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

NCT ID: NCT04582474

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dengue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dengue module and rapid diagnostic tests

Group Type EXPERIMENTAL

Dengue module and rapid diagnostic tests

Intervention Type OTHER

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

Interventions

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Dengue 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Burkina Faso

OTHER_GOV

Sponsor Role collaborator

Terre des hommes, Burkina Faso & Switzerland

UNKNOWN

Sponsor Role collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brice W Bicaba, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Burkina Faso

Locations

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Centre de Santé et de Promotion Sociale (Sandogo)

Ouagadougou, District Boulmiougou, Burkina Faso

Site Status RECRUITING

Centre de Santé et de Promotion Sociale (Secteur 16)

Ouagadougou, District Boulmiougou, Burkina Faso

Site Status RECRUITING

Countries

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Burkina Faso

Central Contacts

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Brice W Bicaba, MD

Role: CONTACT

+22670264393

Maimouna Sow, MD

Role: CONTACT

+22670264393

Facility Contacts

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Brice W Bicaba, MD

Role: primary

Brice W Bicaba, MD

Role: primary

Other Identifiers

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FE008

Identifier Type: -

Identifier Source: org_study_id

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