing systems of stroke care in Zambia may improve stroke outcomes even in the absence of acute stroke interventions. Yet, simply instituting stroke clinical practice guidelines (CPGs) developed in high-income settings is unlikely to be successful without attention to differences in resource availability, health systems, and local contextual factors. Differences in biology (e.g. younger age, higher rates of HIV and rheumatic heart disease, differing risk factors) may also necessitate changes to stroke care delivery. As such, development of systems of stroke care in Zambia offers the promise of substantially improving stroke outcomes but must be done in a way in which stroke biology as well as cultural, patient, provider, and health systems factors are carefully considered during the design and implementation process.
Prior research characterized stroke care practices and stroke-related outcomes at the University Teaching Hospital (UTH) in Zambia. More recently, contextualized, locally relevant stroke CPGs were developed for UTH using the systematic guideline adaptation process of the Adopt-Contextualize-Adapt framework. These have recently been implemented as part of Zambia's first stroke unit. This project will assess the impact of local stroke CPGs on CPG adherence, stroke quality measures (QMs) and mortality through a post-intervention cohort of 300 adults with stroke. In this cohort, CPG uptake and in-hospital and post-discharge mortality will be measured and compared to a historical pre-intervention cohort of adults with stroke admitted to UTH before stroke unit implementation. If effective, results could potentially be applied across SSA thereby improving outcomes for millions of people with stroke.
- Conditions
- Stroke
- Being tested
- Stroke Unit
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke UnitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of 21 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 percentage of 21 key clinical practice guidelines followed will then be calculated.
Measured: <=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
Patients who die during the inpatient hospitalization for acute stroke
Measured: Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days
90-day Post-discharge Mortality
Patients who survive the inpatient hospitalization but die within 90 days of discharge as assessed by telephone call
Measured: 90-days (+/- 7 days) post-discharge (likely to average < 100 days after enrollment)
Functional Status as Measured by the Modified Rankin Scale at 90-days Post-discharge
Proportion of all participants with a modified Rankin Scale (mRS) score <2 at 90-days post-discharge. mRS was measured using the telephone version of the modified Rankin Scale, and all enrolled participants, including those who died prior to hospital discharge, were analyzed in this outcome. Scores range from 0 (no symptoms) to 6 (dead), with higher scores indicating greater disability.
Measured: 90-days (+/- 7 days) post-discharge from the index hospitalization
Participants With Aspiration Pneumonia
Aspiration pneumonia will be defined as >=4 of the following criteria: fever (temperature >38°C), tachypnea (respiratory rate >20), hypoxemia (oxygen saturation <92%), cough, rhonchi, witnessed aspiration event, initiation of antibiotics for clinically suspected aspiration pneumonia, leukocytosis (WBC >10,000) on complete blood count (CBC) or opacity on chest X-ray. These criteria will be assessed daily for the first 10 days of admission or until discharge, whichever comes first.
Measured: <=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)
Participants With Decubitus Ulcers
Presence or absence of decubitus ulcers will be assessed daily with a skin exam for the first ten days of inpatient hospitalization or until hospital discharge, whichever occurs first.
Measured: <=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)
Participants With Deep Vein Thrombosis
Patients diagnosed with a deep vein thrombosis confirmed on ultrasound during the first 10 days of hospitalization or until hospital discharge, whichever comes first.
Measured: <=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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Oct 2024
- Primary completion8 May 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Outcomes will be compared between a prospective post-intervention cohort enrolled for this study and a historical pre-intervention cohort.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Deanna Saylor, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457048
- Sponsor's protocol ID
- IRB00447874
- Acronym
- ZASUS
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2024
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocols and study materials as described below as well as a de-identified dataset will be shared if sharing criteria (described below) are met.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Locally Adapted Stroke Unit to Improve Outcomes in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT06457048
- Acronym / sponsor ID
- ZASUS / IRB00447874
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this project is to evaluate the uptake and impact of locally relevant, feasible, and generalizable stroke systems of care developed for the University Teaching Hospital (UTH) in Lusaka, Zambia using the Adopt-Contextualize-Adapt framework in order to improve stroke-related outcomes. Zambia is a country of ~20 million people in southern Africa where stroke is the eighth leading cause of death. However, stroke is not a problem unique to Zambia. Stroke is the second leading cause of adult disability and mortality worldwide. More than 75% of stroke-related morbidity and mortality occur in low- and middle-income countries (LMICs), and stroke prevalence in sub-Saharan Africa (SSA) is among the highest in the world. Yet, most stroke literature to date has been developed in high-income settings and its results applied to LMICs without adequate consideration of biological, ethnic, cultural and contextual differences. Diverse populations and settings in LMICs, including Zambia, necessitate evaluating unique risk factors, treatment strategies and systems of care in order to develop locally relevant interventions to improve stroke-related outcomes.
