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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Other: Epilepsy application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with epilepsy diagnosed and treated by neurologists Smartphone users Exclusion Criteria: Substance dependence Suicidality Limited language proficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial (RCT): parallel, two-arm design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Application users<br>Participants will use application for self-management. | Other: Epilepsy application<br>* Nanacara is an epilepsy application which helps people with epilepsy to self-manage their conditions.<br>|
| No Intervention: Control group<br>Participants will be in the waiting list which don't use the app. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ9 (Patient Health Questionnaire scale) | PHQ9 is a self-reported questionnaire to assess depression. | 3-month | 
| GAD7 (Generalized Anxiety Disorder scale) | Assess generalized anxiety | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Self-management, Mobile health application, Effectiveness