Kilifi Epilepsy Education Program (KEEP): An intervention to reduce the epilepsy treatment gap
| ISRCTN | ISRCTN35680481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35680481 |
| Secondary identifying numbers | 083744; KEMRI/National Ethics Review Committee: 1455 |
- Submission date
- 08/01/2010
- Registration date
- 11/01/2010
- Last edited
- 24/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Caroline Kathomi
Scientific
Scientific
KEMRI/Wellcome Trust Programme
P.O. Box 230
Kilifi
80108
Kenya
| ckathomi@kilifi.kemri-wellcome.org |
Study information
| Study design | Single centre interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy of an education intervention for people with epilepsy and their caregivers (KEEP): a controlled randomised study |
| Study acronym | KEEP |
| Study objectives | An intervention, targeting people with epilepsy (PWE), their caregiver and health care providers, has reduced the epilepsy treatment gap in Kilifi. |
| Ethics approval(s) | KEMRI/National Ethics Review Committee approved on the 6th May 2009 (ref: 1455) |
| Health condition(s) or problem(s) studied | Epilepsy |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 = dont know, 1 = not at all, 2 = believe a little, 3 = totally believe) |
| Overall study start date | 01/08/2009 |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | We have identified 740 PWE in the Kilifi Demographic Surveillance System |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. PWE who refuse informed consent 2. Children whose parents refuse informed consent |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/08/2012 |
Locations
Countries of recruitment
- Kenya
Study participating centre
KEMRI/Wellcome Trust Programme
Kilifi
80108
Kenya
80108
Kenya
Sponsor information
University College London (UCL) (UK)
University/education
University/education
Institute of Child Health
Guildford Street
London
WC1N
United Kingdom
| cnewton@ich.ucl.ac.uk | |
| Website | http://www.ich.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 083744)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2014 | Yes | No |
