- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07774910
Reminder-based Educational Mobile Intervention for for Maternal Oral Health Literacy and Preschoolers' Dental Health (REMIND)
The Effectiveness of a Notification- and Reminder-Based Educational Application in Improving Maternal Oral Health Literacy and the Dental Health Status of Preschool Children in Pancoran Mas
The goal of this clinical trial is to determine the effectiveness of educational application based on notification and reminder in improving maternal oral health literacy and the dental and dental health status of preschool children among mother-preschool child pairs (children aged <7 years) in Pancoran Mas, Depok City.
The primary research questions to be addressed in the main trial are:
- Does the application group improve mothers' oral health literacy (measured using the REALD-30 questionnaire) more than the printed booklet group?
- Does the application group improve children's oral health status, as measured by oral hygiene (Debris Index-Simplified [DI-S]) and gingival condition (modified Gingival Index [mGI]), more than the printed booklet group?
- What is the level of usability (ease of use) of the application as perceived by mothers who use it?
The researchers will compare a group of mothers who receive education through the application with a group of mothers who receive education through a printed booklet to determine whether the application produces greater improvements in maternal oral health literacy and children's oral health outcomes.
Participants will be asked to:
- Complete the REALD-30 questionnaire at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments.
- Accompany their children for DI-S and mGI examinations at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments, conducted by a calibrated dentist.
- Receive and study dental health education materials delivered progressively, one chapter per week, through either the application (intervention group) or a printed booklet (control group). Subsequent chapters will be unlocked in the following week.
- Complete a daily checklist documenting their child's tooth-brushing activities every morning and evening throughout the study period.
- For participants in the application group only: receive daily notifications/reminders and personalized educational messages (based on quiz scores and checklist compliance levels), and complete the Mobile App Usability Questionnaire (MAUQ) at the end of the program.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Study Design and Setting:
This study employed a quasi-experimental design with a pretest-posttest non-equivalent control group approach and was conducted in parallel between the intervention and control groups in seven preschool in Pancoran Mas , Depok City, Indonesia, between July and December 2024. Participant allocation was non-randomized. The sample size was calculated using the analytical formula for comparing numerical between two independent groups. The final sample size was determined to be 100 participants in each group, yielding a total analytical sample of 200 mother-child pairs. Participants were recruited through a non-probability purposive sampling method at the village and school levels.
Intervention:
The study compared two educational media containing identical content on tooth anatomy, oral hygiene practices, oral diseases, and the development of dental caries (four chapters):
- Application (Peri Bugi): An interactive mHealth application featuring daily notifications and reminders, supplemented with a rule-based AI system that personalizes the frequency of educational messages according to quiz performance and compliance with the toothbrushing checklist.
- Booklet: A printed text-based educational material designed for self-directed learning.
Study Protocol:
- Application Development. The development process included conceptual planning (objectives, target users, framework, and REALD-30-based content), UI/UX wireframe design, development of the four educational chapters, and prototype creation.
- Expert Evaluation. Four experts (two computer science experts and two experts/master's students in community dentistry) evaluated the feasibility and usability of the prototype online via Zoom using the System Usability Scale (SUS) questionnaire. The evaluation results were used to revise and improve the application.
- Pilot Study. Twenty end users (10 in the application group and 10 in the booklet group) tested the intervention over a two-week period. Baseline assessments included the REALD-30 questionnaire for mothers and the Oral Hygiene Index-Simplified (OHI-S) for children.
Main Effectiveness Trial
- Baseline Assessment: All participants completed a pretest to assess baseline conditions. Mothers completed the REALD-30 questionnaire, while children underwent DI-S and mGI examinations performed by calibrated dentists.
- Intervention Period: Participants in the intervention group used the Peri Bugi application, whereas those in the control group used the printed booklet. Educational materials were delivered progressively, with one chapter released each week over a four-week period. Participants were also required to complete morning and evening toothbrushing checklists. Coordination regarding chapter release schedules was conducted through WhatsApp groups.
- Post-Intervention Assessment: One month after baseline, all participants completed a posttest involving the same assessments administered at baseline. In addition, participants in the intervention group completed an application usability assessment.
