EpilepsyBRIDGENCT04290975
Bridging the Childhood Epilepsy Treatment Gap in Africa
A study testing Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs) in people with Epilepsy, run by Vanderbilt University Medical Center at 3 sites in Nigeria.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,672 participants
- Where
- 3 sitesNigeria
- Study dates
- 16 Jun 2020to 15 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Nigeria3 sites
Federal Neuro-Psychiatric Hospital
Kaduna
Aminu Kano Teaching Hospital
Kano
Ahmadu Bello University Teaching Hospital
Zaria
About this study
Official title: Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)
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.
Read the detailed description
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.
- Conditions
- Epilepsy
- Being tested
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
- Keywords
- Epilepsy, Pediatric, Neurology, Nigeria, Task-shifting, Africa
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs)Other
Also called Task-shifted epilepsy care (TSC)
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).
Enhanced usual care for epilepsy (EUC)Other
Also called Routine epilepsy care by physicians
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced usual care for epilepsy (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline to 24 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start16 Jun 2020
- Primary completion31 May 2024
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aminu Kano Teaching Hospital, Ahmadu Bello University Teaching Hospital, Federal Neuro-Psychiatric Hospital, Kaduna
- Responsible party
- Principal investigator, Edwin Trevathan, Vanderbilt University Medical Center
- Investigators
- Edwin Trevathan, MD, MPH, Principal investigator, Vanderbilt University Medical CenterAminu Taura, MBBS, Principal investigator, Aminu Kano Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290975
- Sponsor's protocol ID
- 191283
- Other IDs
- PACTR202003864779691
- Acronym
- BRIDGE
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2020
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigators and research personnel will share deidentified data from the study in multiple modes: 1. Data files for internal (study) investigators 2. Data files for external (non-study) investigators 3. Comprehensive publication of the results for the primary and secondary outcomes
Publications
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.
PubMed 23449175de 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.
PubMed 18280210Diop 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.
PubMed 12781390Ndoye 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.
PubMed 15694563Mbuba 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.
PubMed 22770914Newton 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.
PubMed 23021288Wilmshurst 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.
PubMed 23539548Wilmshurst 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.
PubMed 24655403Mbuba 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.
PubMed 19823570Mbuba 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.
PubMed 18557778