Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PACTR202003864779691 | Registry Identifier | Pan African Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aminu Kano Teaching Hospital | OTHER |
| Ahmadu Bello University Teaching Hospital | OTHER |
| Federal Neuro-Psychiatric Hospital, Kaduna | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.
Epilepsy is the most common severe neurological disorder among children. Most children with epilepsy, if treated, can live normal lives. Yet among the world's children living with epilepsy, about 80% of whom reside in low- and middle-income countries (LMICs), about half do not receive treatment; this is described as "the childhood epilepsy treatment gap." Among the LMICs of Africa, the childhood epilepsy treatment gap is about 67%-90% - unchanged for over twenty years. Although the World Health Organization (WHO) and other health agencies recommend that the epilepsy treatment gap be bridged by task shifting epilepsy care to community health extension workers (CHWs) in primary care settings, this recommendation has not been implemented on a large scale. This failure to scale up task shifting in epilepsy care is due to (a) inadequate evidence of efficacy of task-shifted epilepsy care, (b) a lack of methods and tools for implementing epilepsy task shifting, (c) inadequate understanding of task-shifted epilepsy care barriers, and (d) a lack of cost-effectiveness data for health policymakers. CHWs providing task-shifted epilepsy care must identify children with epilepsy, disadvantaged by stigma and unknown to the healthcare system, who are without access to neurologists or electroencephalograms (EEGs). An epilepsy screening tool in the local language (e.g., Hausa) is therefore essential for epilepsy diagnosis, seizure type classification, and medical management. Hausa, the most commonly spoken language in west Africa, with over 120 million Hausa speakers, is used in daily life, commerce, and education; our proposed study will be conducted in three major cities in Hausa-speaking Africa.
Funded by an R21 grant (R21TW010899) in preparation for this cluster-randomized clinical trial (cRCT), we developed and piloted in Kano, Nigeria (a) a scalable epilepsy training program for CHWs, (b) an epilepsy community education program in Hausa to facilitate screening, diagnosis and treatment; and (c) an epilepsy data management system. We also (d) validated an epilepsy screening, diagnosis, and seizure classification tool in Hausa, (e) demonstrated feasibility of screening and enrolling children in a cRCT of task-shifted epilepsy care, and (f) piloted a task-shifted epilepsy diagnosis and management protocol. We will now conduct the first cRCT of task-shifted childhood epilepsy care in Africa with the following specific aims:
Conduct a non-inferiority cRCT of a task-shifted childhood epilepsy care protocol compared to enhanced usual care (EUC) in three Hausa-speaking cities in northern Nigeria. We will enroll a maximum of 1800 children (age 6 mo, <18 yrs) with epilepsy across 60 randomly selected primary healthcare centers (PHCs) in Kano (30 PHCs), Kaduna (16 PHCs) and Zaria (14 PHCs). PHCs will be randomly assigned to intervention (task-shifted to CHWS childhood epilepsy care; 30 PHCs) or EUC (referral to a physician for epilepsy management; 30 PHCs). Primary outcome: we hypothesize that the proportion of children seizure-free for ≥ 6 months at 24 months follow-up (primary outcome) will be similar in the intervention and EUC arms. Secondary outcomes at 24 months include (a) percent seizure reduction from baseline, (b) time to next seizure after 3 months seizure-free, and (c) accuracy of epilepsy diagnosis and seizure type classification by CHWs compared to assessments by physician epilepsy specialists, blinded to the randomization arm.
