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Comparison · NCT04290975-c5672030

Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug. Trial comparisons, record NCT04290975-c5672030. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04290975-c5672030

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6270.5830.669wilson
Risk in group 20.3390.2960.384wilson
Risk difference, group 1 minus group 20.2880.2250.348newcombe hybrid score
Risk ratio, group 1 over group 21.851.62.15log
Odds ratio, group 1 over group 23.282.514.3log
Number needed to treat, for one more participant with the outcome on Task-shifted Epilepsy Care Arm (TSC) than on Enhanced Usual Epilepsy Care Arm (EUC)3.472.874.44from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Task-shifted Epilepsy Care Arm (TSC)
In the task-shifted arm composed of thirty clusters, each cluster being a primary healthcare center (PHC) serving a local community, all children who screened positive for untreated epilepsy underwent a diagnostic evaluation by an epilepsy-trained community health worker (CHW), supervised remotely by a physician with epilepsy expertise. Children who were diagnosed with untreated epilepsy after screening positive for epilepsy were prescribed anti-seizure medication (ASM) by the epilepsy-trained CHW according to a task-shifted protocol, and received follow-up care from an epilepsy-trained CHW, according to the specified task-shifted epilepsy protocol. These epilepsy-trained CHWs were supervised remotely by physicians with expertise in epilepsy, and were able to consult physicians with questions on an as-needed basis.
306488OG000
Group 2Enhanced Usual Epilepsy Care Arm (EUC)
In the enhanced usual care arm composed of thirty clusters, each cluster being a primary healthcare center (PHC) serving a local community, all children who screened positive for epilepsy were referred to a physician according to standard medical practice at the PHC. The diagnostic evaluation was performed by the physician in the community. Children diagnosed by the physician as having epilepsy were prescribed anti-seizure medication (ASM) and received follow-up care from a physician.~In addition to the usual epilepsy care provided by the physician, each child in the EUC arm was followed by an epilepsy-trained CHW, who followed the child's progress, helped the family navigate the healthcare system (including finding a physician). The usual physician care of epilepsy was enhanced by the support of a CHW, but epilepsy diagnosis and treatment was provided by a physician, not by the epilepsy-trained CHW.
149440OG001

Outcome

Type
SECONDARY
Title
Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug
Description
Percentage of children seizure-free for 6 months or longer in response to the first anti-epileptic drug prescribed, as measured by questions in standardized case report forms completed by physicians with epilepsy expertise, blinded as to the arm of the study. The blinded physicians will review a daily seizure log which indicates the occurrence and duration of each seizure, maintained by the parent/guardian, to facilitate the blinded physician evaluation.
Time frame
Outcome measured from prescription of the first anti-seizure medication during 24 months after enrollment
Population

Source ClinicalTrials.gov

Trial

Title
Bridging the Childhood Epilepsy Treatment Gap in Africa
NCT number
NCT04290975
Phases
NA
Conditions
Epilepsy
Interventions
Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
Lead sponsor
Vanderbilt University Medical Center
Results first posted
2026-02-20

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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