Kilifi Epilepsy Education Program (KEEP): An intervention to reduce the epilepsy treatment gap
| ISRCTN | ISRCTN35680481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35680481 |
| Protocol serial number | 083744; KEMRI/National Ethics Review Committee: 1455 |
| Sponsor | University College London (UCL) (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 083744) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
KEMRI/Wellcome Trust Programme
P.O. Box 230
Kilifi
80108
Kenya
| ckathomi@kilifi.kemri-wellcome.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
Assessed at one year and four years after study onset: |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 740 |
| 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
80108
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