Additional studies of (1) socio-behavioral and implementation outcomes of implementing task-shifted epilepsy care among providers, parents/guardians and patients in the cRCT, and (2) the cost-effectiveness of the task-shifted epilepsy care intervention will performed/completed after completion of the cRCT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Task-shifted arm | Experimental | 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. |
|
| Enhanced usual care arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs) | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Seizure-free for 6 Months, or Longer, Measured at 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. | Outcome measured 18 months to 24 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Disability Weights | Seizure disability weights were determined for all enrolled children in each arm of the cluster randomized clinical trial (cRCT), beginning with information from enrollment, collected at each study visit, for the total duration of the study subject's enrollment in the study. For each follow-up visit, we computed average monthly seizure frequency over the reported study intervals. We time-weighted the disability weights across the 24-month study horizon for each enrolled child. The seizure disability weights are measured on a 0-1 scale, with "0" representing perfect health and "1" representing death. The seizure disability weight represents the severity of a non-fatal health state, with the lower score being more favorable. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edwin Trevathan, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Aminu Taura, MBBS | Aminu Kano Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Neuro-Psychiatric Hospital | Kaduna | Nigeria | ||||
| Aminu Kano Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23449175 | Background | de Boer HM, Moshe SL, Korey SR, Purpura DP. ILAE/IBE/WHO Global Campaign Against Epilepsy: a partnership that works. Curr Opin Neurol. 2013 Apr;26(2):219-25. doi: 10.1097/WCO.0b013e32835f2037. | |
| 18280210 | Background | de Boer HM, Mula M, Sander JW. The global burden and stigma of epilepsy. Epilepsy Behav. 2008 May;12(4):540-6. doi: 10.1016/j.yebeh.2007.12.019. Epub 2008 Feb 14. |
Not provided
Not provided
The principal investigators and research personnel will share deidentified data from the study in multiple modes:
A standard analysis file will be created for use in the analysis of the trial, and for manuscripts and reports. At the end of the trial, the analysis file will be circulated to each internal investigator. If an internal trial investigator requests a special file be created for him/her, a complete proposal must be submitted as detailed below. The contents/variables of the standard analysis file will be posted in the members-only section of the trial website. The internal analysis file will include data from screening and baseline forms, follow-up visit forms with CHWs, seizure diaries, medication administration diaries, neurological exams, laboratory (clinical laboratory, EEG, brain imaging) forms, and outcomes. A section for potential external investigators will also be created on the trial website, which will list the variables from the case report forms. In general, external investigators will be limited to variables from this list.
Both internal and external investigators are required to submit a proposal requesting a dataset from the trial, describing the following elements in detail:
Not provided
Children who screened positive for epilepsy were assigned to a study arm (TSC or EUC) based upon their home address, and whether the participating PHC (cluster) closest to their home was randomly assigned to TSC or EUC. Among children with positive epilepsy screens, those who lived in a TSC area were referred to the PHC for diagnosis and treatment by an epilepsy-trained CHW, who followed the task-shifted protocol; those in EUC areas were referred to physicians for diagnosis and treatment.
June 15, 2020 - Sept. 9, 2021, mothers of 41,623 children in the study area consented to their children being screened for epilepsy. Of 1852 children who screened positive for epilepsy, 1764 children (TSC=879 in 30 clusters; EUC=885 in 30 clusters) were initially diagnosed with epilepsy; 1672 children with a final diagnosis of epilepsy (TSC=846 in 30 clusters; EUC=826 in 30 clusters) enrolled in the epilepsy outcomes cluster RCT. Neither mothers nor CHWs were considered enrolled in the RCT.
| ID | Title | Description |
|---|---|---|
| FG000 | Task-shifted Epilepsy Care Arm (TSC) | In the task-shifted arm composed of thirty (30) 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. |
| FG001 | Enhanced Usual Epilepsy Care Arm (EUC) | In the enhanced usual care arm composed of thirty (30) 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Among 846 participants enrolled in the TSC arm all were children. Among 826 participants enrolled in the EUC arm all were children. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Seizure-free for 6 Months, or Longer, Measured at 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. | Enrolled children at 24-month following enrollment follow-up visit with blinded physicians. | Posted | Count of Participants | Participants | Outcome measured 18 months to 24 months after enrollment |
|
Adverse event data were collection on study subjects from the time of enrollment until 1 month after completion of the 24-month follow-up visit for the cluster randomized clinical trial.
