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

NCT05321641 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2022-04-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mobile phone message reminders.

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.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER
  • African Population and Health Research Center

    collaborator OTHER
  • KEMRI-Wellcome Trust Collaborative Research Program

    lead OTHER

Principal Investigators

  • Charles R Newton, MD · KEMRI-Wellcome Trust Collaborative Research Program

  • Symon M Kariuki, DPhil · KEMRI-Wellcome Trust Collaborative Research Program

  • Arjune Sen, PhD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321641 on ClinicalTrials.gov