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. Author manuscript; available in PMC: 2023 Jan 15.
Published in final edited form as: Neuroepidemiology. 2021 Nov 25;56(1):17–24. doi: 10.1159/000518885

AFRICAN RIGOROUS INNOVATIVE STROKE EPIDEMIOLOGICAL SURVEILLANCE (ARISES): PROTOCOL FOR A COMMUNITY-BASED MOBILE-HEALTH STUDY

Oluwafemi Popoola 1, Bruce Ovbiagele 2, Oyedunni Arulogun 3, Joshua Akinyemi 4, Rufus Akinyemi 5,6, Ezinne Uvere 11, Onoja Akpa 4, Ayodeji Salami 7, Olalekan Taiwo 8, Lanre Olaniyan 9, Richard Walker 10, Carolyn Jenkins 11, Mayowa Owolabi 6,12
PMCID: PMC9840813  NIHMSID: NIHMS1740932  PMID: 34903691

Abstract

Despite projections of stroke being a leading cause of mortality in Africa, reliable estimates of stroke burden on the continent using rigorous methods are not available. We aimed to implement a mobile-Health community-based interactive Stroke Information and Surveillance System to sustainably measure stroke burden and improve stroke health literacy and outcomes in urban and rural sites in Nigeria. African Rigorous Innovative Stroke Epidemiological Surveillance (ARISES) is an observational cohort study which will be conducted in urban (Ibadan North LGA Ward 3) and rural (Ibarapa Central LGA) sites with a combined base population of over 80,000 people. The study will use a consultative approach to establish an mHealth-based Stroke Information and Surveillance System comprising a Stroke Alert System and a Stroke Finding System. These systems will enable the community to report stroke events and the research team/health workers find stroke cases using phone calls, short message service (SMS) and Voice Over Internet Protocols (VoIP). We will update community household data and geo-locate all households. Over the five years of the study, the system will collect information on stroke events and educate the community about this disease. Reported stroke cases will be clinically adjudicated at home and in pre-specified health facilities. Baseline and endline community surveys will be conducted to assess stroke occurrence and other important study variables. The proportion of strokes alerted and found will be determined over the study period. Focus group discussions and key informant interviews will be conducted to understand community stroke literacy and perspectives. The study will also assess any impact of these efforts on time from stroke onset to referral, community uptake of orthodox health services for stroke patients. ARISES is anticipated to establish proof of concept about using mHealth for stroke surveillance in Africa. The potential impact of the SISS on improving patient outcomes will also be determined.

Keywords: Stroke, Africa, Surveillance, mHealth, prevalence

INTRODUCTION

Stroke is a leading cause of death and disability globally [1]; but its precise burden is unclear in Low and Middle-Income Countries (LMIC), particularly in Africa [2–5]. Unlike other more technologically advanced regions of the world with robust systems for managing epidemiologic data, often quoted regional and national estimates of stroke burden in Africa come from the Global Burden of Disease (GBD) [1,6] studies which are mostly derived from models which use the available but scanty and often unreliable data [1,5,7,8]. One of the largest community based stroke incidence studies derived age standardised annual stroke incidence figures of 108.6 and 315.9 per 100,000 in rural and urban areas of Tanzania respectively with significant age and sex differences [9]. However, existing studies show wide differences in stroke prevalence and incidence values in Africa. This wide disparity in crude prevalence of stroke (ranging from 15/100,000 in Ethiopia [2,10,11] to 1,331/100,000 in Nigeria [12–14] might reflect true epidemiological differences or uneven methodological rigor of the studies even after accounting for geographical and period effects. Prevalence depends on incidence and duration of stroke among survivors and is best estimated from studies which also track first-ever stroke and survival [11,15]. However, in Africa such studies are rare [3,8,11,15,16].

