]>
IRCT20250901067065N1 IRCT 2025-10-03 Hamedan University of Medical Sciences The effect of gamification mobile health application on medication adherence The effect of gamification mobile health application based on Pender’s health promotion model on medication adherence in adolescents with epilepsy 2025-09-09 anticipated 92 Complete https://irct.ir/trial/85918 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A random number will be generated for each participant using the RAND function in Excel, and participants will be sorted in ascending order based on these numbers. A simple lottery will then be conducted to determine which group (intervention or control) will be allocated to the first half of the list. Accordingly, the first 46 participants will be assigned to the selected group, and the remaining 46 to the other group. The allocation will be performed after all participants have been enrolled in the study to ensure allocation concealment. N/A Epilepsy. Intervention 1: Intervention group: The designed gamification application, along with installation instructions and user guidelines, will be provided in the form of educational content via a virtual channel. Adolescents will be asked to install the application on their smartphones and use it in their daily routine for a period of one month (the intervention duration).The gamification content was developed based on the determinants of medication adherence and according to the constructs of Pender’s Health Promotion Model. The application consists of five icons: Education, Quiz, Reminder, Forgetfulness, and Chat. Education and Quize section: Includes educational videos related to medication adherence. Adolescents are required to watch these videos every other day and participate in the related quiz embedded in the Quiz section. Successful completion of each quiz will unlock the next level in the game. Participants are allowed unlimited attempts until they pass the quiz. Each quiz contains several questions with a pre-defined and limited response time. Upon passing each quiz, the adolescent receives a “badge” within the game. Reminder section: Medication reminder alarms will be set for each participant by the researcher via the server, based on the physician’s prescription. After each reminder is activated, the adolescent has 60 seconds to take the medication and confirm intake through the notification system. Each confirmation of medication intake is rewarded with one coin as a game "point". Forgetfulness section: Displays a forgetfulness log, where the number of missed doses (i.e., failure to confirm medication intake after an alarm) is automatically recorded, providing a visual overview of the adolescent’s medication-taking behavior. Chat section: Allows adolescents to share their forgetfulness logs with peers and communicate directly with the researcher via a chat box to ask questions or report problems. At the end of the intervention, prizes will be awarded to the top three adolescents who earn the highest number of badges and points. All user activities within the application will be monitored and controlled by the researcher through the server. It should be noted that none of the gamification features interfere with adolescents’ school, sleep, or daily activities. During the intervention period, the experimental group will also continue to receive routine care and medical visits. Parents will have access to the virtual channel and the application and sufficient opportunity to supervise their child’s participation. participants completed the questionnaires at the end of the intervention period. Intervention 2: Control group: During the intervention period, in the related virtual channel, simultaneously with the Intervention Group, only questionnaires will be provided for completion, along with information on how to complete them and reminder notifications to complete the questionnaires. Data will be recorded and collected on the investigators’ server.The Control Group, during the intervention period, will continue to receive usual care and routine visits.At the end of the study, to adhere to ethical considerations, the gamification content, together with installation and usage instructions, will be uploaded to their related virtual channel and responses to their questions will be provided.The duration and method of implementing gamification will be the same as for the Intervention Group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Hedieh Sadat Hosseini
No. 19, 2nd Fl., Sadeghiyeh Aly., Shiva Aly., 12-Meter Avicenna St., Taleghani St.