Assessment Tools:
Oral Health Literacy: The REALD-30 questionnaire (Lee et al., 2007) was used to assess mothers' oral health literacy through recognition of dental terminology. Scores were converted to a 0-100 scale, with higher scores indicating better oral health literacy. The questionnaire was administered at both pretest and posttest.
Children's Oral Health Status: The Debris Index-Simplified (DI-S) was used to assess oral hygiene status, while the Modified Gingival Index (mGI) was used to evaluate gingival health. Both measurements were conducted at pretest and posttest by calibrated dentists.
Application Usability: The Mobile Health App Usability Questionnaire (MAUQ) (Zhou et al., 2019), consisting of three subscales and a 7-point Likert scale, was administered to participants in the intervention group at posttest. Lower scores indicated better usability according to the scoring system applied in this study.
Assessment Tools:
- Oral Health Literacy: The REALD-30 questionnaire (Lee et al., 2007) was used to assess mothers' oral health literacy through recognition of dental terminology. Scores were converted to a 0-100 scale, with higher scores indicating better oral health literacy. The questionnaire was administered at both pretest and posttest.
- Children's Oral Health Status: The Debris Index-Simplified (DI-S) was used to assess oral hygiene status, while the Modified Gingival Index (mGI) was used to evaluate gingival health. Both measurements were conducted at pretest and posttest by calibrated dentists.
- Application Usability: The Mobile Health App Usability Questionnaire (MAUQ) (Zhou et al., 2019), consisting of three subscales and a 7-point Likert scale, was administered to participants in the intervention group at posttest. Higher scores indicated better usability according to the scoring system applied in this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
West Java
-
Depok, West Java, Indonesien
- Seven preschools in Pancoran Mas
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Mothers with a child aged 3-7 years (preschool-aged child).
- Mothers who own a smartphone and are able to download and install applications.
- Mothers who have internet access and actively use the internet.
- Mothers who are willing and cooperative to participate in the study from enrollment until study completion.
- Preschool children aged 3-7 years.
- Children enrolled in a preschool located in Pancoran Mas, Depok City.
Exclusion Criteria:
- Mothers who were unwilling to sign the informed consent form.
- Mothers or children with physical or mental disabilities (e.g., Down syndrome, hearing impairment, visual impairment, cerebral palsy, or other developmental or physical disabilities).
- Children with congenital diseases or congenital anomalies.
- Children with systemic diseases, such as congenital heart disease, epilepsy, thalassemia, hemophilia, or other systemic medical conditions.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention Group (Peri Bugi Mobile Application)
Mothers in this group received oral health education through the Peri Bugi mHealth application, a notification- and reminder-based platform equipped with a rule-based AI system that personalized the frequency of educational messages based on quiz scores and compliance with the toothbrushing checklist.
Educational materials consisting of four chapters were delivered progressively, with one chapter released each week over a four-week period.
In addition, participants received toothbrushing reminder notifications at 6:30 a.m. and 8:00 p.m.
|
Peri Bugi is an mHealth-based oral health education application developed for Android and iOS devices.
The application comprises five main features: Literacy (a four-chapter flipbook containing oral health educational content), Quiz, Toothbrushing Song, Toothbrushing Checklist, and Settings.
It provides daily reminder notifications and utilizes a rule-based artificial intelligence (AI) system to personalize dental health education messages based on users' quiz performance and adherence to the toothbrushing checklist.
|
|
Aktiver Komparator: Control Group (Printed Booklet)
Mothers in the control group received oral health education through a printed booklet containing content equivalent to that provided in the application.
The educational materials, consisting of four chapters, were delivered progressively, with one chapter provided each week over a four-week period for self-directed learning.
|
A printed text-based oral health education booklet comprising four chapters with content equivalent to that provided in the Peri Bugi application.
The booklet was intended for self-directed learning and did not incorporate any notification, reminder, or personalized educational messaging features
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maternal Oral Health Literacy Score (REALD-30 Questionnaire)
Zeitfenster: Baseline (pretest) and 1 month post-intervention (posttest)
|
Change in mothers' oral health literacy, measured using the Rapid Estimation of Adult Literacy in Dentistry (REALD-30) questionnaire.
