EpilepsyNCT05321641
Evaluation Of A Mobile Messaging Service In Improving Adherence Of Anti-Seizure Medications
A study testing Mobile phone message reminders. in people with Epilepsy and Treatment Adherence, run by KEMRI-Wellcome Trust Collaborative Research Program at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Treatment Adherence
- What is being tested?
- Mobile phone message reminders.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- May 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have intellectual disability
- Do not have access to basic mobile phones
- Are currently enrolled in ongoing interventions aimed at improving their health care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of A Mobile Messaging Service (Text And / Or Graphic) In Improving Adherence With Ensured Supply Of Anti-Seizure Medications In People With Epilepsy In Kilifi And Nairobi, Kenya
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.
Read more
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:
- 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.
Read the detailed description
Improved outcomes for epilepsy treatment depend on a continuous supply and daily adherence to anti-seizure medications (ASMs). In Kilifi County, the treatment gap which includes both the diagnostic and adherence gap, is greater than 70% and investigators have found interruption of supply of ASMs to peripheral clinics, distance from clinic and lack of availability of ASMs, to be barriers to adherence. In Nairobi County, factors such as environment hazards, lack of social amenities and correlates of poverty are preponderant in slums, but the prevalence of epilepsy has not been studied in such settings and consequently, the adherence gap remains unknown. Innovative mobile Health (mHealth) strategies including messages delivered by mobile phones have been used to ensure an adequate supply of drugs in health centres, and daily mobile messages have improved adherence to medication in Human Immunodeficiency Virus (HIV) programs, for example. Text messaging requires that the patient has access to a mobile phone and can understand the text message. Multimedia messaging, such as simple pictures, may improve understanding of the necessity to take medication, particularly in people who are illiterate, and we will explore this as an avenue to improve uptake.
The investigators 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). The investigators aim is to i) describe the perceptions and perspectives of people with epilepsy and their caregivers on the use of text and graphic SMS reminders to improve adherence to ASMs, ii) compare the effectiveness of text versus graphic messaging service in improving adherence in people with epilepsy and to engage the County Departments of Health through current ongoing training and capacity building studies to maintain supply of ASMs in peripheral clinics iii) identify the factors associated with improvement in adherence, improved QoL and reduction in stigma among people with epilepsy and family members and iv) conduct cost-effectiveness assessment for the roll out of the intervention. Besides medication-related messages, there will be other messages, from previous community-based feedback, selected to address stigmatization and improve quality of life. Blood-level monitoring and adherence questionnaires at baseline and during subsequent follow up visits will be used to assess as measures of medication adherence. If found useful, this intervention may be applicable for self-managing other chronic conditions in under-resourced settings.
- Conditions
- Epilepsy, Treatment Adherence
- Being tested
- Mobile phone message reminders.
- Medical subject headings
- Epilepsy, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone message reminders.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Text SMS | Experimental | Adherence messages presented in both text form. Receives: Behavioral: Mobile phone message reminders. |
| Graphic SMS | Experimental | Adherence messages presented in graphic form. Receives: Behavioral: Mobile phone message reminders. |
| Both text and graphic | Experimental | Adherence messages presented in both text and graphic form. Receives: Behavioral: Mobile phone message reminders. |
| Control | Placebo comparator | Messages on public health promotion not related to epilepsy Receives: Behavioral: Mobile phone message reminders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months since baseline.
Secondary outcomes (2)
Changes in seizure frequency, from many seizures to fewer seizures.
These will be assessed by trained clinicians at the epilepsy clinics, through routine clinical examination.
Measured: 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.
These will be 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).
Measured: 12 months since baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KEMRI-Wellcome Trust Collaborative Research Program
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, African Population and Health Research Center
- Responsible party
- Sponsor
- Investigators
- Charles R Newton, MD, Study director, KEMRI-Wellcome Trust Collaborative Research ProgramSymon M Kariuki, DPhil, Principal investigator, KEMRI-Wellcome Trust Collaborative Research ProgramArjune Sen, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321641
- Sponsor's protocol ID
- KEMRI 4368
- Status last verified
- Apr 2022
- First submitted
- 7 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level anonymized data will be shared with the Sponsor. Summary-level statistical analyses will be shared with wider stakeholder engagement and the medical community. Information collected or generated during this study may be anonymised for use to support new research on epilepsy. Any future research using information from this study must first be approved by a local or national expert committee to make sure that the interests of participants and their communities are protected. Data will be managed by the data governance committee of KEMRI CGMRC.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of A Mobile Messaging Service (Text And / Or Graphic) In Improving Adherence With Ensured Supply Of Anti-Seizure Medications In People With Epilepsy In Kilifi And Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT05321641
- Acronym / sponsor ID
- KEMRI 4368
- Conditions
- Epilepsy, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- KEMRI-Wellcome Trust Collaborative Research ProgramUniversity, hospital or other
- Collaborators
- University of Oxford, African Population and Health Research Center
- Study start
- May 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
Improved outcomes for epilepsy treatment depend on a continuous supply and daily adherence to anti-seizure medications (ASMs). In Kilifi County, the treatment gap which includes both the diagnostic and adherence gap, is greater than 70% and investigators have found interruption of supply of ASMs to peripheral clinics, distance from clinic and lack of availability of ASMs, to be barriers to adherence. In Nairobi County, factors such as environment hazards, lack of social amenities and correlates of poverty are preponderant in slums, but the prevalence of epilepsy has not been studied in such settings and consequently, the adherence gap remains unknown. Innovative mobile Health (mHealth) strategies including messages delivered by mobile phones have been used to ensure an adequate supply of drugs in health centres, and daily mobile messages have improved adherence to medication in Human Immunodeficiency Virus (HIV) programs, for example. Text messaging requires that the patient has access to a mobile phone and can understand the text message. Multimedia messaging, such as simple pictures, may improve understanding of the necessity to take medication, particularly in people who are illiterate, and we will explore this as an avenue to improve uptake.
The investigators 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). The investigators aim is to i) describe the perceptions and perspectives of people with epilepsy and their caregivers on the use of text and graphic SMS reminders to improve adherence to ASMs, ii) compare the effectiveness of text versus graphic messaging service in improving adherence in people with epilepsy and to engage the County Departments of Health through current ongoing training and capacity building studies to maintain supply of ASMs in peripheral clinics iii) identify the factors associated with improvement in adherence, improved QoL and reduction in stigma among people with epilepsy and family members and iv) conduct cost-effectiveness assessment for the roll out of the intervention. Besides medication-related messages, there will be other messages, from previous community-based feedback, selected to address stigmatization and improve quality of life. Blood-level monitoring and adherence questionnaires at baseline and during subsequent follow up visits will be used to assess as measures of medication adherence. If found useful, this intervention may be applicable for self-managing other chronic conditions in under-resourced settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Text SMS | Experimental | Behavioral: Mobile phone message reminders.Adherence messages presented in both text form. |
| Graphic SMS | Experimental | Behavioral: Mobile phone message reminders.Adherence messages presented in graphic form. |
| Both text and graphic | Experimental | Behavioral: Mobile phone message reminders.Adherence messages presented in both text and graphic form. |
| Control | Placebo comparator | Behavioral: Mobile phone message reminders.Messages on public health promotion not related to epilepsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have intellectual disability
- Do not have access to basic mobile phones
- Are currently enrolled in ongoing interventions aimed at improving their health care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Both text and graphic, Control, Graphic SMS, Text SMS |
Primary outcome
Adherence to anti-seizure medications
Time frame: 12 months since baseline.
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.
2 secondary outcomes
Changes in seizure frequency, from many seizures to fewer seizures.
Time frame: 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.
Time frame: 12 months since baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes. Individual-level anonymized data will be shared with the Sponsor. Summary-level statistical analyses will be shared with wider stakeholder engagement and the medical community. Information collected or generated during this study may be anonymised for use to support new research on epilepsy. Any future research using information from this study must first be approved by a local or national expert committee to make sure that the interests of participants and their communities are protected. Data will be managed by the data governance committee of KEMRI CGMRC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles R Newton, MD study director
KEMRI-Wellcome Trust Collaborative Research Program
Symon M Kariuki, DPhil principal investigator
KEMRI-Wellcome Trust Collaborative Research Program
Arjune Sen, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone message reminders. in people with Epilepsy and Treatment Adherence, run by KEMRI-Wellcome Trust Collaborative Research Program at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to anti-seizure medications (time frame: 12 months since baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.