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ISRCTN
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ISRCTN35680481
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ClinicalTrials.gov identifier
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Public title
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Kilifi Epilepsy Education Program (KEEP): An intervention to reduce the epilepsy treatment gap
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Scientific title
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The efficacy of an education intervention for people with epilepsy and their caregivers (KEEP): a controlled randomised study
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Acronym
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KEEP
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Serial number at source
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083744; KEMRI/National Ethics Review Committee: 1455
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Study hypothesis
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An intervention, targeting people with epilepsy (PWE), their caregiver and health care providers, has reduced the epilepsy treatment gap in Kilifi.
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Ethics approval
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KEMRI/National Ethics Review Committee approved on the 6th May 2009 (ref: 1455)
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Study design
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Single centre interventional randomised controlled trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Epilepsy
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Participants - inclusion criteria
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1. PWE and their caregivers
2. Both male and female, no age limits
3. Where the person with epilepsy is a child, only caregiver will participate
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Participants - exclusion criteria
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1. PWE who refuse informed consent
2. Children whose parents refuse informed consent
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Anticipated start date
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01/08/2009
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Anticipated end date
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01/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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We have identified 740 PWE in the Kilifi Demographic Surveillance System
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Interventions
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Each person with epilepsy is randomised to received the intervention or act as a control. Those that are allocated to the intervention will have a care giver identifier and this person together with the person with epilepsy will receive education at a designated session, which will be re-enforced at clinical attendance. In addition, the traditional healer that the person with epilepsy may consult will be approached to be involved in the education programme; the education programme includes information on the causes and medical treatment of epilepsy.
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Primary outcome measure(s)
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Adherence of PWE to antiepileptic drugs (AEDs) as measured by drug levels. Plasma phenobarbital or phenytoin concentrations will be measured using an Abbott TDx FLx fluorescence polarisation immunoassay analyser (Abbott Laboratories, Diagnostic Division, Abbott Park, IL, USA). Therapeutic levels of AEDs will be defined as plasma concentrations ranging between 10 - 40 μg/mL, for both phenobarbital and phenytoin. Detectable levels of AEDs will be defined as plasma concentrations of greater than or equal to 1 μg/ml for both phenobarbital and phenytoin. Assessed at one year and four years after study onset.
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Secondary outcome measure(s)
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Assessed at one year and four years after study onset:
1. Seizure frequency, measured by a questionnaire
2. Quality of life of PWE, measured by quality of life questionnaire using Likert scale (0 = not at all, 1 = rarely, 2 = sometimes, 3 = most of the time, 4 = always)
3. Knowledge, beliefs and attitudes about epilepsy, measured by the Epilepsy beliefs and attitude questionnaire using Likert Scale (0 = don’t know, 1 = not at all, 2 = believe a little, 3 = totally believe)
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 083744)
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Trial website
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Publications
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Contact name
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Ms
Caroline
Kathomi
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Address
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KEMRI/Wellcome Trust Programme
P.O. Box 230
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City/town
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Kilifi
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Zip/Postcode
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80108
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Country
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Kenya
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Email
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ckathomi@kilifi.kemri-wellcome.org
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Sponsor
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University College London (UCL) (UK)
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Address
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Institute of Child Health
Guildford Street
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City/town
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London
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Zip/Postcode
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WC1N
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Country
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United Kingdom
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Email
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cnewton@ich.ucl.ac.uk
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Sponsor website:
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http://www.ich.ucl.ac.uk/
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Date applied
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08/01/2010
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Last edited
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11/01/2010
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Date ISRCTN assigned
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11/01/2010
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