Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003864779691 Date of Approval: 05/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)
Official scientific title Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BRIDGE
Disease(s) or condition(s) being studied Epilepsy,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Task-shifting care to community health workers
Anticipated trial start date 01/05/2020
Actual trial start date 19/06/2020
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1530
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
VUMC IRB 191283 R01 NS113171
NCT04290975 clinicaltrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Task shifted care N/A 24 months follow-up 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 765
Control Group Enhanced usual care N/A 24 months follow-up 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 765 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/09/2019 Vanderbilt University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1313 21st Ave S, Suite 505 Nashville 37203 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/10/2019 Aminu Kano Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PMB 3452 Zaria Road Kano 99999 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/10/2019 Ministry of Health and Human Services
Ethics Committee Address
Street address City Postal code Country
Independence Way PMB 2014 Kaduna 99999 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of children in each arm of the study who are seizure-free Must be seizure-free for 6 or more months at the 24-month visit follow-up visit
Secondary Outcome 75% reduction in seizure frequency Evaluated at 24 months in both arms compared to enrollment baseline data
Secondary Outcome Seizure freedom (6 months or longer) in response to the first AED prescribed 6 months after enrollment of final subject
Secondary Outcome Diagnostic accuracy among study subjects in both arms, determined by blinded physicians Evaluated by blinded physicians at 1, 6, 12, 18, and 24 months after enrollment
Secondary Outcome Differences in mortality between study arms that cannot be explained by potential differences in disease severity Once at study conclusion 24 months after enrollment of final subject
Secondary Outcome Difference in frequency of status epilepticus among children in both arms Once at study conclusion 24 months after enrollment of final subject
Secondary Outcome Differences in morbidity, including neurodevelopmental morbidity, associated with epilepsy between study arms that emerged during the cRCT Once, at study conclusion 24 months after enrollment of final subject
Secondary Outcome Differences by study arm in number and type of diagnostic tests (e.g., MRIs, EEGs) ordered Once, at study conclusion 24 months after enrollment of final subject
Secondary Outcome Percentage adherence by CHWs to protocol in the task-shifted arm Once, at study conclusion 24 months after enrollment of final subject
Secondary Outcome 6-month seizure-free interval at any point during follow-up Assessed at 4 time points during 24-month follow-up: 6, 12, 18, and 24 months
Secondary Outcome Comparison of care costs between task-shifted and enhanced usual care study arms Assessed throughout study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital PMB 3452 Zaria Road Kano Nigeria
Federal Neuropsychiatric Hospital Barnawa PMB 27187 Barnawa Nigeria
Ahmadu Bello University Teaching Hospital PMB 06 Shika Zaria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Neurological Diseases and Stroke.National Institutes of Health PO Box 5801 Bethesda 20824 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Vanderbilt University Medical Center 1211 Medical Center Dr Nashville 37232 United States of America Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edwin Trevathan edwin.trevathan@vumc.org +16153434174 2525 West End, Suite 750
City Postal code Country Position/Affiliation
Nashville 37203 United States of America Professor of Pediatrics and Neurology
Role Name Email Phone Street address
Public Enquiries Donna Ingles donna.j.ingles@vumc.org +16153433555 2525 West End Ave Suite 750
City Postal code Country Position/Affiliation
Nashville 37203 United States of America Senior Program Manager Institute for Global Health
Role Name Email Phone Street address
Scientific Enquiries Donna Ingles donna.j.ingles@vumc.org +16153433555 2525 West End Ave Suite 750
City Postal code Country Position/Affiliation
Nashville 37203 United States of America Senior Program Manager Institute for Global Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The principal investigators and research personnel will share the data from the study in multiple modes: a. Data files for internal (study) investigators b. Data files for external (non-study) investigators c. Timely and comprehensive publication of the results for the primary and secondary outcomes d. Public-access data files supplied to NIH Data De-identification The data team at Vanderbilt Institute for Global Health (VIGH) will be the official repository of all study data. As such, the data received will be de-identified to a certain extent prior to submission from the clinical sites in Kano, Zaria, and Kaduna. The statistical team will not collect any names, addresses, telephone numbers, medical record numbers, photographs, or any other information that might uniquely identify an individual. There are some data items that will be collected as part of the study, but which will be deleted prior to the release of any data to an external investigator. These items include: date of birth, and date of death. In addition, any unusual physical or demographic characteristics of the participants, such as unusual height or weight or the diagnosis of a rare condition, will also be modified or deleted. In general, there should be no reason to include any form of patient listings in the study. If there is a compelling reason to include a patient listing, none of the potentially identifying information listed above (such as date of birth, etc.) will be listed. Study Protocol 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: a. Investigator’s name and affiliation b. Hypothesis to be tested or investigation to be conducted c. Background and relevant literature d. Subjects eligible for inclusion in the analysis and dataset e. List of variables of interest f. Substantially detailed analysis plan g. List of potential co-authors and collaborators The proposal must be submitted to the contact Principal Investigator (PI) for circulation to the BRIDGE Executive Committee (EC). The PI will add his estimate of the staff time involved in creating the data file, as well as an estimated date for when the file will be ready. This will be done prior to circulating the proposal to the EC. The EC will review the proposal for feasibility and for priority. Per NIH rules, the EC cannot place a limit on the questions to be asked of the data, but can comment on whether the data collected by the trial can adequately answer the question. The EC will vote on the request within one month of receipt from the PI/PD, unless further clarification is requested from the submitting investigator. In the case of a revised submission or submission of requested clarification, theEC will conduct a final vote on the request within one month. The PI/PD will notify the requesting investigator of the result of the vote and the expected date of file completion, taking into account the priority voted by the EC. If the request is approved, the PI/PD will send a confidentiality agreement stipulating that the data file is to be used only for the purpose described in the proposal and that the requesting investigator must retain control over the file at all times. The requesting investigator is further obligated to supply quarterly progress reports on their analysis/investigation and to supply draft and final manuscripts.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information