EpilepsyNCT05491369
Effectiveness of an Epilepsy Application for Self-management in Viet Nam
A study testing Epilepsy application in people with Epilepsy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial summary
Epilepsy is a common neurological disease which effects all genders, ages and geographic regions. Self-management refers to "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Epilepsy application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Sep 2022to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with epilepsy diagnosed and treated by neurologists
- Smartphone users
Who cannot join
- Substance dependence
- Suicidality
- Limited language proficiency
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 700000
University Medical Center at Ho Chi Minh City
Ho Chi Minh City, 70000
About this study
Official title: Effectiveness of an Epilepsy Educational Application for Self-management in Viet Nam: a Randomized Clinical Trial
Epilepsy is a common neurological disease which effects all genders, ages and geographic regions. Self-management refers to "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions". Optimal self-management may improve self-efficacy, knowledge about epilepsy of people with epilepsy (PWE) and family, medical compliance and avoidance of seizure triggers. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management
Read the detailed description
Epilepsy which affects over 70 million people worldwide, is one of the most common neurological diseases. Epilepsy is "a disease characterized by an enduring predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological, and social consequences of this condition." Therefore, self-management plays a crucial role for people with epilepsy (PWE) to adapt their lifestyles and behaviors for those long-lasting changes. Self-management is a dynamic, interactive, and daily process in which individuals engage to manage a chronic illness. Self-management is "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions." Optimal self-management may improve self-efficacy, knowledge about epilepsy of PWE and family, medical compliance, and avoidance of seizure triggers.
Mobile health (mHealth) epilepsy application (apps) refers to any digital software (e.g., via the Internet, mobile device, wearable, or desktop platforms) capable of collecting, tracking, or sharing data while interacting with patients about their epilepsy health information. Recent studies have reported that mHealth applications improved the management of people with chronic illnesses, including epilepsy. In the digital era, smartphones are becoming more and more popular worldwide. In 2016, there were 24.8 million (30% of the population) smartphone users in Viet Nam, and this share is predicted to rise by 40 percent by 2021. Nanacara is an educational app for PWE to improve self-management.
A systematic review showed 20 English apps designed to improve self-management for PWE. Only one randomized clinical trial (RCT) study showed the effectiveness of mobile apps in increasing self-management for PWE. This result implied the lack of validation study related to the clinical use of the epilepsy apps. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management.
- Conditions
- Epilepsy
- Being tested
- Epilepsy application
- Keywords
- Epilepsy, Self-management, Mobile health application, Effectiveness
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epilepsy applicationOther
Nanacara is an epilepsy application which helps people with epilepsy to self-manage their conditions.
| Study group | Role | What they receive |
|---|---|---|
| Application users | Active comparator | Participants will use application for self-management. Receives: Other: Epilepsy application |
| Control group | No intervention | Participants will be in the waiting list which don't use the app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epilepsy Self-Management Scale (ESMS)
The ESMS (DiIorio et al., 2004) is a 38-item scale categorized into 5 domains: information, medication, seizure, safety and lifestyle management. Higher scores indicate more frequent use of self-management strategies.
Measured: 3-month
Quality of Life in Epilepsy Inventory (QOLIE-31)
The QOLIE-31 reflects the patient's subjective well-being toward his or her QOL in various aspects related to epilepsy, with higher scores indicating better wellbeing.
Measured: 3-month
Secondary outcomes (2)
PHQ9 (Patient Health Questionnaire scale)
PHQ9 is a self-reported questionnaire to assess depression.
Measured: 3-month
GAD7 (Generalized Anxiety Disorder scale)
Assess generalized anxiety
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial (RCT): parallel, two-arm design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minh-An Thuy Le, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Minh-An T Le, Master, Study chair, University of Medicine and Pharmacy at HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491369
- Sponsor's protocol ID
- 22416 - ĐHYD
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoo S, Lim K, Baek H, Jang SK, Hwang GY, Kim H, Hwang H. Developing a mobile epilepsy management application integrated with an electronic health record for effective seizure management. Int J Med Inform. 2020 Feb;134:104051. doi: 10.1016/j.ijmedinf.2019.104051. Epub 2019 Dec 4.
PubMed 31837500Pandey DK, Dasgupta R, Levy J, Wang H, Serafini A, Habibi M, Song W, Shafer PO, Loeb JA. Enhancing epilepsy self-management and quality of life for adults with epilepsy with varying social and educational backgrounds using PAUSE to Learn Your Epilepsy. Epilepsy Behav. 2020 Oct;111:107228. doi: 10.1016/j.yebeh.2020.107228. Epub 2020 Jun 27.
PubMed 32599431Le Marne FA, Butler S, Beavis E, Gill D, Bye AME. EpApp: Development and evaluation of a smartphone/tablet app for adolescents with epilepsy. J Clin Neurosci. 2018 Apr;50:214-220. doi: 10.1016/j.jocn.2018.01.065.
PubMed 29422360Si Y, Xiao X, Xia C, Guo J, Hao Q, Mo Q, Niu Y, Sun H. Optimising epilepsy management with a smartphone application: a randomised controlled trial. Med J Aust. 2020 Apr;212(6):258-262. doi: 10.5694/mja2.50520. Epub 2020 Feb 24.
