Bridging the Childhood Epilepsy Treatment Gap in Africa

NCT04290975 | Completed Results DMC

• 2 other identifiers: 191283PACTR202003864779691
• Study Type: interventional
• Target: 1,672
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Epilepsy

Keywords

Epilepsy; Pediatric; Neurology; Nigeria; Task-shifting; Africa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• 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

• Diagnostic Accuracy

  Diagnostic accuracy measured at 1 month after enrollment.

• Mortality

  Deaths measured for 25 months after enrollment.

• Number of Children Who Experienced Status Epilepticus

  Baseline to 24 months after enrollment

Other Outcomes (1)

• Seizure Disability Weights

  Outcome measured for 24 months after enrollment.

Study Arms (2)

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.

Other: Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs)

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.

Other: Enhanced usual care for epilepsy (EUC)

Interventions

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).

Also known as: Task-shifted epilepsy care (TSC)

Task-shifted arm

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.

Also known as: Routine epilepsy care by physicians

Enhanced usual care arm

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Resident of Kano or Kaduna states and living in the Kano, Zaria, or Kaduna metropolitan areas of northern Nigeria
• Parent or guardian provided informed consent for the screening questionnaire given to the parent/guardian
• Parent or guardian informed consent, plus assent for children \>7 years able to provide assent, for epilepsy diagnostic evaluation if the screening for possible epilepsy is positive
• Diagnosed with possible epilepsy through initial screening, and then diagnosed with epilepsy upon further evaluation by an epilepsy-trained CHW working with the BRIDGE project, who may consult a BRIDGE physician for diagnostic questions
• Parent or guardian provided consent, and assent for children \>7 years able to provide assent, for enrollment in the cRCT of task-shifted epilepsy care versus enhanced physician epilepsy care

You may not qualify if:

• Children who have previously been diagnosed with epilepsy and are currently enrolled in other care and treatment, or who have been treated for epilepsy within three months prior to screening
• Children who are currently receiving care by a neurologist or neurosurgeon for a serious brain disorder (e.g., brain tumor, stroke)
• Lack of informed consent, and/or lack of assent from children \>7 years who are able to provide assent.Inability of the parent or guardian to communicate with healthcare providers in either Hausa or English
• Any child who screens positive for epilepsy, has epilepsy upon clinical evaluation, but does not live in Kano, Zaria, and Kaduna, and who is in the judgement of the parents and/or BRIDGE staff to be unable to comply with the study visits because of travel distance from home.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Aminu Kano Teaching Hospital: collaborator
• Ahmadu Bello University Teaching Hospital: collaborator
• Federal Neuro-Psychiatric Hospital, Kaduna: collaborator

Study Sites (3)

Federal Neuro-Psychiatric Hospital

Kaduna, Nigeria

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Ahmadu Bello University Teaching Hospital

Zaria, Nigeria

Location

Related Publications (10)

• 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.

  PMID: 23449175 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.

  PMID: 18280210 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.

  PMID: 12781390 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.

  PMID: 15694563 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.

  PMID: 22770914 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.

  PMID: 23021288 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.

  PMID: 23539548 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.

  PMID: 24655403 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.

  PMID: 19823570 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.

  PMID: 18557778 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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.

Results Point of Contact

• Title: Edwin Trevathan, MD, MPH, Amos Christie Chair in Global Health, Professor of Pediatrics & Neurology
• Organization: Vanderbilt Institute for Global Health, Vanderbilt University Medical Center

edwin.trevathan@vumc.org

6153229374

Study Officials

• Edwin Trevathan, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Aminu Taura, MBBS

  Aminu Kano Teaching Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Pediatrics, Vanderbilt Institute for Global Health

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 2, 2020
• Study Start: June 16, 2020
• Primary Completion: May 31, 2024
• Study Completion: July 15, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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.
• Access Criteria: Both internal and external investigators are required to submit a proposal requesting a dataset from the trial, describing the following elements in detail: 1. Investigator's name and affiliation 2. Hypothesis to be tested or investigation to be conducted 3. Background and relevant literature 4. Subjects eligible for inclusion in the analysis and dataset 5. List of variables of interest 6. Substantially detailed analysis plan 7. List of potential co-authors and collaborators

Locations

NG (3)