Standard NIH definitions for adverse events and classifying adverse events was taken from common data elements, incorporated into the study protocol and training of all study staff. The recording of adverse events was recorded in a systematic manner using REDCap-based case report forms at all scheduled study visits. Parents of study subjects were instructed to call their study community health worker to report adverse events between study visits.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | All hospitalizations were considered serious adverse events. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinic evaluation for febrile illness | Infections and infestations | Systematic Assessment | Evaluation for febrile illness in medical facility (hospital or clinic), but not severe enough to require hospitalization. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwin Trevathan, MD, MPH, Amos Christie Chair in Global Health, Professor of Pediatrics & Neurology | Vanderbilt Institute for Global Health, Vanderbilt University Medical Center | 6153229374 | edwin.trevathan@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2021 | Jul 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2023 | Jul 6, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2021 | Jul 7, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
This is a cluster randomized clinical trial (cRCT) in which 60 primarily healthcare centers (PHCs), each serving a defined community, are designated as the 60 clusters. The clusters were randomly selected from 398 eligible PHCs in three major cities in the Hausa-speaking areas of northern Nigeria -30 of about 167 PHCs in Kano, 15 of 123 PHCs in Kaduna, and 15 of about 108 PHCs in Zaria. Half of the overall PHCs were randomly assigned to the task-shifted childhood epilepsy care (TSC) arm of the cRCT, in which childhood epilepsy treatment and follow-up care is provided by a CHW. The other half were assigned to "enhanced usual care" (EUC) in which the care is provided by a physician and a CHW serves to record events and collect other standardized data. Children with previously untreated epilepsy were enrolled and assigned to PHCs based upon the participating PHC closest to their home. CHWs and mothers were not considered enrolled in the study.
Not provided
Not provided
Four epilepsy-trained physicians served as blinded physicians for the study, and evaluated every study subjects in both arms at 1, 6, 12, 18, and 24 months after enrollment. These blinded physicians had no other role in the cRCT other than to serve as the gold standard for the diagnosis of epilepsy, to determine study subjects' seizure frequency, potential anti-seizure medication (ASM)-related adverse events and monitored each child's exam and development. Blinded physicians entered clinical data into case report forms on their study-dedicated android tablet computers, with data uploaded to the study data office and the data coordinating center. Parents/guardians, study staff and co-investigators were instructed to not disclose the study arm of study subjects with blinded physicians. Blinded physicians were not included in study meetings, did not have access to study offices or study data, and met separately with study principal investigators to address any study related issues.
|
|
| Enhanced usual care for epilepsy (EUC) | Other | 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. |
|
|
| Outcome measured 18 months to 24 months after enrollment |
| Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug | 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. | Outcome measured from prescription of the first anti-seizure medication during 24 months after enrollment |
| Diagnostic Accuracy | 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. | Diagnostic accuracy measured at 1 month after enrollment. |
| Mortality | Differences in mortality between study arms that cannot be explained by potential differences in disease severity | Deaths measured for 25 months after enrollment. |
| Number of Children Who Experienced Status Epilepticus | 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. | Baseline to 24 months after enrollment |
| Morbidity | 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. | Morbidity outcomes measured for 24 months after enrollment. |
| Number of Children for Whom an EEG Was Ordered | Differences by study arm in cumulative number of children for whom EEGs were ordered | Baseline to 24 months after enrollment |
| Task-shifted Protocol Adherence | Reported protocol violations among the study subjects receiving task-shifted epilepsy care from community health workers. | Baseline to 24 months after enrollment. |
