Bridging the Childhood Epilepsy Treatment Gap in Africa

NCT ID: NCT04290975

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2025-05-31

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.

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:

1. 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.

2. Assess socio-behavioral and implementation outcomes among providers, parents/guardians and patients in the cRCT. Outcome measures include: (1) Difference in baseline, 12- and 24-month intervention acceptability, appropriateness, and feasibility measures among providers in the task-shifted intervention arm of the cRCT; (2) Difference in baseline, 12- and 24-month quality of life, epilepsy knowledge and stigma, and trust in the healthcare system and providers among participants; (3) Comparison of 12- and 24-month quality of life, knowledge and stigma and trust measures among participants in the intervention and control arms.

3. Determine the cost-effectiveness of the task-shifted epilepsy care intervention. Direct costs of the intervention and EUC will include personnel costs (including CHW epilepsy training) and expenses for diagnostic (EEG, brain imaging) and laboratory tests and anti-epileptic drugs. Indirect costs will include travel time and time away from work for parents/guardians and change in school attendance for patients. Cost-effectiveness will be expressed as US dollars per disability adjusted life year (DALY) averted.

This project will also establish a brain disorders clinical research network for Hausa-speaking Africa and provide data for health system leaders and policymakers to scale-up task-shifted childhood epilepsy care.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Task-shifted arm

In the task-shifted arm, all children will be prescribed anti-epileptic medication and receive follow-up care from a CHW, with a physician consult available to the CHW as needed.

Group Type: EXPERIMENTAL

Task-shifting of follow-up care for pediatric epilepsy

Intervention Type: OTHER

For the intervention arm, follow-up care of children with epilepsy will be shifted to be performed primarily by Community Health Workers (CHWs) with specialized epilepsy training

Enhanced usual care arm

In the enhanced usual care arm, all children will be prescribed anti-epileptic medication and receive follow-up care from a physician, with a CHW collecting standardized data to mirror that of the intervention arm.

Group Type: ACTIVE_COMPARATOR

Enhanced usual care for pediatric epilepsy

Intervention Type: OTHER

For the intervention arm, follow-up care of children with epilepsy will be performed primarily by physicians, with CHWs serving to collect standardized data regarding outcomes

Interventions

Task-shifting of follow-up care for pediatric epilepsy

For the intervention arm, follow-up care of children with epilepsy will be shifted to be performed primarily by Community Health Workers (CHWs) with specialized epilepsy training

Intervention Type: OTHER

Enhanced usual care for pediatric epilepsy

For the intervention arm, follow-up care of children with epilepsy will be performed primarily by physicians, with CHWs serving to collect standardized data regarding outcomes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aminu Kano Teaching Hospital

OTHER

Sponsor Role: collaborator

Ahmadu Bello University Teaching Hospital

OTHER

Sponsor Role: collaborator

Federal Neuro-Psychiatric Hospital, Kaduna

UNKNOWN

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Edwin Trevathan

Professor of Neurology and Pediatrics, Director of Vanderbilt Institute for Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edwin Trevathan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Aminu Taura, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aminu Kano Teaching Hospital

Locations

Federal Neuro-Psychiatric Hospital

Kaduna, , Nigeria

Aminu Kano Teaching Hospital

Kano, , Nigeria

Ahmadu Bello University Teaching Hospital

Zaria, , Nigeria

Countries

Nigeria

References

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.

Reference Type: BACKGROUND

PMID: 23449175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18280210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12781390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15694563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22770914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23021288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23539548 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24655403 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19823570 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18557778 (View on PubMed)

Other Identifiers

PACTR202003864779691

Identifier Type: REGISTRY

Identifier Source: secondary_id

191283

Identifier Type: -

Identifier Source: org_study_id