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Effectiveness of an Epilepsy Application for Self-management in Viet Nam

Effectiveness of an Epilepsy Educational Application for Self-management in Viet Nam: a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05491369
Enrollment
148
Registered
2022-08-08
Start date
2022-09-01
Completion date
2024-06-01
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Self-management, Mobile health application, Effectiveness

Brief 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 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.

Interventions

OTHEREpilepsy application

Nanacara is an epilepsy application which helps people with epilepsy to self-manage their conditions.

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

In an attempt to blind the participants, they will be told there will be two start times for using the app, with randomization to either date. The outcome assessor will not know which group participants are in

Intervention model description

Randomized clinical trial (RCT): parallel, two-arm design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* People with epilepsy diagnosed and treated by neurologists * Smartphone users

Exclusion criteria

* Substance dependence * Suicidality * Limited language proficiency

Design outcomes

Primary

MeasureTime frameDescription
Epilepsy Self-Management Scale (ESMS)3-monthThe 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)3-monthThe 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.

Secondary

MeasureTime frameDescription
PHQ9 (Patient Health Questionnaire scale)3-monthPHQ9 is a self-reported questionnaire to assess depression.
GAD7 (Generalized Anxiety Disorder scale)3-monthAssess generalized anxiety

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026