Trial · NCT04290975
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment | Outcome measured 18 months to 24 months after enrollment | Enrolled children at 24-month following enrollment follow-up visit with blinded physicians. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | Outcome measured 18 months to 24 months after enrollment | Outcome variance estimates adjusted for cluster correlation. At 24 months the secondary outcome is captured for 1488 of 1672 randomized, eligible study subjects. 101/826 (12.2%) EUC patients and 83/846 (9.8%) TSC patients are missing this secondary outcome at 24 months, as blinded physicians in some instances were unable to determine the percentage decrease in seizure frequency. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug | Outcome measured from prescription of the first anti-seizure medication during 24 months after enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Diagnostic Accuracy | Diagnostic accuracy measured at 1 month after enrollment. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality | Deaths measured for 25 months after enrollment. | This analysis was performed on the Epilepsy Outcomes Population or those diagnosed with epilepsy who were enrolled in the clinical trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Children Who Experienced Status Epilepticus | Baseline to 24 months after enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Morbidity | Morbidity outcomes measured for 24 months after enrollment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Children for Whom an EEG Was Ordered | Baseline to 24 months after enrollment | This analysis was performed upon the Diagnostic Accuracy Population, among those children who screened positive for epilepsy by arm of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Task-shifted Protocol Adherence | Baseline to 24 months after enrollment. | Task-shifted protocol violations by CHWs when providing epilepsy care for the 846 children assigned to TSC in 30 clusters. | # protocol violations by CHWs | NUMBER |
| SECONDARY | Anytime 6-month Seizure-free Interval | Baseline to 24 months after enrollment. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Seizure Disability Weights | Outcome measured for 24 months after enrollment. | The seizure disability weights were determined for the epilepsy outcomes population of the BRIDGE cluster randomized clinical trial, with 846 children enrolled across 30 clusters in the Task-Shifted Epilepsy Care (TSC) arm, and 826 children enrolled across 30 clusters in the Enhanced Usual Epilepsy Care (EUC) arm. | units on a scale, 0 to 1. | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04290975/outcomes