Condition category
Nervous System Diseases
Date applied
08/01/2010
Date assigned
11/01/2010
Last edited
24/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Caroline Kathomi

ORCID ID

Contact details

KEMRI/Wellcome Trust Programme
P.O. Box 230
Kilifi
80108
Kenya
ckathomi@kilifi.kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

083744; KEMRI/National Ethics Review Committee: 1455

Study information

Scientific title

The efficacy of an education intervention for people with epilepsy and their caregivers (KEEP): a controlled randomised study

Acronym

KEEP

Study hypothesis

An intervention, targeting people with epilepsy (PWE), their caregiver and health care providers, has reduced the epilepsy treatment gap in Kilifi.

Ethics approval

KEMRI/National Ethics Review Committee approved on the 6th May 2009 (ref: 1455)

Study design

Single centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 = don’t know, 1 = not at all, 2 = believe a little, 3 = totally believe)

Overall trial start date

01/08/2009

Overall trial end date

01/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

We have identified 740 PWE in the Kilifi Demographic Surveillance System

Participant exclusion criteria

1. PWE who refuse informed consent
2. Children whose parents refuse informed consent

Recruitment start date

01/08/2009

Recruitment end date

01/08/2012

Locations

Countries of recruitment

Kenya

Trial participating centre

KEMRI/Wellcome Trust Programme
Kilifi
80108
Kenya

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Institute of Child Health
Guildford Street
London
WC1N
United Kingdom
cnewton@ich.ucl.ac.uk

Sponsor type

University/education

Website

http://www.ich.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 083744)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24447063

Publication citations

  1. Results

    Ibinda F, Mbuba CK, Kariuki SM, Chengo E, Ngugi AK, Odhiambo R, Lowe B, Fegan G, Carter JA, Newton CR, Evaluation of Kilifi epilepsy education programme: a randomized controlled trial., Epilepsia, 2014, 55, 2, 344-352, doi: 10.1111/epi.12498.

Additional files

Editorial Notes