PubMed 32092160
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Epilepsy Educational Application for Self-management in Viet Nam: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05491369
- Acronym / sponsor ID
- 22416 - ĐHYD
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Self-management, Mobile health application, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Aug 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.
Epilepsy is a common neurological disease which effects all genders, ages and geographic regions. Self-management refers to "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions". Optimal self-management may improve self-efficacy, knowledge about epilepsy of people with epilepsy (PWE) and family, medical compliance and avoidance of seizure triggers. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management
Detailed description
Epilepsy which affects over 70 million people worldwide, is one of the most common neurological diseases. Epilepsy is "a disease characterized by an enduring predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological, and social consequences of this condition." Therefore, self-management plays a crucial role for people with epilepsy (PWE) to adapt their lifestyles and behaviors for those long-lasting changes. Self-management is a dynamic, interactive, and daily process in which individuals engage to manage a chronic illness. Self-management is "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions." Optimal self-management may improve self-efficacy, knowledge about epilepsy of PWE and family, medical compliance, and avoidance of seizure triggers.
Mobile health (mHealth) epilepsy application (apps) refers to any digital software (e.g., via the Internet, mobile device, wearable, or desktop platforms) capable of collecting, tracking, or sharing data while interacting with patients about their epilepsy health information. Recent studies have reported that mHealth applications improved the management of people with chronic illnesses, including epilepsy. In the digital era, smartphones are becoming more and more popular worldwide. In 2016, there were 24.8 million (30% of the population) smartphone users in Viet Nam, and this share is predicted to rise by 40 percent by 2021. Nanacara is an educational app for PWE to improve self-management.
A systematic review showed 20 English apps designed to improve self-management for PWE. Only one randomized clinical trial (RCT) study showed the effectiveness of mobile apps in increasing self-management for PWE. This result implied the lack of validation study related to the clinical use of the epilepsy apps. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial (RCT): parallel, two-arm design
| Arm | Type | Receives |
|---|---|---|
| Application users | Active comparator | Other: Epilepsy applicationParticipants will use application for self-management. |
| Control group | No intervention | –Participants will be in the waiting list which don't use the app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with epilepsy diagnosed and treated by neurologists
- Smartphone users
Key exclusion criteria (3 listed)
- Substance dependence
- Suicidality
- Limited language proficiency
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 |
|---|---|---|
| Epilepsy applicationNanacara is an epilepsy application which helps people with epilepsy to self-manage their conditions. | Other | Application users |
Primary outcome
Epilepsy Self-Management Scale (ESMS)
Time frame: 3-month
The ESMS (DiIorio et al., 2004) is a 38-item scale categorized into 5 domains: information, medication, seizure, safety and lifestyle management. Higher scores indicate more frequent use of self-management strategies.
Quality of Life in Epilepsy Inventory (QOLIE-31)
Time frame: 3-month
The QOLIE-31 reflects the patient's subjective well-being toward his or her QOL in various aspects related to epilepsy, with higher scores indicating better wellbeing.
2 secondary outcomes
PHQ9 (Patient Health Questionnaire scale)
Time frame: 3-month
GAD7 (Generalized Anxiety Disorder scale)
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Results publication: PubMed 31837500Yoo S, Lim K, Baek H, Jang SK, Hwang GY, Kim H, Hwang H. Developing a mobile epilepsy management application integrated with an electronic health record for effective seizure management. Int J Med Inform. 2020 Feb;134:104051. doi: 10.1016/j.ijmedinf.2019.104051. Epub 2019 Dec 4.
- Results publication: PubMed 32599431Pandey DK, Dasgupta R, Levy J, Wang H, Serafini A, Habibi M, Song W, Shafer PO, Loeb JA. Enhancing epilepsy self-management and quality of life for adults with epilepsy with varying social and educational backgrounds using PAUSE to Learn Your Epilepsy. Epilepsy Behav. 2020 Oct;111:107228. doi: 10.1016/j.yebeh.2020.107228. Epub 2020 Jun 27.
- Results publication: PubMed 29422360Le Marne FA, Butler S, Beavis E, Gill D, Bye AME. EpApp: Development and evaluation of a smartphone/tablet app for adolescents with epilepsy. J Clin Neurosci. 2018 Apr;50:214-220. doi: 10.1016/j.jocn.2018.01.065.
- Results publication: PubMed 32092160Si Y, Xiao X, Xia C, Guo J, Hao Q, Mo Q, Niu Y, Sun H. Optimising epilepsy management with a smartphone application: a randomised controlled trial. Med J Aust. 2020 Apr;212(6):258-262. doi: 10.5694/mja2.50520. Epub 2020 Feb 24.
- Individual participant dataSharing planned: No
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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.
Minh-An T Le, Master study chair
University of Medicine and Pharmacy at HCMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epilepsy application in people with Epilepsy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
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 2 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: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epilepsy Self-Management Scale (ESMS) (time frame: 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491369, which also lists 4 linked publications.
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 13 Apr 2025.