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

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ClinicalTrials.gov Identifier: NCT04582474
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
Ministry of Health, Burkina Faso
Terre des hommes, Burkina Faso & Switzerland
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Tracking Information
First Submitted Date  ICMJE September 8, 2020
First Posted Date  ICMJE October 9, 2020
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE September 10, 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals [ Time Frame: 4 months ]
    This 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 module [ Time Frame: 4 months ]
    This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system [ Time Frame: 4 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. [ Time Frame: 4 months ]
  • Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed. [ Time Frame: 4 months ]
  • Positive predictive value of dengue rapid diagnostic test [ Time Frame: 4 months ]
    Polymerase chain reaction results will be used as the reference test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
Official Title  ICMJE Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Dengue
Intervention  ICMJE Other: 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
Study Arms  ICMJE Experimental: Dengue module and rapid diagnostic tests
Intervention: Other: Dengue module and rapid diagnostic tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2020)
335
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brice W Bicaba, MD +22670264393 bicaba_brico@yahoo.fr
Contact: Maimouna Sow, MD +22670264393 beldoso@yahoo.fr
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04582474
Other Study ID Numbers  ICMJE FE008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Foundation for Innovative New Diagnostics, Switzerland
Study Sponsor  ICMJE Foundation for Innovative New Diagnostics, Switzerland
Collaborators  ICMJE
  • Ministry of Health, Burkina Faso
  • Terre des hommes, Burkina Faso & Switzerland
Investigators  ICMJE
Principal Investigator: Brice W Bicaba, MD Ministry of Health, Burkina Faso
PRS Account Foundation for Innovative New Diagnostics, Switzerland
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP