Evaluation Of A Mobile Messaging Service In Improving Adherence Of Anti-Seizure Medications

NCT05321641 | Unknown

• 1 other identifier: KEMRI 4368
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy; Treatment Adherence

Outcome Measures

Primary Outcomes (1)

• Adherence to anti-seizure medications

  This will be 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.

  12 months since baseline.

Secondary Outcomes (2)

• Changes in seizure frequency, from many seizures to fewer seizures.

  12 months since baseline.

• 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.

  12 months since baseline.

Other Outcomes (1)

• Pharmacovigilance for unwanted drug-related adverse events as reported by participants and confirmed using standardized questionnaire.

  12 months since baseline.

Study Arms (4)

Text SMS

EXPERIMENTAL

Adherence messages presented in both text form.

Behavioral: Mobile phone message reminders.

Graphic SMS

EXPERIMENTAL

Adherence messages presented in graphic form.

Behavioral: Mobile phone message reminders.

Both text and graphic

EXPERIMENTAL

Adherence messages presented in both text and graphic form.

Behavioral: Mobile phone message reminders.

Control

PLACEBO COMPARATOR

Messages on public health promotion not related to epilepsy

Behavioral: Mobile phone message reminders.

Interventions

Mobile phone message reminders. BEHAVIORAL

Utilising mobile messaging service to send reminders to people with epilepsy to take antiseizure medications and sending reminders to primary health facilities to restock anti-seizure medications.

Both text and graphic; Control; Graphic SMS; Text SMS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have intellectual disability
• Do not have access to basic mobile phones
• Are currently enrolled in ongoing interventions aimed at improving their health care

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program: lead
• University of Oxford: collaborator
• African Population and Health Research Center: collaborator

Study Sites (1)

KEMRI Wellcome Trust Research Programme

Kilifi, 80108, Kenya

Location

MeSH Terms

Conditions

Epilepsy; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Charles R Newton, MD

  KEMRI-Wellcome Trust Collaborative Research Program

  STUDY DIRECTOR

• Symon M Kariuki, DPhil

  KEMRI-Wellcome Trust Collaborative Research Program

  PRINCIPAL INVESTIGATOR

• Arjune Sen, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants can tell if they are receiving adherence messages or general public health messages. The clinicians will interact with participants and may therefore get to know what kind of messages they receive. However, the investigators, who will conduct the analysis and the assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We plan to randomize 1200 people with epilepsy at each site, from a defined area in Kilifi and Nairobi County, Kenya. They will be divided into four groups of 300 each, to receive either text SMS, graphic SMS, both text and graphic or SMS on public health promotion not related to epilepsy e.g. use of bednets (for comparison).

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 11, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 2-5 years after the study completion.
• Access Criteria: Approved proposal and analysis plan and permission to access the data from the data governance committee.

Locations

KE (1)