Stroke surveillance systems which help greatly in tracking the actual burden of stroke, its epidemiological trends, determinants and outcomes are almost non-existent in LMICs where these data are needed most [17]. Such efforts in Africa are hampered by factors such as poor health access, limitations in diagnostic capacity due to manpower and technical deficiencies, outmoded paper-based records systems which are prone to data losses. Various tools may be employed to address these shortcomings, of which an important one is electronic/mobile platforms. Electronic surveillance (e-surveillance) is a tool which can be useful for rigorous stroke surveillance. An electronic surveillance system can utilise mobile-health technology which provides real-time community-based data on the actual burden and determinants of stroke in Africa. Such a system can also incorporate key clinical element[18]s of index strokes to inform better management of stroke events.

ARISES will leverage on knowledge and resources this project team has gained in executing prior stroke studies such as SIREN and THRIVES[18,19]. The SIREN (Stroke Investigative Research and Education Network) project was a multi-centre case control study across Ghana and Nigeria which characterised stroke phenotype and risk factors in 6,000 individuals. Findings such as high penetrance of mobile phones and the network of SIREN hospitals will aid ARISES implementation[18].

METHODS

Study Aims and Hypotheses

ARISES has three specific aims viz: To develop and validate an innovative interactive mobile-health-driven community-based SISS in the selected urban (Ibadan) and rural (Igbo Ora) demographic surveillance sites (DSS) in Nigeria as a scalable effective model that can be useful in other countries for enhancing immediate stroke recognition, early complete notification and timely presentation (reduced onset-to-door time) in appropriate healthcare facilities. This Stroke Information and Surveillance System comprises community sensitization/engagement, stroke alert system and stroke finding system (see Figure 1). We hypothesise that the surveillance system will capture at least 80% of the cases detected by door-to-door survey in the DSS, cause an 80% increase in the number of stroke patients with onset-to-door time < 6 hours and produce a 50% reduction in the mean onset-to-door time at end line compared to baseline.

Figure 1. Stroke Information and Surveillance System (SISS).

Figure 1

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SISS comprises:

1) Community Engagement to enhance stroke literacy, recognition and reporting

2) SAS: Stroke Alert System for timely report of stroke cases by community members &

3) SFS: Stroke Finding System for health-workers to remotely elicit stroke report from the communities.

CAB: Community advisory board. DSS: Demographic surveillance site Information obtained from the community through focus group discussions and interviews will be processed by the community engagement team which will provide

feedback to the community to enhance stroke literacy and surveillance.

Integrated databases indude REDCap and ACCESS databases for phenotype and neuroimaging data; Freezerworks for laboratory sample information; geotagged DSS data and spatial data.

The second aim is to determine the stroke prevalence at these sites over a 36-month period. We will test the assumptions that new age-adjusted stroke prevalence will be at least twice as high as the 1983 figures [17,20] and that socioeconomic and demographic factors will be associated with stroke occurrence. Finally, we will integrate the Stroke Information and Surveillance System into a sustainable care matrix to improve stroke outcome and wider public health education and surveillance in the DSS. We hypothesise this will improve 1-month stroke outcome at end-line (Year 4/5) compared to baseline (Year 2).

Study Setting

The ARISES project sites are Ibarapa Central LGA (rural; also referred to as Igbo-Ora) and Ward 3 in the Ibadan North LGA (urban) of Nigeria. Since 1963, the University of Ibadan; has run a rural health in Ibarapa [20,21]. A demographic survey conducted there in 2013 during the CAPBID study revealed a de jure population of 64,431 (16,311 households) [22]. The Ibadan North LGA hosts the University of Ibadan, the prime institution for ARISES. Ward 3 (one of the LGA’s 10 wards) has been adopted as an urban health project site by the Department of Community Medicine. Preliminary estimates indicate that about 18,722 individuals (in 6,456 households) reside in the area.

Ibarapa Central and Ibadan North Ward 3 are typical rural and urban areas respectively in Nigeria. Data from the Nigerian Demographic and Health Survey shows that the age and sex structure of rural and urban household populations is very similar across the six geo-political zones [22]. As such, findings from our study could be generalizable to urban and rural localities across Nigeria and possibly similar LMIC settings. The choice of location is also influenced by availability of prior stroke prevalence data, which will allow direct comparison [17,23] to establish the difference across time.

