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Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever (TRAction)

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ClinicalTrials.gov Identifier: NCT02926625
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Karolinska Institutet
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Malaria Consortium

Brief Summary:
Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World Health Organization (WHO) recommends that all children be reassessed in 3 days. It is hypothesized that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations, Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which no cause of fever can be identified and where danger signs are absent.

Condition or disease Intervention/treatment Phase
Fever Behavioral: Systematic follow-up Behavioral: Conditional follow-up Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever at the Community Level: A Study to be Conducted in Ethiopia
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Malaria

Arm Intervention/treatment
Active Comparator: Conditional follow-up
Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, ie. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.
Behavioral: Conditional follow-up
Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, i.e. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.
Other Name: control arm

Experimental: Systematic follow-up arm
Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should come back for a systematic follow-up visit after 2 days, even if the child has recovered.
Behavioral: Systematic follow-up

Febrile children without a diagnosable illness and without danger signs do not need to return to the HEW unless they are still sick, as over 90% of fevers resolve by themselves.

HEW advice and procedures

  • Children with unclassified fever should come back for re-assessment after 2 days only if the child still has fever or is sick
  • Children who are getting worse should come back immediately or at any time for a re-assessment
  • All children who come back for re-assessment, regardless of when they come back, should have a full assessment of their condition again.
  • HEW should fill out a loose child assessment form
  • If child still has fever and a negative rapid diagnostic test for malaria (mRDT), the HEW should refer the child to the nearest health centre.




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: Day 7 ]
    Proportion of children with non-severe febrile illness who, after initial evaluation by a HEW using iCCM algorithm, are not treated for malaria, pneumonia, or diarrhea and who subsequently decline clinically (defined as death, hospitalization, or the development of one or more danger signs).


Secondary Outcome Measures :
  1. Illness classification among children with unresolved illness [ Time Frame: Day 7 ]
    Descriptive statistics of the symptoms and signs in those children with unresolved illness at Day 7 in each arm, as identified by clinically trained research assistants.

  2. Proportion of caregivers who present to HEWs for the follow-up visit on Day 3 [ Time Frame: Day 3 ]
    Proportion of caregivers who present for the follow-up visit on Day 3 in the 'systematic visit arm'

  3. Proportion of caregivers who spontaneously re-present to HEWs [ Time Frame: Day 0-7 ]
    Proportion of caregivers who spontaneously re-present to HEWs for persistence or worsening of symptoms in the 'conditional visit arm'

  4. Secondary treatment [ Time Frame: Day 0-7 ]
    Proportion of children receiving secondary treatment (antimicrobial medicines prescribed during visits to any providers after initial presentation to HEWs) in each arm

  5. Hospital admission rate [ Time Frame: Day 0-7 ]
    Rate of hospital admission due to illness up to Day 7 in each arm


Other Outcome Measures:
  1. Caregiver and HEW acceptability of systematic and conditional follow-up [ Time Frame: Day 0-28 ]
    The acceptability of caregivers and HEW towards the two types of follow-up recommendations



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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-severe febrile illness that is classified by HEW as unspecific fever

Exclusion Criteria:

  • Malaria, pneumonia, diarrhoea diagnosis
  • Symptoms requiring referral

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926625


Locations
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Ethiopia
Ethiopia
Hawassa, Southern Nations, Nationalities, And Peoples' Region, Ethiopia
Sponsors and Collaborators
Malaria Consortium
Karolinska Institutet
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Karin Kallander, MSc, PhD Malaria Consortium
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Malaria Consortium
ClinicalTrials.gov Identifier: NCT02926625    
Other Study ID Numbers: FY15-G04-6990
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Malaria Consortium:
Unspecific fever
Ethiopia
iCCM
CHW
HEW
Additional relevant MeSH terms:
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Fever
Body Temperature Changes