Scores range from 0 to 30, with each correctly recognized dental term scored as 1 and each incorrectly recognized term scored as 0. Higher scores indicate better oral health literacy.
Changes in scores are assessed by comparing pretest and posttest measurements.
|
Baseline (pretest) and 1 month post-intervention (posttest)
|
|
Children's Oral Hygiene Status (DI-S)
Zeitfenster: Baseline (pretest) and 1 month post-intervention (posttest)
|
Change in the oral hygiene status of preschool children, measured using the Debris Index-Simplified (DI-S) based on the extent of soft debris present on the surfaces of index teeth (score range: 0-3 per tooth surface).
Lower scores indicate better oral hygiene.
Examinations are performed by calibrated dentists.
Changes are assessed by comparing pretest and posttest measurements.
|
Baseline (pretest) and 1 month post-intervention (posttest)
|
|
Children's Gingival Health Status (m-GI)
Zeitfenster: Baseline (pretest) and 1 month post-intervention (posttest)
|
Change in the gingival health status of preschool children, measured using the Modified Gingival Index (mGI) based on the severity of gingival inflammation.
Lower scores indicate healthier gingival conditions.
Examinations are conducted by calibrated dentists.
Changes are assessed by comparing pretest and posttest measurements.
|
Baseline (pretest) and 1 month post-intervention (posttest)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Application Usability Score (MAUQ)
Zeitfenster: 1 month post-intervention (posttest)
|
Mothers' perceptions of the usefulness and ease of use of the Peri Bugi application, measured using the Mobile Health App Usability Questionnaire (MAUQ).
The MAUQ consists of three subscales: ease of use and satisfaction, system information arrangement, and efficiency, using a 7-point Likert scale.
Lower scores indicate better usability according to the scoring system used in this study.
This outcome is assessed only among participants in the intervention group.
|
1 month post-intervention (posttest)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Risqa Rina Darwita, Prof., Indonesia University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
- Shirmohammadi M, Razeghi S, Shamshiri AR, Mohebbi SZ. Impact of smartphone application usage by mothers in improving oral health and its determinants in early childhood: a randomised controlled trial in a paediatric dental setting. Eur Arch Paediatr Dent. 2022 Aug;23(4):629-639. doi: 10.1007/s40368-022-00731-9. Epub 2022 Jul 16.
- Lee JY, Rozier RG, Lee SY, Bender D, Ruiz RE. Development of a word recognition instrument to test health literacy in dentistry: the REALD-30--a brief communication. J Public Health Dent. 2007 Spring;67(2):94-8. doi: 10.1111/j.1752-7325.2007.00021.x.
- Lozoya CJS, Giblin-Scanlon L, Boyd LD, Nolen S, Vineyard J. Influence of a Smartphone Application on the Oral Health Practices and Behaviors of Parents of Preschool Children. J Dent Hyg. 2019 Oct;93(5):6-14.
- Nolen SL, Giblin-Scanlon LJ, Boyd LD, Rainchuso L. Development and Testing of a Smartphone Application Prototype for Oral Health Promotion. J Dent Hyg. 2018 Apr;92(2):6-14.
- Wu K, Yin W, Liang X, Zou L, Yang Z. The influence of parents' oral health literacy and behavior on oral health of preschool children aged 3-6 years- evidence from China. BMC Oral Health. 2024 Nov 28;24(1):1445. doi: 10.1186/s12903-024-05213-6.
- Adil AH, Eusufzai SZ, Kamruddin A, Wan Ahmad WMA, Jamayet NB, Karobari MI, Alam MK. Assessment of Parents' Oral Health Literacy and Its Association with Caries Experience of Their Preschool Children. Children (Basel). 2020 Aug 18;7(8):101. doi: 10.3390/children7080101.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 61/Ethical Approval/FKGUI/IX/2
- PKS 149/UN2.RST/HKP.05.00/2025 (Andere Zuschuss-/Finanzierungsnummer: Universitas Indonesia PUTI Q1 Equity Grant 2025)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .