Effectiveness of an Epilepsy Application for Self-management in Viet Nam
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Epilepsy application
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, Self-management, Mobile health application, Effectiveness
Eligibility Criteria
Inclusion Criteria:
- People with epilepsy diagnosed and treated by neurologists
- Smartphone users
Exclusion Criteria:
- Substance dependence
- Suicidality
- Limited language proficiency
Sites / Locations
- Nguyen Tri Phuong HospitalRecruiting
- University Medical Center at Ho Chi Minh CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Application users
Control group
Arm Description
Participants will use application for self-management.
Participants will be in the waiting list which don't use the app.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
PHQ9 (Patient Health Questionnaire scale)
PHQ9 is a self-reported questionnaire to assess depression.
GAD7 (Generalized Anxiety Disorder scale)
Assess generalized anxiety
Full Information
NCT ID
NCT05491369
First Posted
August 4, 2022
Last Updated
March 2, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
1. Study Identification
Unique Protocol Identification Number
NCT05491369
Brief Title
Effectiveness of an Epilepsy Application for Self-management in Viet Nam
Official Title
Effectiveness of an Epilepsy Educational Application for Self-management in Viet Nam: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Self-management, Mobile health application, Effectiveness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial (RCT): parallel, two-arm design
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Application users
Arm Type
Active Comparator
Arm Description
Participants will use application for self-management.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will be in the waiting list which don't use the app.
Intervention Type
Other
Intervention Name(s)
Epilepsy application
Intervention Description
Nanacara is an epilepsy application which helps people with epilepsy to self-manage their conditions.
Primary Outcome Measure Information:
Title
Epilepsy Self-Management Scale (ESMS)
Description
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.
Time Frame
3-month
Title
Quality of Life in Epilepsy Inventory (QOLIE-31)
Description
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.
Time Frame
3-month
Secondary Outcome Measure Information:
Title
PHQ9 (Patient Health Questionnaire scale)
Description
PHQ9 is a self-reported questionnaire to assess depression.
Time Frame
3-month
Title
GAD7 (Generalized Anxiety Disorder scale)
Description
Assess generalized anxiety
Time Frame
3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People with epilepsy diagnosed and treated by neurologists
Smartphone users
Exclusion Criteria:
Substance dependence
Suicidality
Limited language proficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minh-An T Le, Master
Phone
+84903754494
Email
minhanle@ump.edu.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minh-An T Le, Master
Organizational Affiliation
University of Medicine and Pharmacy at HCMC
Official's Role
Study Chair
Facility Information:
Facility Name
Nguyen Tri Phuong Hospital
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh-An T Le, MD
Phone
+84903754494
Email
minhanle@ump.edu.vn
First Name & Middle Initial & Last Name & Degree
Le
Facility Name
University Medical Center at Ho Chi Minh City
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh-An T Le
Phone
+84903754494
Email
minhanle@ump.edu.vn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31837500
Citation
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.
Results Reference
result
PubMed Identifier
32599431
Citation
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.
Results Reference
result
PubMed Identifier
29422360
Citation
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.
Results Reference
result
PubMed Identifier
32092160
Citation
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.
Results Reference
result
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Effectiveness of an Epilepsy Application for Self-management in Viet Nam
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