Comparison · NCT04290975-b3cc27fd
Task-shifted Arm vs Enhanced Usual Care Arm: Anytime 6-month Seizure-free Interval
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Task-shifted Arm vs Enhanced Usual Care Arm: Anytime 6-month Seizure-free Interval. Trial comparisons, record NCT04290975-b3cc27fd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04290975-b3cc27fd
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.53 | 0.496 | 0.563 | wilson | |
| Risk in group 2 | 0.533 | 0.499 | 0.566 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00314 | -0.0509 | 0.0446 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.994 | 0.908 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.987 | 0.815 | 1.2 | log | |
| Number needed to treat, for one fewer participant with the outcome on Task-shifted Arm than on Enhanced Usual Care Arm | 319 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Task-shifted Arm | In the task-shifted care arm (TSC), all children will be prescribed anti-seizure medication and receive follow-up care from a community health worker (CHW), with a physician consult available to the CHW as needed.~Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs): Children with previously untreated epilepsy, identified via community-based screening and diagnositic evaluations, receive epilepsy care (including anti-seizure medication management) from epilepsy-trained community health workers (CHWs). | 448 | 846 | OG000 |
| Group 2 | Enhanced Usual Care Arm | In the enhanced usual care arm (EUC), all children will be prescribed anti-seizure medication and receive follow-up care from a physician. A CHW collecting standardized data will mirror the intervention arm. In addition, the CHW will enhance the physician care by assisting parents navigate the healthcare system.~Enhanced usual care for epilepsy (EUC): Children with previously untreated epilepsy, identified via community-based screening and diagnostic evaluations, receive epilepsy care by physicians, as routinely done in Nigeria. The usual physician care is enhanced by community health workers (CHWs), who do not participate in the child's epilepsy care, but who help families navigate the healthcare system. | 440 | 826 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Anytime 6-month Seizure-free Interval
- Description
6-month seizure-free intervals as determined by evaluations by physicians with expertise in epilepsy, blinded as to the arm of the study, at 6 months, 12 months, 18 months and 24 months after enrollment. These blinded physicians with expertise in epilepsy will record seizure frequency (including seizure-freedom) on standardized case report forms, facilitated by blinded physician review of daily seizure logs maintained by parents/guardians that will indicate the specific dates and durations of all recorded seizures.
- Time frame
- Baseline to 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04290975?tab=results
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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