Trial · NCT04290975
Bridging the Childhood Epilepsy Treatment Gap in Africa
NCT04290975, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2026-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bridging the Childhood Epilepsy Treatment Gap in Africa. Trials, record NCT04290975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04290975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bridging the Childhood Epilepsy Treatment Gap in Africa
- NCT number
- NCT04290975
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,672 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Epilepsy
- Interventions
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
- First posted
- 2020-03-02
- Last updated
- 2026-02-20
- Results first posted
- 2026-02-20
- Limitations and caveats
This cluster randomized clinical trial (cRCT) is the first large cRCT of task-shifting epilepsy care to community health workers (CHWs) to treat people with untreated epilepsy in low-and-middle income countries of Africa. The study participants are representative of the population of children with previously untreated epilepsy in Nigeria. Because the study was performed under real-world conditions of northern Nigeria, MRI and EEG were not available for most of the study subjects.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment | Outcome measured 18 months to 24 months after enrollment | Percentage of children in each arm of the study who were seizure-free for 6 months, or longer, measured specifically at 24 months after enrollment. Physicians with expertise in epilepsy, blinded as to study arm, utilized review of seizure diaries maintained by parents plus medical history, to determine whether each child had been seizure free for six months, or longer, 24 months after enrollment in the cluster RCT. |
| 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 | 75% or greater reduction in seizure frequency (including seizure freedom) for 6 months or longer was determined by the blinded physician at the 24-month follow-up visit, compared to seizure frequency reported at time of enrollment. Outcome variance estimates were adjusted for cluster correlation. At 24 months this secondary outcome is captured for 1488 of 1672 randomized, eligible patients. 101/826 (12.2%) EUC patients and 83/846 (9.8%) TSC patients are missing the secondary outcome at 24 months. |
| 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 | 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. |
| Secondary | Diagnostic Accuracy | Diagnostic accuracy measured at 1 month after enrollment. | Diagnostic accuracy was determined based upon diagnosis of epilepsy (or"not 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. |
| Secondary | Mortality | Deaths measured for 25 months after enrollment. | Differences in mortality between study arms that cannot be explained by potential differences in disease severity |
| Secondary | Number of Children Who Experienced Status Epilepticus | Baseline to 24 months after enrollment | Difference in the number of children who experienced status epilepticus among children in both arms of the study, as measured by questions in standardized case report forms completed by physicians with expertise in epilepsy, who are blinded as to the arm of the study. The blinded physicians will review a daily seizure log which indicates estimated seizure duration for each seizure, maintained by the parent/guardian, to facilitate the blinded physician evaluation. |
| Secondary | Morbidity | Morbidity outcomes measured for 24 months after enrollment. | Differences in morbidity, including neurodevelopmental morbidity (e.g., cerebral palsy), associated with epilepsy between study arms that emerged during the cRCT. Evaluations for CP were conducted during the 24-month follow-up period. Evaluations for wasting and for stunting were performed during follow-up visits of the 24-month study. |
| Secondary | Number of Children for Whom an EEG Was Ordered | Baseline to 24 months after enrollment | Differences by study arm in cumulative number of children for whom EEGs were ordered |
| Secondary | Task-shifted Protocol Adherence | Baseline to 24 months after enrollment. | Reported protocol violations among the study subjects receiving task-shifted epilepsy care from community health workers. |
| Secondary | Anytime 6-month Seizure-free Interval | Baseline to 24 months after enrollment. | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment | Task-shifted Epilepsy Care Arm (TSC) | 371 | Participants | ||
| Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment | Enhanced Usual Epilepsy Care Arm (EUC) | 299 | Participants | ||
| 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | Task-shifted Epilepsy Care Arm (TSC) | 636 | Participants | ||
| 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | Enhanced Usual Epilepsy Care Arm (EUC) | 531 | Participants | ||
| Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug | Task-shifted Epilepsy Care Arm (TSC) | 306 | Participants | ||
| Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug | Enhanced Usual Epilepsy Care Arm (EUC) | 149 | Participants | ||
| Diagnostic Accuracy | Task-shifted Epilepsy Care Arm (TSC) | 846 | Participants | ||
| Diagnostic Accuracy | Enhanced Usual Epilepsy Care Arm (EUC) | 826 | Participants | ||
| Mortality | Task-shifted Epilepsy Care Arm (TSC) | 50 | Participants | ||
| Mortality | Enhanced Usual Epilepsy Care Arm (EUC) | 54 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Task-shifted Epilepsy Care Arm (TSC) | 846 | 30 |
| Overall Study | STARTED | Enhanced Usual Epilepsy Care Arm (EUC) | 826 | 30 |
| Overall Study | COMPLETED | Task-shifted Epilepsy Care Arm (TSC) | 763 | 30 |
| Overall Study | COMPLETED | Enhanced Usual Epilepsy Care Arm (EUC) | 724 | 30 |
| Overall Study | NOT COMPLETED | Task-shifted Epilepsy Care Arm (TSC) | 83 | 0 |
| Overall Study | NOT COMPLETED | Enhanced Usual Epilepsy Care Arm (EUC) | 102 | 0 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Clinic evaluation for febrile illness | Infections and infestations | Task-shifted Epilepsy Care Arm (TSC) | 4 | 846 | 4 |
| other | Clinic evaluation for febrile illness | Infections and infestations | Enhanced Usual Epilepsy Care Arm (EUC) | 0 | 826 | 0 |
| other | rash | Skin and subcutaneous tissue disorders | Task-shifted Epilepsy Care Arm (TSC) | 1 | 846 | 1 |
| other | rash | Skin and subcutaneous tissue disorders | Enhanced Usual Epilepsy Care Arm (EUC) | 1 | 826 | 1 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Task-shifted Epilepsy Care Arm (TSC) | 1 | 846 | 1 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Enhanced Usual Epilepsy Care Arm (EUC) | 1 | 826 | 1 |
| other | Hydropneumothorax of unknown likely infectious etiology | Infections and infestations | Task-shifted Epilepsy Care Arm (TSC) | 1 | 846 | 1 |
| other | Hydropneumothorax of unknown likely infectious etiology | Infections and infestations | Enhanced Usual Epilepsy Care Arm (EUC) | 0 | 826 | 0 |
| other | Clinic visit for sudden increase in seizure frequency | Nervous system disorders | Task-shifted Epilepsy Care Arm (TSC) | 0 | 846 | 0 |
| other | Clinic visit for sudden increase in seizure frequency | Nervous system disorders | Enhanced Usual Epilepsy Care Arm (EUC) | 2 | 826 | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Task-shifted Epilepsy Care Arm (TSC) | 50 | 846 |
| Total, all-cause mortality | Enhanced Usual Epilepsy Care Arm (EUC) | 54 | 826 |
| Total, other adverse events | Task-shifted Epilepsy Care Arm (TSC) | 7 | 846 |
| Total, other adverse events | Enhanced Usual Epilepsy Care Arm (EUC) | 7 | 826 |
| Total, serious adverse events | Task-shifted Epilepsy Care Arm (TSC) | 33 | 846 |
| Total, serious adverse events | Enhanced Usual Epilepsy Care Arm (EUC) | 25 | 826 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Mortality | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Number of Children for Whom an EEG Was Ordered | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Diagnostic Accuracy | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): Number of Children Who Experienced Status Epilepticus | Trial comparisons |
| Task-shifted Arm vs Enhanced Usual Care Arm: Anytime 6-month Seizure-free Interval | Trial comparisons |
| 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 |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): deaths from any cause | Trial comparisons |
| Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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