Study approach

Community engagement, stroke literacy and deploying the Stroke Information and Surveillance System

Community engagement and assessments of community stroke health literacy:

Leveraging existing collaborations with the study sites, we will provide widespread awareness about ARISES, gain acceptance for its objectives, and educate the community about stroke, its risk factors, prevention and symptoms. We will integrate existing community partners from previous studies with new members to set up community advisory boards for the project [24,25]. Board members will provide input and feedback to the ARISES Steering Committee. Settlements will be engaged through the existing ward health committees. We will also purposively engage the Medical Officers of Health; community leaders, traditional medical practitioners and faith healers, physicians, nurses, physiotherapists and pharmacists individually and through professional associations. Public viewings of a stroke education video with follow up question and answer sessions will be conducted to enhance engagement and improve local understanding of stroke. A description of the stroke video and other tools from prior research is included in the supplementary material.

Using an explanatory sequential mixed methods design [26,27], we will explore the role of demographic; socio-cultural factors and other factors as barriers/facilitators of stroke recognition, notification and early presentation; and awareness of dominant modifiable stroke risk factors. Focus group discussions with community members (n=4–6/community or until saturation) and key informant interviews (n=10–12/community or until saturation [28,29] will be conducted among stakeholders and community members to understand local perspectives on stroke, existing treatment options and common options utilized, cost and possible modes of prevention with a major focus on use of the Stroke Information and Surveillance System

Validating and deploying the Stroke Finding System and Stroke Alert System:

As previously stated, the Stroke Information and Surveillance System is composed of the Stroke Alert System through which community members can report strokes and the Stroke Finding System through which healthcare providers/study team can remotely elicit notification of stroke cases from all sources including health facilities via text, SMS, voice calls or internet-based messaging. The Stroke Alert System will be operated using dedicated telephone lines (toll-free hotlines) as well as Voice over Internet Protocol (VoIP) technology. Phonelines will be manned by dedicated and trained operators for 24 hours on all days of the week. The Stroke Finding System will relay information through automated bulk short message service (SMS) [30] and phone calls.

Updating community information and determining accurate de jure populations:

ARISES will also update information on households and conduct a de jure population census at the beginning of the stroke prevalence study period. Trained enumerators will conduct house-to-house visits to update the existing house identification numbers, and ascertain changes to the population database since earlier baseline enumeration and collect required data for stroke surveillance. Household members will be encouraged to store the hotline(s) on all phones available to them. Geo-mapping and tagging of houses & important landmarks will be updated.

Assessing Stroke Prevalence

Operational definition of stroke and process for ascertaining cases:

Stroke will be defined in this study to include spontaneous intracerebral or subarachnoid haemorrhage, or brain infarction, based on pathological, imaging, or other objective evidence of vascular injury in a defined vascular distribution; or clinical evidence of focal vascular brain injury based on symptoms persisting ≥24 hours or until death, with other causes excluded [31]. Transient ischemic attacks will be excluded [32]. CT/MRI brain scan will be performed in all patients to exclude stroke mimics. All cases of stroke (old/new/recurrent) [33] present among adults (aged ≥ 18 years), resident for at least 1 year within the study location will be included [3]. The approach to ensure we find all eligible cases is shown in Figure 2.

Figure 2: Novel Design to Ensure Near Total Case Finding and Ascertainment.

Figure 2:

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Owolabi MO. West Indian Medical Journal 201; 60(4) 412–421.

We will train clinical adjudicators and field enumerators for stroke research using our phenotyping algorithm and ACCESS training tool [18,19]. Regardless of the source of notification, all suspected cases will be confirmed and evaluated using a 3-stage approach by 1) first using the QVSFS tool [34,35] with individuals screened as positive 2) then assessed clinically by an ARISES trained clinical adjudicator 3) Cases will finally be validated and investigated according to Kobayashi et al. and Owolabi et al.,[36,37] a published phenotyping plan using ACCESS. This includes brain scan (CT and MRI), and neurovascular imaging (e.g. CT angiography/MR angiography, Carotid Ultrasound) [18] which are available in designated ARISES facilities within the study vicinity.