While acute stroke interventions (e.g., tissue plasminogen activator, endovascular therapies) have improved outcomes, indirect advances in stroke care have had a broader impact. Implementation of standardized systems of stroke care - i.e. stroke units - has led to secondary gains in stroke-related outcomes regardless of whether patients receive acute interventions. Compared to alternative care models, inpatient stroke unit care is associated with substantial reductions in death, dependency, and institutionalized care. In LMICs with limited access to specialists, neuroimaging, and acute stroke interventions, standardized systems of stroke care have not been instituted, including across Zambia and much of SSA. Absence of standardized systems of care likely accounts for higher rates of poor functional outcomes and mortality compared to higher-income settings.
Developing systems of stroke care in Zambia may improve stroke outcomes even in the absence of acute stroke interventions. Yet, simply instituting stroke clinical practice guidelines (CPGs) developed in high-income settings is unlikely to be successful without attention to differences in resource availability, health systems, and local contextual factors. Differences in biology (e.g. younger age, higher rates of HIV and rheumatic heart disease, differing risk factors) may also necessitate changes to stroke care delivery. As such, development of systems of stroke care in Zambia offers the promise of substantially improving stroke outcomes but must be done in a way in which stroke biology as well as cultural, patient, provider, and health systems factors are carefully considered during the design and implementation process.
Prior research characterized stroke care practices and stroke-related outcomes at the University Teaching Hospital (UTH) in Zambia. More recently, contextualized, locally relevant stroke CPGs were developed for UTH using the systematic guideline adaptation process of the Adopt-Contextualize-Adapt framework. These have recently been implemented as part of Zambia's first stroke unit. This project will assess the impact of local stroke CPGs on CPG adherence, stroke quality measures (QMs) and mortality through a post-intervention cohort of 300 adults with stroke. In this cohort, CPG uptake and in-hospital and post-discharge mortality will be measured and compared to a historical pre-intervention cohort of adults with stroke admitted to UTH before stroke unit implementation. If effective, results could potentially be applied across SSA thereby improving outcomes for millions of people with stroke.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Outcomes will be compared between a prospective post-intervention cohort enrolled for this study and a historical pre-intervention cohort.
| Arm | Type | Receives |
|---|---|---|
| Stroke Unit Arm | Experimental | Other: Stroke UnitAll 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke UnitThe 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. | Other | Stroke Unit Arm |
Primary outcome
Percentage of 21 Clinical Practice Guidelines Followed During Inpatient Admission
Time frame: <=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)
Whether or not each individual clinical practice guideline is followed will be tracked each day of the participant's inpatient admission for stroke. The percentage of 21 key clinical practice guidelines followed will then be calculated.
6 secondary outcomes
In-hospital Mortality
Time frame: Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days
90-day Post-discharge Mortality
Time frame: 90-days (+/- 7 days) post-discharge (likely to average < 100 days after enrollment)
Functional Status as Measured by the Modified Rankin Scale at 90-days Post-discharge
Time frame: 90-days (+/- 7 days) post-discharge from the index hospitalization
Participants With Aspiration Pneumonia
Time frame: <=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)
Participants With Decubitus Ulcers
Time frame: <=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)
Participants With Deep Vein Thrombosis
Time frame: <=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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study protocols and study materials as described below as well as a de-identified dataset will be shared if sharing criteria (described below) are met.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Saylor, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Unit in people with Stroke, run by Johns Hopkins University at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of 21 Clinical Practice Guidelines Followed During Inpatient Admission (time frame: <=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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.