Zanzibar Stroke Study: Narrowing the Gaps in Hypertension Care, and Improving Stroke Outcomes (ZanStroke)

NCT04095806 | Completed

• 1 other identifier: ZAHREC/02/July/2019/47
• Study Type: observational
• Target: 869
• Locations: 1 country
• Sites: 8

Brief Summary

Background: A previous study in Zanzibar (which Jutta Adelin Jorgensen, PI of ZanStroke, led) showed a high prevalence of hypertension among adults at 33%, in fact higher than average in Sub-Saharan Africa (SSA), and poor performance of the health systems with nearly 90% of people with hypertension not achieving adequate blood pressure control. Uncontrolled hypertension (HTN) and stroke have already become among the commonest causes of admission to and death at hospital in Zanzibar. At the same time, there is little or no data available to quantify the stroke burden on types, treatment and outcomes, cost of stroke care, nor a comprehensive understanding of the causes of poor hypertension control in the population.The Tanzanian Stroke Incidence study (which Richard Walker from Newcastle University led) showed some of the highest stroke incidence rates in the world. However, there are many unanswered questions, and the Zanzibar Stroke Study will be a unique opportunity to look at all stroke admissions from a large island population. Zanzibar Stroke Study: The hypotheses investigated are 1a. Current challenges in stroke care cannot exclusively be explained by limited structural resources, and care delivering processes play an essential role.

1. 1.b. Current organization and quality of care for stroke including rehabilitation could benefit from being aligned with best practices for low resource settings.
2. 2.a. Stroke types, causes, and prognosis are dominated by a higher proportion of hemorrhagic strokes, associated to poorly controlled hypertension, higher 30-day mortality, and worse prognosis in terms of disability and mortality at 12 months than seen in high income settings.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 30 day mortality

  Mortality rate of stroke patients 30 days post stroke

  30 days post stroke; data collected over 12 months

• 90 days mortality

  Mortality rate of stroke patients 90 days post stroke

  90 days post stroke; data collected over 12 months

• 12 months mortality

  Mortality rate of stroke patients 12 months post stroke

  12 months post stroke; data collected over 12 months

Secondary Outcomes (6)

• Disability at 30 days

  30 days post stroke; data collected over 12 months

• Disability at 12 months

  12 months post stroke; data collected over 12 months

• Cognitive impairment at 3 and 12 months

  3 and 12 months post stroke; data collected over 12 months

• Health related Quality of Life at 3 and 12 months

  3 and 12 months post stroke; data collected over 12 months

• Medicine Adherence at 3 and 12 months

  3 and 12 months post stroke; data collected over 12 months

Interventions

Stroke (exposure) OTHER

stroke case definition (exposure) listed in inclusion/exclusion criteria section

Eligibility Criteria

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

Study Population

All adults who get admitted to hospital in Unguja (Zanzibar) due to stroke, or develop stroke while admitted to hospital.

You may qualify if:

• admitted with a clinical diagnosis of stroke, or developing stroke while in hospital admitted for other cause (see below for stroke case definition)
• age above 18 year
• written consent form signed by patient, or authorized representative (spouse or caretaker)
• stroke onset \< 30 days when enrolled

You may not qualify if:

• patient or authorized representative unable to understand the information given or being interviewed.
• CT scan not suspect of stroke despite clinical suspect
• Stroke case definition:
• All the following stroke categories listed below that have been submitted as the most responsible diagnosis will be included in the stroke cohort. For patients developing stroke while admitted to hospital, stroke as the second diagnosis will also be included in the cohort. Patients who previously had a stroke and are being admitted due to complications, and where stroke is not the primary diagnosis during admission, will not be included in the cohort.
• (a) Intracerebral hemorrhage (I61 including all sub-codes) (b) Ischemic stroke (I63 including all sub-codes, H34.1) (c) Stroke, not specified as hemorrhagic or ischemic (I64) (d) Cerebral Venous Thrombosis, non-pyogenic (I63.6) Where CTscan is not available, the clinical diagnosis of stroke will be used, and coding will be I64 (ICD-10)

Sponsors & Collaborators

• Jutta Mari Adelin Jorgensen: lead
• Newcastle University, UK: collaborator
• Vervig (IoM): collaborator

Study Sites (8)

Kivunge District Hospital

Kinyasini, Zanzibar, Tanzania

Location

Mnazi Mmoja Hospital

Zanzibar, 236, Tanzania

Location

Al Rahma Hospital

Zanzibar, Tanzania

Location

Bububu Military Hospital

Zanzibar, Tanzania

Location

KMKM hospital Bububu

Zanzibar, Tanzania

Location

Makunduchi District hospital

Zanzibar, Tanzania

Location

Tasakthaa Global Hospital

Zanzibar, Tanzania

Location

Tawakala hospital

Zanzibar, Tanzania

Location

Related Publications (2)

• Jorgensen JA, Matuja SS. Establishing Stroke Registers in Sub-Saharan Africa: Experiences From 2 Large Referral Hospitals in Tanzania. Stroke. 2023 Sep;54(9):e417-e418. doi: 10.1161/STROKEAHA.123.043627. Epub 2023 Jul 14. No abstract available.

  PMID: 37449421 DERIVED

• Jorgensen JMA, Christensen DL, Nielsen KK, Sadiq HS, Khan MY, Jusabani AM, Walker R. Incidence and characteristics of stroke in Zanzibar-a hospital-based prospective study in a low-income island population. Front Neurol. 2022 Jul 28;13:931915. doi: 10.3389/fneur.2022.931915. eCollection 2022.

  PMID: 35968303 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample separated into fractions (RBC, buffy coat, plasma), serum, and whole blood will be stored for future studies (not part of the ZanStroke study)

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jutta A Jorgensen, MD

  Mnazi Mmoja Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator of ZanStroke, Dr. Jutta Mari Adelin Jorgensen

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: May 5, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

TA (8)