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.: PACTR202204553167288 Date of Approval: 20/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation Of A Mobile Messaging Service In Improving Adherence Of Anti-Seizure Medications
Official scientific title Evaluation Of A Mobile Messaging Service in Improving Adherence With Ensured Supply of Anti-Seizure Medications in People With Epilepsy in Kilifi and Nairobi, Kenya (SMS Trial)
Brief summary describing the background and objectives of the trial This will be a behavioural intervention with no investigational medicinal product. The intervention will be a mobile messaging service that sends short messaging service (SMS) as texts or graphics to people with epilepsy to remind them to take their medication and to refill their prescription and educational messages to share important messages tackling stigma and tips to improve quality of life. The investigators will also engage peripheral health facilities where people with epilepsy (PWE) participating in the study go for ASM refills, in collaboration with the respective county departments of health, to maintain adequate supply of anti-seizure medications through: i. ongoing capacity building studies in Kilifi such as the mental health Gap Action Programme-Intervention Guide (mhGAP-IG) training which is empowering primary healthcare providers at peripheral health facilities to identify and manage epilepsy and other mental health disorders. ii. supporting healthcare providers at peripheral facilities through in person visits, if the COVID-19 situation, permits or by telephone or standard message reminders to restock their ASM supply. The participants in the no-intervention group will receive "placebo" health messages not related to epilepsy such as use of bednets. The SMS reminders will be sent at a frequency that will be agreed upon during pre-study engagements with potential participants, whether daily, weekly, or monthly. The participants will be able to respond to these texts to report on their health status and any adverse events. To evaluate whether SMS reminders improve adherence, we will use: i. Self-reporting adherence scales- the Morisky Medication Adherence Scale (MMAS-8) ii. Measurement of ASM plasma levels at 12 months from baseline.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMS Trial
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Mobile message reminders to improve adherence to treatment
Anticipated trial start date 01/05/2022
Actual trial start date 04/10/2022
Anticipated date of last follow up 31/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT05321641 Clinicaltrials.gov
KEMRI 4368 Kenya Medical Research Institute Scientific and Ethics Review Unit
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Text SMS 12 months Adherence messages presented in text form. 300
Experimental Group Voice messages Once or twice a day 12 months Adherence messages recorded as a voice call 300
Experimental Group Both text and audio messages Once or twice a day 12 months Adherence messages presented in text form and voice recorded calls 300
Control Group Control 12 months Messages on public health promotion not related to epilepsy 300 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children or adults with a diagnosis of epilepsy ascertained by a clinician at the epilepsy clinic Taking anti-seizure medications at the time of the study Living within an area defined as the Kilifi Health Demographic Surveillance System, or the Nairobi Urban Health and Demographic Surveillance System at the time of the study or attending the epilepsy clinic in Kilifi or a KAWE-led clinic in Nairobi Able to give written informed consent or assent in addition to parental consent (if aged between 13 and 17 years old) to participate in the study either by themselves or in the presence of an independent witness Have intellectual disability Do not have access to basic mobile phones Are currently enrolled in ongoing interventions aimed at improving their health care 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 100 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 31/01/2022 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Way, Nairobi Nairobi 54840-002 Kenya
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 21/02/2022 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Off Waiyaki Way, Upper Kabete Nairobi 30623 001 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to anti-seizure medications measured through self-reports scales (eg the Morisky Medication Adherence Scale (MMAS-8)), checking record logs for correct intake of drugs and refill rates- validated by optimal and detectable levels in blood. Baseline, 3, 6 and 12 month
Secondary Outcome Changes in seizure frequency, from many seizures to fewer seizures assessed by trained clinicians at the epilepsy clinics, through routine clinical examination. Baseline, 3, 6 and 12 months
Secondary Outcome Changes in stigma scores and quality of life scores, from higher scores to less scores for stigma and from lower scores to higher scores for quality of life assessed with standardized and locally adapted scales (assessed with the Kilifi Epilepsy Stigma Scale and World Health Organization Quality of Life Scale (WHOQOL-BREF), respectively). Baseline, 3, 6 and 12 months
Secondary Outcome Pharmacovigilance for unwanted drug-related adverse events as reported by participants will be assessed and confirmed using Common Toxicity Criteria for Adverse Events (CTCAE). Baseline, 3, 6 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Wellcome Trust Research Programme Off Hospital Road, Kilifi Kilifi 230-80108 Kenya
Africa Population and Health Research Centre Kirawa Road Nairobi 10787 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health Research Enterprise Road Southampton SO16 7NS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington Square Oxford OXI 2JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
African Population and Health Research Center Kitisuru Nairobi 10787 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Symon Kariuki skariuki@kemri-wellcome.org +254723926339 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Public Enquiries Mercy Odhiambo matieno@kemri-wellcome.org +254723763073 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Scientific Enquiries Charles Newton cnewton@kemri-wellcome.org +254709983000 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Programme
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data that underlie the results reported in this study will be available for sharing immediately following publication with researchers and investigators for use in approved proposals or for individual participant meta analysis. Requests should be directed to skariuki@kemriwellcome.org Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose to achieve aims in the approved proposal or for individual participant meta-analysis
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