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临床试验/NCT05307484
NCT05307484已完成不适用

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

SingHealth Polyclinics2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Change of knowledge, attitude and practice (KAP) assessment score on dengue fever prevention

研究概览

简要总结

Dengue can be mitigated by both vector control and vaccination. Serious games in healthcare can be used to raise the community awareness of vector control in dengue prevention in a simulated interactive learning environment, by motivating serious game participants to optimise their own performance and influence their behaviour. The results show a specially designed serious game can better engage local residents by raising their awareness in vector control and proactiveness in dengue prevention. At least 8 out of 10 participants were willing to be vaccinated against dengue if they knew of the availability of a safe and effective vaccine.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Randomization sequence was prepared by the bio-statistician who was not involved in the enrollment of the participants. The outcome data was collected via a participant-administered questionnaire on an online secured platform, without contact with the study members. All data were de-identified and the statistical analysis was performed by the bio-statistician, who was blinded to group allocation, only after the completion of enrollment of all participants. The principal investigator was not involved in the enrollment or randomization process of participants in this study.

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Adult who is not able to use a mobile phone due to physical or cognitive impairments.

结局指标

主要结局

Change of knowledge, attitude and practice (KAP) assessment score on dengue fever prevention

时间窗: 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.

次要结局

  • System Usability Scale (SUS) score of serious game(At 2 weeks from start of study (or within 2 weeks after completion of intervention by the serious game group))
  • Change of interest to vaccinate against Dengue(Change from baseline Dengue vaccination interest at 2 weeks (or within 2 weeks after completion of intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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