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Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso

Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04582474
Enrollment
335
Registered
2020-10-09
Start date
2020-09-10
Completion date
2020-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue

Keywords

Non-malarial fevers, Clinical decision support tools, Rapid diagnostic test

Brief summary

The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response. The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive. An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease. In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.

Interventions

OTHERDengue module and rapid diagnostic tests

Digital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines

Sponsors

Foundation for Innovative New Diagnostics, Switzerland
Lead SponsorOTHER
Ministry of Health, Burkina Faso
CollaboratorOTHER_GOV
Terre des hommes, Burkina Faso & Switzerland
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Older than 6 month * Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT * Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure

Exclusion criteria

* Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw * Patients with severe disease requiring urgent care

Design outcomes

Primary

MeasureTime frameDescription
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals4 monthsThis outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
Evaluation of the adherence to the different steps of the module4 monthsThis outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.

Secondary

MeasureTime frameDescription
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system4 months
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.4 months
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.4 months
Positive predictive value of dengue rapid diagnostic test4 monthsPolymerase chain reaction results will be used as the reference test.

Countries

Burkina Faso

Contacts

PRINCIPAL_INVESTIGATORBrice W Bicaba, MD

Ministry of Health, Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026