Comparison · NCT04290975-53d679aa
Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Diagnostic Accuracy
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): Diagnostic Accuracy. Trial comparisons, record NCT04290975-53d679aa. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04290975-53d679aa
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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 | 0.962 | 0.948 | 0.973 | wilson | |
| Risk in group 2 | 0.933 | 0.915 | 0.948 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0291 | 0.00837 | 0.0504 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 1.01 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 1.83 | 1.18 | 2.83 | log | |
| 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) | 34.3 | 19.8 | 119 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Task-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. | 846 | 879 | OG000 |
| Group 2 | Enhanced 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. | 826 | 885 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Diagnostic Accuracy
- Description
Diagnostic accuracy was determined based upon diagnosis of epilepsy (ornot epilepsy) by physicians with expertise in epilepsy, blinded as to study arm, or blinded physicians. Non-inferiority of TSC arm diagnostic accuracy was declared if the lower limit for the ratio of the odds of being accurately diagnosed in the intervention (TSC) versus standard-of-care enhanced by community health workers (CHWs) helping parents navigate the healthcare system is below the odds ratio implied by a 10% absolute difference between study arms.
- Time frame
- Diagnostic accuracy measured at 1 month after enrollment.
- Population
Children who screened positive for epilepsy were assigned to the participating primary healthcare center (PHC) closest to their home address, either a PHC randomly assigned to the task-shifted care (TSC) arm or the enhanced usual physician epilepsy care (EUC) arm. The TSC study subjects had diagnostic evaluations by epilepsy-trained community health workers (CHWs), while the EUC study subjects were referred directly to physicians for diagnostic evaluations.
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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