- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05307484
Effects of a Serious Game on Knowledge, Attitude and Practice in Vector Control and Dengue Prevention Among Adults in Primary Care
Effects of a Serious Game on Knowledge, Attitude and Practice in Vector Control and Dengue Prevention Among Adults in Primary Care: A Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Study design: From March to August 2021, a single-centre randomised controlled trial was conducted to determine the effectiveness of playing a serious game (intervention) in improving the KAP of participants in vector control and dengue prevention compared to those who viewed a dengue prevention website (control).
Study site: This study was conducted at a regional public primary care clinic (Polyclinic) in Sengkang. Sengkang Polyclinic is located in Sengkang Community Hub, which is an amenity centre in Sengkang, within the North-East region of Singapore. Sengkang is also a residential town, which is the second most populous in the region, being home to 244,600 residents in 2019.
Sample size calculation: To determine the effect of serious game in the literacy level of adults in preventing dengue in Singapore, the sample size was computed based on the study by Nurul Akmar Ghani et al, in which the significant difference in mean and standard deviation of knowledge scores were 14.55 (3.09) and 15.41 (2.75) respectively between the compared groups. To obtain a sample size with 95% confidence level and 80% power for this study, a minimum of 182 participants per group was required. With a possible drop out of 10%, the sample size was increased to 200 per group.
Recruitment and consent process: Recruitment posters, containing registration details of the study, were placed within the clinic's premises from March to August 2021. Adults who were interested to join the study voluntarily could approach the clinical research coordinators (CRCs), who would screen them for eligibility, explained the study intent and procedure to them in a designated room within the study site. The CRCs were trained by the principal investigator to provide adequate information and address relevant concerns or queries from the participants prior to the start of this study. The latter were informed about the purpose and content of the study based on the approved participant information sheet. After clarifying their doubts and queries, every eligible participant endorsed their written informed consent before randomization.
Randomization: The randomization sequence was created by the biostatistician using computer generated random numbers in a 1:1 ratio. Random permuted blocks were used to ensure equal number in each group. The randomization sequence was concealed in sequentially numbered, opaque, sealed envelopes by the principal investigator (PI) at the study site, and stored in a secured location that was accessible only by the research assistants. Blinding was not possible for the participants and the CRCs, as the intervention group would be required to download an application into the mobile phone. Both the biostatistician and PI were not involved in the enrolment or randomization process of participants in this study.
Study procedure: The KAP assessment instrument was adapted from a previous study conducted by Nurul Akmar Ghani et al.
Participants in both groups completed the first (baseline) questionnaire via a secured online platform, Form.sg. Form.sg was used to create online questionnaires that capture classified data for this study. The platform does not store participants' response data in its servers and all responses are sent directly to the study team's dedicated email address.
Participants in the intervention group installed a mobile application, 'Sam's Mozzie Adventure' and were instructed to complete the game within 2 weeks.
Participants in the control group accessed the National Environmental Agency 'Stop Dengue' website and were instructed to complete reading the dengue prevention information within 2 weeks.
Both groups completed the second questionnaire, containing the KAP assessment and a question pertaining to individual's interest to vaccinate against dengue, within 2 weeks after the intervention. In addition, participants in the serious game group evaluated the game with the adapted Systems Usability Score.
Analysis: The knowledge, attitude and practice scores varied from 0-16, 0-15, 0-15 respectively, with a maximum score of 46 points. The highest achievement attained by the participants in serious game group were measured by the number of stars awarded in-game, which varied from 0-48 stars. The data were audited and errors were rectified before analyses. Descriptive statistics in terms of frequency (n), percentage (%), mean and standard deviations (SD) were used to express the data. The socio-demographic variables between the two groups were compared using Chi-Square test for categorical variables and independent t-test for continuous variables. Independent t-test was used to compare the baseline, follow up and change in KAP scores between the control and intervention group. Paired t-test was used to determine the difference in scores from baseline and follow up. The Spearman's correlation was used to determine the association between change scores and maximum game stars awarded in the intervention group. SUS score was presented in frequency and percentages. A p-value of less than 0.05 is considered statistically significant. All analyses were performed using IBM SPSS 27.0.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
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Singapore, Singapur, 545025
- SingHealth Polyclinics - Sengkang
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Adult who is visiting Sengkang Polyclinic.
- Able to understand English.
- Has a mobile phone which was compatible with the serious game and willing to download and attempt the serious game.
- Able to complete questionnaires on the online secured platform, Form.sg.
Exclusion Criteria:
- Adult who is not able to use a mobile phone due to physical or cognitive impairments.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Serious game group
Participants in the intervention group installed a mobile application, 'Sam's Mozzie Adventure'.
This is a locally designed serious game which was co-created between SingHealth Polyclinics and AI Innovation Labs (AI2 Labs) Private Limited, specifically for this study.
The principal investigator reviewed existing publicly available information on dengue prevention, including those on the National Environmental Agency (NEA) 'Stop Dengue' website, and provided the relevant content and pedagogical knowledge to the team of app developers from AI2 Labs.
After creating the syllabus, the developers deployed their technological knowledge to integrate the dengue prevention information into the serious game.
The participants were instructed to complete playing this serious game within 2 weeks.
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This is a serious game in the form of a mobile application, designed to educate adults on dengue prevention.
Ostatní jména:
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Aktivní komparátor: Dengue prevention website group
The control group accessed the NEA 'Stop Dengue' website which contained dengue prevention information in the forms of online articles, posters and video.
The participants were instructed to complete reading the online resources within 2 weeks.
|
This is a website containing information regarding dengue prevention.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of knowledge, attitude and practice (KAP) assessment score on dengue fever prevention
Časové okno: Change from baseline KAP score at 2 weeks (or within 2 weeks after completion of intervention)
|
This outcome is measured via a participant-administered questionnaire which was used and validated in previous regional studies. It is divided into 3 sections: (1) knowledge (16 items), (2) attitude (15 items), (3) practice (15 items) in preventing dengue. The minimum and maximum values of this questionnaire are 0 and 46 respectively. A higher score indicates a better outcome. |
Change from baseline KAP score at 2 weeks (or within 2 weeks after completion of intervention)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of interest to vaccinate against Dengue
Časové okno: Change from baseline Dengue vaccination interest at 2 weeks (or within 2 weeks after completion of intervention)
|
This outcome is measured via a participant-administered questionnaire. It consists of 1 section: (1) interest to vaccinate against Dengue (1 item). A higher proportion of participants indicating interest to vaccinate against Dengue indicates a better outcome. |
Change from baseline Dengue vaccination interest at 2 weeks (or within 2 weeks after completion of intervention)
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System Usability Scale (SUS) score of serious game
Časové okno: At 2 weeks from start of study (or within 2 weeks after completion of intervention by the serious game group)
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This outcome is measured via a participant-administered questionnaire. It is modified from the validated SUS template to evaluate the usability of this serious game. The SUS has 10 statements, and a 5-point Likert scale is used to indicate the participant's agreement with the statements. The response of each participants is collated and a standardized formula is applied to calculate the final SUS score. A score above 68 is above average and scores below 68 is below average in terms of system usability. A score of less than 68 indicates that the participants may have less than average user experience with the serious game. |
At 2 weeks from start of study (or within 2 weeks after completion of intervention by the serious game group)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alon Tan, SingHealth Polyclinics
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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