| Anytime 6-month Seizure-free Interval | 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. | Baseline to 24 months after enrollment. |
| Outcome measured for 24 months after enrollment. |
| Kano |
| Nigeria |
| Ahmadu Bello University Teaching Hospital | Zaria | Nigeria |
| 12781390 | Background | Diop AG, de Boer HM, Mandlhate C, Prilipko L, Meinardi H. The global campaign against epilepsy in Africa. Acta Trop. 2003 Jun;87(1):149-59. doi: 10.1016/s0001-706x(03)00038-x. |
| 15694563 | Background | Ndoye NF, Sow AD, Diop AG, Sessouma B, Sene-Diouf F, Boissy L, Wone I, Toure K, Ndiaye M, Ndiaye P, de Boer H, Engel J, Mandlhate C, Meinardi H, Prilipko L, Sander JW. Prevalence of epilepsy its treatment gap and knowledge, attitude and practice of its population in sub-urban Senegal an ILAE/IBE/WHO study. Seizure. 2005 Mar;14(2):106-11. doi: 10.1016/j.seizure.2004.11.003. |
| 22770914 | Background | Mbuba CK, Ngugi AK, Fegan G, Ibinda F, Muchohi SN, Nyundo C, Odhiambo R, Edwards T, Odermatt P, Carter JA, Newton CR. Risk factors associated with the epilepsy treatment gap in Kilifi, Kenya: a cross-sectional study. Lancet Neurol. 2012 Aug;11(8):688-96. doi: 10.1016/S1474-4422(12)70155-2. Epub 2012 Jul 6. |
| 23021288 | Background | Newton CR, Garcia HH. Epilepsy in poor regions of the world. Lancet. 2012 Sep 29;380(9848):1193-201. doi: 10.1016/S0140-6736(12)61381-6. |
| 23539548 | Background | Wilmshurst JM, Cross JH, Newton C, Kakooza AM, Wammanda RD, Mallewa M, Samia P, Venter A, Hirtz D, Chugani H. Children with epilepsy in Africa: recommendations from the International Child Neurology Association/African Child Neurology Association Workshop. J Child Neurol. 2013 May;28(5):633-44. doi: 10.1177/0883073813482974. Epub 2013 Mar 28. |
| 24655403 | Background | Wilmshurst JM, Kakooza-Mwesige A, Newton CR. The challenges of managing children with epilepsy in Africa. Semin Pediatr Neurol. 2014 Mar;21(1):36-41. doi: 10.1016/j.spen.2014.01.005. Epub 2014 Jan 14. |
| 19823570 | Background | Mbuba CK, Newton CR. Packages of care for epilepsy in low- and middle-income countries. PLoS Med. 2009 Oct;6(10):e1000162. doi: 10.1371/journal.pmed.1000162. Epub 2009 Oct 13. |
| 18557778 | Background | Mbuba CK, Ngugi AK, Newton CR, Carter JA. The epilepsy treatment gap in developing countries: a systematic review of the magnitude, causes, and intervention strategies. Epilepsia. 2008 Sep;49(9):1491-503. doi: 10.1111/j.1528-1167.2008.01693.x. Epub 2008 Jun 13. |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Baseline Seizures per month | At baseline enrollment the mean number of seizures per month | Mean | Standard Deviation | Number of Seizures per Month |
|
| OG001 | 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. |
|
|
|
| Secondary | 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit | 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. | 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. | Posted | Count of Participants | Participants | Outcome measured 18 months to 24 months after enrollment |
|
|
|
| Secondary | Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug | 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. | Posted | Count of Participants | Participants | Outcome measured from prescription of the first anti-seizure medication during 24 months after enrollment |
|
|
|
| Secondary | Diagnostic Accuracy | 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. | 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. | Posted | Count of Participants | Participants | Diagnostic accuracy measured at 1 month after enrollment. |
|
|
|
|
| Secondary | Mortality | Differences in mortality between study arms that cannot be explained by potential differences in disease severity | This analysis was performed on the "Epilepsy Outcomes Population" or those diagnosed with epilepsy who were enrolled in the clinical trial. | Posted | Count of Participants | Participants | Deaths measured for 25 months after enrollment. |
|
|
|
| Secondary | Number of Children Who Experienced Status Epilepticus | 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. | Posted | Count of Participants | Participants | Baseline to 24 months after enrollment |
|
|
|
| Secondary | Morbidity | 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. | Posted | Count of Participants | Participants | Morbidity outcomes measured for 24 months after enrollment. |
|
|
|
| Secondary | Number of Children for Whom an EEG Was Ordered | Differences by study arm in cumulative number of children for whom EEGs were ordered | This analysis was performed upon the "Diagnostic Accuracy Population", among those children who screened positive for epilepsy by arm of the study. | Posted | Count of Participants | Participants | Baseline to 24 months after enrollment |
|
|
|
| Secondary | Task-shifted Protocol Adherence | Reported protocol violations among the study subjects receiving task-shifted epilepsy care from community health workers. | Task-shifted protocol violations by CHWs when providing epilepsy care for the 846 children assigned to TSC in 30 clusters. | Posted | Number | # protocol violations by CHWs | Baseline to 24 months after enrollment. |
|
|
|
| Secondary | Anytime 6-month Seizure-free Interval | 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. | Posted | Count of Participants | Participants | Baseline to 24 months after enrollment. |
|
|
|
| Other Pre-specified | Seizure Disability Weights | Seizure disability weights were determined for all enrolled children in each arm of the cluster randomized clinical trial (cRCT), beginning with information from enrollment, collected at each study visit, for the total duration of the study subject's enrollment in the study. For each follow-up visit, we computed average monthly seizure frequency over the reported study intervals. We time-weighted the disability weights across the 24-month study horizon for each enrolled child. The seizure disability weights are measured on a 0-1 scale, with "0" representing perfect health and "1" representing death. The seizure disability weight represents the severity of a non-fatal health state, with the lower score being more favorable. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale, 0 to 1. | Outcome measured for 24 months after enrollment. | clusters | clusters |
|
|
|
| 50 |
| 846 |
| 33 |
| 846 |
| 7 |
| 846 |
| EG001 | 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. | 54 | 826 | 25 | 826 | 7 | 826 |
|
| Malaria | General disorders | Systematic Assessment | Severe malaria reported to the community health workers and/or study physician and/or study staff |
|
| Stevens Johnson Syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment | Stevens Johnson Syndrome believed to be due to a new allergic reaction to an anti-seizure medication |
|
| Burns | Skin and subcutaneous tissue disorders | Systematic Assessment | The children with burns where those who sustained 2nd degree and/or 3rd degree burns regardless of whether seizures or epilepsy were thought to play a causal role in the burns. |
|
| Typhoid Fever | Infections and infestations | Systematic Assessment | Clinical and laboratory diagnosis of typhoid fever by a healthcare provider |
|
| Drug Injestion | General disorders | Systematic Assessment | Child who ingested a potentially harmful drug found in the home (not anti-seizure medication) |
|
| meningitis | Infections and infestations | Systematic Assessment |
|
| sexual assault | Social circumstances | Systematic Assessment | child study subject sexually assaulted |
|
| Fall resulting in fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | child study subject who fell and sustained fracture. |
|
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash of unknown etiology after outpatient evaluation. Treated symptomatically by physician, with resolution of the rash. |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | One child in TSC suffered a fracture when hit by a motorcycle. One child in EUC fell into a drainage ditch and broke his leg. Both children recovered with treatment. |
|
| Hydropneumothorax of unknown likely infectious etiology | Infections and infestations | Systematic Assessment | Hydropneumothorax, thought by physicians initially to be due to tuberculosis. Outpatient evaluation, including drainage of the hydropneumothorax, showed no evidence of TB. Treated with antibiotics as outpatient with recovery. |
|
| Clinic visit for sudden increase in seizure frequency | Nervous system disorders | Systematic Assessment | 2 children in EUC had sudden increase in seizure frequency, for which the family sought emergency room evaluation. Anti-seizure medication increased, and both children discharged improved. |
|
| burn | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild burns treated as outpatient with recovery. |
|
| accidental drug ingestion/overdose | General disorders | Systematic Assessment | 1 child in EUC evaluated for getting into a bottle of carbamazepine and taking several tablets, had drowsiness, and taken to emergency room where treated with recovery, and family education regarding keep medication out of reach of the young child. |
|
Not provided
Not provided
| Stunting |
|