Door-to-door surveys:

ARISES will conduct two door-to-door surveys: at the baseline and endline. These surveys, in addition to collecting information on household variables and other outcomes, will elicit information about strokes in the home. Individuals suspected to have strokes will be screened using the QVSFS tool [38]. Individuals with positive screening results will be assessed by a trained clinical adjudicator and investigated accordingly. We will also collect information on home cooking fuels (air quality/pollution), self-reports of chronic diseases (e.g. hypertension), tobacco/alcohol use, physical activity and diet using standard questionnaires.

Identifying stroke patients at orthodox and unorthodox health facilities:

Using the Stroke Finding System, we will canvass orthodox and alternate practice health-workers to elicit notification of stroke patients. Orthodox facilities will include clinics of collaborating general practitioners, nursing homes, physiotherapy clinics, and diagnostic centres from which records including hospital admissions and discharges, emergency room and out-patient clinic registers, requests for brain imaging, carotid ultrasound, electrocardiograms, death certificates and coroners’ records will be searched [39]. Addresses of identified stroke patients will be checked to ascertain if they fall within the DSS stipulated GIS coordinates and individuals identified as resident in the area will be traced and assessed. To capture stroke patients who may receive treatment outside the surveillance areas, we will identify and cover popular treatment options for DSS members as well as major treatment facilities in the vicinity.

Investigation of New / incident Stroke Cases for stroke type, risk factors and outcome:

Stroke cases identified within 10 days of symptom onset will be investigated and followed up at ARISES collaborating institutions according to a standard protocol [18]. Consenting stroke cases identified within this window will be encouraged to transfer to ARISES designated facilities (which are the flagship medical institutions for stroke care in the areas) for evaluation with the consent of their clinical care-providers and caregivers. Individuals who decline to transfer will have the phenotyping protocol instituted at their current location to the greatest extent possible. This evaluation using validated tools and investigations in the protocol, will determine stroke type, stroke severity, presence of stroke risk factors (including socioeconomic and demographic factors; hypertension, diabetes, dyslipidaemia, diet, physical activity, alcohol and tobacco use, infections [e.g., HIV], psychosocial factors and obesity); outcome (including disability and 1-, 3-, 6- and 12-month fatality); and cost (based on our cost methodology) [40]. Blood samples will be collected for future biomarkers, metabolomics and genomic studies and managed using our laboratory information management system [18].

Verifying cause of death by actual and verbal autopsies:

We will review records of death certificates issued by medical practitioners or coroner, registers of deaths maintained in the local government offices, and vital registers kept by orthodox and unorthodox health facilities in the study areas. In those without prior adjudication or autopsy, actual autopsies will be conducted by Ibadan Brain Bank pathologist when feasible based on family willingness and proximity to the pathology equipped SIREN hospitals. Brain autopsies will be conducted using standard techniques as published in the Ibadan Brain bank protocol [40]. Verbal autopsies will be conducted in any suspected stroke death without autopsy, where the individual was not pre-adjudicated as a stroke case, or deaths which have no valid death certificate, autopsy or coroner’s report.

Verbal autopsy interviews will be conducted with the carers or relatives of the deceased within 1 month of death [9,41]. Cause of death will be assigned by applying the International Classification of Diseases (version 10). Two study physicians will independently review findings. If they disagree on cause of death, the form will be sent to a third physician for independent diagnosis. If 2 of the 3 agree, this diagnosis will be taken as the cause of death. If all 3 disagree the cause will be reported as undetermined. Whenever possible, confirmatory evidence of cause of death will be sought.

