Trial Outcomes & Findings for Zambia Stroke Unit Study (NCT NCT06457048)
NCT ID: NCT06457048
Last Updated: 2026-07-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
<=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 posted on
2026-07-28
Participant Flow
Participant milestones
| Measure |
Stroke Unit Arm
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.
Stroke Unit: 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.
|
Pre-Stroke Unit Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
300
|
300
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zambia Stroke Unit Study
Baseline characteristics by cohort
| Measure |
Stroke Unit Arm
n=300 Participants
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.
Stroke Unit: 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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
HIV
|
51 Participants
n=20 Participants
|
64 Participants
n=20 Participants
|
115 Participants
n=40 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 16 • n=20 Participants
|
57 years
STANDARD_DEVIATION 16 • n=20 Participants
|
59 years
STANDARD_DEVIATION 16 • n=40 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=20 Participants
|
154 Participants
n=20 Participants
|
322 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=20 Participants
|
146 Participants
n=20 Participants
|
278 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
300 Participants
n=20 Participants
|
300 Participants
n=20 Participants
|
600 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Zambia
|
300 participants
n=20 Participants
|
300 participants
n=20 Participants
|
600 participants
n=40 Participants
|
|
Stroke Type
Ischemic Stroke
|
183 Participants
n=20 Participants
|
140 Participants
n=20 Participants
|
323 Participants
n=40 Participants
|
|
Stroke Type
Intracerebral Hemorrhage
|
105 Participants
n=20 Participants
|
97 Participants
n=20 Participants
|
202 Participants
n=40 Participants
|
|
Stroke Type
Unknown Stroke (i.e. no imaging obtained)
|
12 Participants
n=20 Participants
|
63 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: <=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.
Outcome measures
| Measure |
Stroke Unit Arm
n=300 Participants
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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
|---|---|---|
|
Percentage of 21 Clinical Practice Guidelines Followed During Inpatient Admission
|
80 percentage of guidelines
Standard Deviation 10
|
57 percentage of guidelines
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 daysPatients who die during the inpatient hospitalization for acute stroke
Outcome measures
| Measure |
Stroke Unit Arm
n=300 Participants
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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
|---|---|---|
|
In-hospital Mortality
|
61 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 90-days (+/- 7 days) post-discharge (likely to average < 100 days after enrollment)Population: four lost to follow-up in stroke unit arm; 21 lost to follow-up in pre-stroke unit arm
Patients who survive the inpatient hospitalization but die within 90 days of discharge as assessed by telephone call
Outcome measures
| Measure |
Stroke Unit Arm
n=235 Participants
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.
|
Pre-Stroke Unit Arm
n=216 Participants
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.
|
|---|---|---|
|
90-day Post-discharge Mortality
|
44 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 90-days (+/- 7 days) post-discharge from the index hospitalizationPopulation: 8 (3%) lost-to-follow-up in the stroke unit arm and 152 (51%) lost to follow-up in the pre-intervention arm.
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.
Outcome measures
| Measure |
Stroke Unit Arm
n=292 Participants
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.
|
Pre-Stroke Unit Arm
n=148 Participants
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.
|
|---|---|---|
|
Functional Status as Measured by the Modified Rankin Scale at 90-days Post-discharge
|
41 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: <=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)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.
Outcome measures
| Measure |
Stroke Unit Arm
n=300 Participants
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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
|---|---|---|
|
Participants With Aspiration Pneumonia
|
30 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: <=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)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.
Outcome measures
| Measure |
Stroke Unit Arm
n=300 Participants
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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
|---|---|---|
|
Participants With Decubitus Ulcers
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: <=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)Patients diagnosed with a deep vein thrombosis confirmed on ultrasound during the first 10 days of hospitalization or until hospital discharge, whichever comes first.
Outcome measures
| Measure |
Stroke Unit Arm
n=300 Participants
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.
|
Pre-Stroke Unit Arm
n=300 Participants
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.
|
|---|---|---|
|
Participants With Deep Vein Thrombosis
|
7 Participants
|
10 Participants
|
Adverse Events
Stroke Unit Arm
Serious events: 88 serious events
Other events: 17 other events
Deaths: 105 deaths
Pre-Stroke Unit Arm
Serious events: 60 serious events
Other events: 11 other events
Deaths: 97 deaths
Serious adverse events
| Measure |
Stroke Unit Arm
n=300 participants at risk
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.
Stroke Unit: 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.
|
Pre-Stroke Unit Arm
n=300 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/300 • Duration of inpatient hospitalization + 90 days
|
0.00%
0/300 • Duration of inpatient hospitalization + 90 days
|
|
Nervous system disorders
Recurrent stroke
|
0.00%
0/300 • Duration of inpatient hospitalization + 90 days
|
0.00%
0/300 • Duration of inpatient hospitalization + 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
5/300 • Number of events 5 • Duration of inpatient hospitalization + 90 days
|
1.3%
4/300 • Number of events 4 • Duration of inpatient hospitalization + 90 days
|
|
Nervous system disorders
Seizure
|
16.0%
48/300 • Number of events 120 • Duration of inpatient hospitalization + 90 days
|
8.3%
25/300 • Number of events 32 • Duration of inpatient hospitalization + 90 days
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.3%
7/300 • Number of events 7 • Duration of inpatient hospitalization + 90 days
|
3.3%
10/300 • Number of events 10 • Duration of inpatient hospitalization + 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
10.0%
30/300 • Number of events 30 • Duration of inpatient hospitalization + 90 days
|
7.7%
23/300 • Number of events 23 • Duration of inpatient hospitalization + 90 days
|
Other adverse events
| Measure |
Stroke Unit Arm
n=300 participants at risk
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.
Stroke Unit: 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.
|
Pre-Stroke Unit Arm
n=300 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
5.7%
17/300 • Number of events 17 • Duration of inpatient hospitalization + 90 days
|
3.7%
11/300 • Number of events 11 • Duration of inpatient hospitalization + 90 days
|
Additional Information
Dr. Deanna Saylor, Associate Professor of Neurology and PI
Univeresity of North Carolina - Chapel Hill
Phone: 9199668179
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place