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

NCT ID: NCT05491369

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-06-01

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Application users

Participants will use application for self-management.

Group Type: ACTIVE_COMPARATOR

Epilepsy application

Intervention Type: OTHER

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

Control group

Participants will be in the waiting list which don't use the app.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Epilepsy application

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Substance dependence
• Suicidality
• Limited language proficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Minh-An Thuy Le

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minh-An T Le, Master

Role: STUDY_CHAIR

University of Medicine and Pharmacy at HCMC

Locations

Nguyen Tri Phuong Hospital

Ho Chi Minh City, , Vietnam

University Medical Center at Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Countries

Vietnam

References

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.

Reference Type: RESULT

PMID: 31837500 (View on PubMed)

Pandey 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.

Reference Type: RESULT

PMID: 32599431 (View on PubMed)

Le 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.

Reference Type: RESULT

PMID: 29422360 (View on PubMed)

Si 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.

Reference Type: RESULT

PMID: 32092160 (View on PubMed)

Other Identifiers

22416 - ĐHYD

Identifier Type: -

Identifier Source: org_study_id