Integrating the SISS into a sustainable care matrix to improve stroke outcome and wider public health education and surveillance

Utilizing the Stroke Information and Surveillance System to facilitate Stroke Care in the Study Sites:

The network of stroke provider locations, contacts and capacity derived from the baseline survey will be provided to all stakeholders. The surveillance system messaging platforms will be used to mobilize health workers. Periodic messages will be used to reinforce memory of key learning points. Health workers will be encouraged to contact the call centre for stroke-specific enquires and to facilitate transfer by providing advance information and assisting coordination with referral points. A monthly record of activities in this regard will be compiled and reviewed. ARISES will support diagnostic imaging for all stroke cases at its current study sites. This support will be an incentive for prompt transfer and treatment at “appropriate” facilities where treatment will be supported by the health insurance and basic healthcare fund schemes.

Assessing SISS impact on Post-Stroke Outcomes:

1-month stroke outcome will be assessed using the stroke levity scale (SLS) [42] the National Institute of Health Stroke Scale (NIHSS) and the modified Rankin scale (mRS) at baseline Year 1 compared to Year 4. Assessments will be done by clinical adjudicators at presentation and one-month post stroke.

Sustainability through Community Ownership and Capacity building:

To ensure long term utility of the Stroke Information and Surveillance System we will expand community participation to culminate in full community ownership. The feasibility of community ownership will be explored in the initial key interviews with local health department managers. For the first 2 years, biennial meetings with these officials will be conducted to share system working, costs, challenges and opportunities. At the beginning of the third year a week-long series of half day meetings will attempt to produce a transfer plan with each local health department.

Data Management and Statistical Analysis

The REDCap database for the study is domiciled in Ibadan. Built-in checks and quality control measures such as range check and other data validation procedures will be included while designing the REDCap database. A random 10% of entered records will be cross-validated against physical copies at quarterly intervals.

The primary outcome in this study is stroke events. We will also assess stroke type and severity. Independent variables will include demographic, household and socio-economic status. Each case of stroke identified in the community survey will cross checked against surveillance system stroke reports. The proportion of stroke cases identified by the surveillance system in both locations will be compared using Z-test for proportions. The proportion of new stroke cases who presented to stroke care facilities in < 6 hrs at study end will be compared to baseline figures using chi-square test. Further comparison stratified by urban/rural residence and sex will be made using Mantel-Haenzel chi-square test. Regression modelling using GLM will be performed to compare the time to presentation at endline and baseline, with adjustment for covariates and to test if the difference between the two time points varies by sex, urban/rural and socioeconomic groups.

Age-standardisation will be performed using the direct method. Corresponding 95% confidence intervals for all estimates will be calculated based on the assumptions of the Poisson distribution [1,43,44]. Age-adjusted stroke prevalence (with confidence intervals) will be estimated and compared across location, age, gender and socio-economic groups. Logistic regression will be used to estimate the association between the covariates (age, sex, residence, socio-economic status, etc) and stroke occurrence at baseline and end of study. These figures will also be compared with 1982/83 stroke prevalence in the rural location [20].

Assessment of socio-economic status:

We will determine socio economic status using a wealth/asset index [45,46]. A broad range of assets owned by the individuals will be utilised in the computation including human capital (educational level), physical capital (type of housing, ownership of housing, type of cooking fuel, source of lighting [47], type of sanitary convenience) and consumption of durables. These variables will be stratified and weighted to create the index [48] by applying the principal components analysis (PCA) to assign the indicator weights.

Project timeline

ARISES is scheduled to run over 5 years. The first year of the project has been spent securing ethical approval, finalising study tools, setting up the elements of the Stroke Information and Surveillance System and engaging to constitute the community advisory boards and ward committees. The baseline surveys will take place first in the second year alongside full launching of all elements of the surveillance system. The second and final community survey will take place at the end of the 4th study year. The assessment of stroke cases will continue throughout years 2 to 4, alongside community education on stroke and Stroke Information and Surveillance System integration into the community care model for stroke and wider public health issues. The final year will be devoted to project close activity, data cleaning, analysis, transfer of the surveillance system to the community and other sustainability measures.

