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
|Condition or disease||Intervention/treatment||Phase|
|Fever||Behavioral: Systematic follow-up Behavioral: Conditional follow-up||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
- 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.
- 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'
- 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'
- 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
- Hospital admission rate [ Time Frame: Day 0-7 ]Rate of hospital admission due to illness up to Day 7 in each arm
- 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
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
|Hawassa, Southern Nations, Nationalities, And Peoples' Region, Ethiopia|
|Principal Investigator:||Karin Kallander, MSc, PhD||Malaria Consortium|