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

NCT05491369 | Completed DMC

• 1 other identifier: 22416 - ĐHYD
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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

Conditions

Epilepsy

Keywords

Epilepsy; Self-management; Mobile health application; Effectiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PHQ9 (Patient Health Questionnaire scale)

  3-month

• GAD7 (Generalized Anxiety Disorder scale)

  3-month

Study Arms (2)

Application users

ACTIVE COMPARATOR

Participants will use application for self-management.

Other: Epilepsy application

Control group

NO INTERVENTION

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

Interventions

Epilepsy application OTHER

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

Application users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Substance dependence
• Suicidality
• Limited language proficiency

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (2)

Nguyen Tri Phuong Hospital

Ho Chi Minh City, 700000, Vietnam

Location

University Medical Center at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 31837500 RESULT

• 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.

  PMID: 32599431 RESULT

• 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.

  PMID: 29422360 RESULT

• 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.

  PMID: 32092160 RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Minh-An T Le, Master

  University of Medicine and Pharmacy at HCMC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: September 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 1, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)