Hamedan Iran (Islamic Republic of) 6515769548 +98 81 3826 2756 hs.hoseini@edu.umsha.ac.ir Hamedan University of Medical Sciences scientific Fatemeh Cheraghi
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Pajoohesh Square, Hamadan
Hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۶۹۸ +98 81 3838 0535 f_cheraghi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of epilepsy based on medical record Minimum of 6 months elapsed since definitive epilepsy diagnosis, as documented in the medical record Uniform medication regimen according to the medical record Age range: 11 to 20 years Medication adherence: poor to moderate, assessed by adherence questionnaire Willingness of the adolescent and the legal guardian to participate and cooperate in the study Ability to use the participant’s own smartphone (Android OS) for study procedures Access to the Internet 11 years 20 years Both Use of medications that affect the nervous system, excluding antiseizure medication regimen Presence of a significant developmental disorder (e.g., autism spectrum disorders or intellectual disability) Presence of comorbidity (e.g., diabetes, etc.) Presence of serious psychiatric disorders (e.g., depression, anxiety disorders, attention deficit hyperactivity disorder) with confirmation by a psychiatrist History of acute incidents leading to physical or psychological problems within the past month G40 Epilepsy and recurrent seizures Behavior Behavior Intervention group: The designed gamification application, along with installation instructions and user guidelines, will be provided in the form of educational content via a virtual channel. Adolescents will be asked to install the application on their smartphones and use it in their daily routine for a period of one month (the intervention duration).The gamification content was developed based on the determinants of medication adherence and according to the constructs of Pender’s Health Promotion Model. The application consists of five icons: Education, Quiz, Reminder, Forgetfulness, and Chat. Education and Quize section: Includes educational videos related to medication adherence. Adolescents are required to watch these videos every other day and participate in the related quiz embedded in the Quiz section. Successful completion of each quiz will unlock the next level in the game. Participants are allowed unlimited attempts until they pass the quiz. Each quiz contains several questions with a pre-defined and limited response time. Upon passing each quiz, the adolescent receives a “badge” within the game. Reminder section: Medication reminder alarms will be set for each participant by the researcher via the server, based on the physician’s prescription. After each reminder is activated, the adolescent has 60 seconds to take the medication and confirm intake through the notification system. Each confirmation of medication intake is rewarded with one coin as a game "point". Forgetfulness section: Displays a forgetfulness log, where the number of missed doses (i.e., failure to confirm medication intake after an alarm) is automatically recorded, providing a visual overview of the adolescent’s medication-taking behavior. Chat section: Allows adolescents to share their forgetfulness logs with peers and communicate directly with the researcher via a chat box to ask questions or report problems. At the end of the intervention, prizes will be awarded to the top three adolescents who earn the highest number of badges and points. All user activities within the application will be monitored and controlled by the researcher through the server. It should be noted that none of the gamification features interfere with adolescents’ school, sleep, or daily activities. During the intervention period, the experimental group will also continue to receive routine care and medical visits. Parents will have access to the virtual channel and the application and sufficient opportunity to supervise their child’s participation. participants completed the questionnaires at the end of the intervention period. Control group: During the intervention period, in the related virtual channel, simultaneously with the Intervention Group, only questionnaires will be provided for completion, along with information on how to complete them and reminder notifications to complete the questionnaires. Data will be recorded and collected on the investigators’ server.The Control Group, during the intervention period, will continue to receive usual care and routine visits.At the end of the study, to adhere to ethical considerations, the gamification content, together with installation and usage instructions, will be uploaded to their related virtual channel and responses to their questions will be provided.The duration and method of implementing gamification will be the same as for the Intervention Group. Medication adherence score on the Pediatrics Medication Adherence Scale (PMAS) by Bayraktar. Timepoint: Baseline (pre-intervention) and at 1 and 2 months after the initiation of gamification. Method of measurement: Pediatrics Medication Adherence Scale (PMAS) by Bayraktar. Medication beliefs score on the Beliefs about medication questionnaire-Specific (BMQ-Specific) by Horne. Timepoint: Baseline (pre-intervention) and at 1 and 2 months after the initiation of gamification. Method of measurement: Beliefs about medication questionnaire-Specific (BMQ-Specific) by Horne. Medication barriers score on the Adolescent Medication Barriers Scales (AMBS) by Simons. Timepoint: Baseline (pre-intervention) and at 1 and 2 months after the initiation of gamification. Method of measurement: Adolescent Medication Barriers Scales (AMBS) by Simons. Self-efficacy score for appropriate medication use on the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) by Risser. Timepoint: Baseline (pre-intervention) and at 1 and 2 months after the initiation of gamification. Method of measurement: Self-Efficacy for Appropriate Medication Use Scale (SEAMS) by Risser. Hamedan University of Medical Sciences Approved 2025-08-30 Ethics committee of Hamadan University of Medical Sciences Deputy of Research and Technolog, Central Headquarters, Hamadan University of Medical Sciences, 4th Fl., Shahid Fahmideh Blvd., Hamadan, Iran., Hamadan Hamadan Iran (Islamic Republic of)