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临床试验/NCT04529681
NCT04529681Unknown不适用

Effectiveness of Stroke Riskometer Apps In Improving Awareness of Stroke Risk and Stroke Risk Probability Among Young Adult Population In Kelantan: An App-Based Intervention Study

Ministry of Health, Malaysia1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2020年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
116
试验地点
1
主要终点
Stroke Risk Awareness

研究概览

简要总结

This intervention study using the Stroke Riskometer Apps as health promotion and disease prevention tools for the stroke prevention. Study will specifically target the young adult population (18-50 years old) who are the population at risk for young stroke. The study will determine the effectiveness of Stroke Riskometer Apps by assessing the awareness (knowledge, perception of stroke risk and intention to change behaviours) using the translated ABCD risk questionnaire and stroke risk probability using Stroke Riskometer Apps.

详细描述

This intervention study is non-blinded, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in Kelantan, Malaysia with sample size of 58 each groups. The study will have four points of data collection (for ABCD risk questionnaire) in 6 weeks of intervention study. Primary outcome will be analysed using the Linear Mixed Effect model. Not only the effectiveness of Stroke Riskometer Apps, the investigators also able to get baseline stroke risk among young adult population in Kelantan, Malaysia. However, because of the time and budget limiting, the investigators only able to handle in Kelantan population and within 6 weeks duration.

This study will produce good impact; (a) targeting young adult population in response to young stroke incidence nationally and internationally, (b) tool that the investigators used will be a good starting to health promotion and disease prevention in Malaysia (model of valid and comparable stroke risk calculator, modules that used by Stroke Riskometer Apps), (c) comparing to current practices of non-communicable diseases (NCDs) prevention strategies - may need a practical and new effective strategy especially to catch up the newer generation at risk other than depending on health promotion and disease prevention program and leaflets promotion in health clinics.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All consented young adult (aged 18 - 50 years old) who are Kelantan resident, can understand Malay language and own a smartphone.

排除标准

  • •Non-Malaysian and ever diagnosed of stroke and psychiatric problem.

研究组 & 干预措施

Intervention Group

Experimental

Intervention group will be equipped with Stroke Riskometer Apps and informational leaflets. In the beginning of the study, investigators will guide the participants to download and install the Stroke Riskometer Apps and how to use the application to measure, monitor and self-manage the stroke risk. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week.

干预措施: Informational Leaflets (Other)

Intervention Group

Experimental

Intervention group will be equipped with Stroke Riskometer Apps and informational leaflets. In the beginning of the study, investigators will guide the participants to download and install the Stroke Riskometer Apps and how to use the application to measure, monitor and self-manage the stroke risk. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week.

干预措施: Stroke Riskometer Application (Device)

Control Group

Other

Control group will be given the informational leaflets consist of stroke-related leaflet, CVDs-related leaflet and the healthy eating behaviors. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week.

干预措施: Informational Leaflets (Other)

结局指标

主要结局

Stroke Risk Awareness

时间窗: 6 weeks

The outcome will be measured as stroke risk awareness score. The score will be calculated from the translated and validated 'Attitudes and Beliefs about Cardiovascular Disease (ABCD) Risk Questionnaire' which consists of 26 questions with total score of 80. The awareness score represents domain of knowledge (8 items), perception (12 items) and intention to change (6 items). For the domain knowledge, the type of answer is true/false/don't know while the rest are 4 likert scales; strongly disagree, disagree, agree and strongly agree. The total score will be calculated as percentage and the higher the percentage, the better the awareness of stroke risk. It will be assessed at the earlier of the study, second week, forth week and sixth week. The outcome will be analysed using the Linear Mixed Effect model after adjusting the potential confounder such as sociodemographic (age, gender, ethnicity, marital status) and/or socioeconomic status (education level, income/occupational).

次要结局

  • Body Mass Index (kg/m^2)(6 weeks)
  • Blood Pressure (mmHg)(6 weeks)
  • Stroke Risk Probability(6 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamad Zarudin Bin Mat Said

Principal Investigator

Ministry of Health, Malaysia

研究点 (1)

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