DISCUSSION

Value of stroke epidemiological surveillance

Despite ongoing efforts towards reducing the burden of stroke in Africa and other regions around the globe [49], as far as we know, ARISES is the first comprehensive attempt at stroke epidemiological surveillance in Africa. The ARISES study incorporates community-based mechanisms to address common methodological flaws of stroke studies. Evidence from the literature indicate common pitfalls of stroke epidemiology include inconsistencies in case definitions, challenges with ascertaining accurate denominator populations, limited use of imaging techniques to confirm stroke events, and difficulties in delineating new from old stroke events [17,18]. The ARISES design addresses these shortcomings, and introduces innovative strategies to enable a comprehensive stroke surveillance system across urban and rural areas in Africa.

Community ownership and long-term sustainability of research project

Active community involvement in public health interventions has been described as a vital strategy for ensuring acceptance of the intervention and its long-term sustainability [50]. In the context of the ARISES study, the sensitization and engagement of community stakeholders such as traditional and religious leaders, as well as health workers will be used to prompt behavioural modification among community members. These community stakeholders would be empowered to serve as focal persons to address misconceptions about the stroke surveillance project among community members, link individuals to stroke care, and promote the uptake of the stroke epidemiological surveillance intervention. Since this research would be driven by the community from the start to its completion, events of rejection of the stroke epidemiological surveillance activities would hopefully be averted. Due to the sense of community-ownership of the project, long-term sustainability of the project would likely be assured.

Benefits of incorporating mobile health into epidemiological surveillance

We expect the Stroke Information and Surveillance System can improve monitoring, diagnosis, and treatment of stroke patients. Moreover, mHealth would improve stroke literacy among stroke patients to improve patient engagement in self-care. Reports from San Francisco revealed that mHealth enhanced the documentation and updating of health records, disease surveillance, and care coordination among community health workers [51]. To enhance efficiency of the Stroke Information and Surveillance System, reminders for appointments would be sent to patients through SMS. Due to its cost-effectiveness, simplicity and adaptability for use in rural settings, the use of SMS in maintaining contact with patients and enhancing notification from health facilities will be promoted. Thus, mHealth will reduce the chances of defaulting from care among stroke patients.

While ARISES proposes significant rigour in establishing stroke epidemiology, the basic idea that existing mobile technology and basic stroke screening tools can be deployed at community level for stroke surveillance is quite simple. Current research shows mobile phone penetrance is high and increasing even in rural African communities. It is therefore conceivable that this system may find wide application despite the wide differences in health system structure and resources within and beyond Africa.

Limitations and Solutions

This research might experience some challenges. Firstly, refusal for referral to ARISES collaborating institutions may occur among some stroke patients. To uphold the principle of autonomy and prevent loss of data on such stroke patients, the phenotyping protocol will be instituted at patient’s current location to the greatest extent possible. Secondly, recruitment of stroke cases in hospitals could result in the exclusion of stroke patients who are either managed in their homes or non-orthodox facilities. To address this challenge, stroke patients will be enrolled from homes, as well as orthodox and non-orthodox health facilities. We will conduct intense community engagement to achieve this.

We anticipate that ARISES could show a path to sustainable community-based surveillance for stroke and other diseases of public health importance in LMICs like Nigeria.

Supplementary Material

suppl mat

Funding Sources

The ARISES R01NS115944 is funded by the National Institutes of Health, USA. Investigators are further supported by NIH grants SIREN (U54HG007479), SIBS Genomics (R01NS107900), SIBS Gen GenR01NS107900-02S1; 352 and H3Africa CVD Supplement 3U24HG009780-03S5

Footnotes

Statements

Statement of Ethics

This study protocol was reviewed and approved by the Institutional Review Board University of Ibadan/University College Hospital Ibadan, approval number UI/EC/19/0629. Written informed consent will be obtained from all study participants and from legally designated caregivers for stroke patients with cognitive or communication impairment.

Conflict of Interest Statements

The authors have no conflicts of interest to declare

Data Availability Statement

This protocol paper does not present any data.

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Supplementary Materials

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Data Availability Statement

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