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Effectiveness of a Web-based Intervention to Promote Health Screening in Men (ScreenMen)

2019年7月21日 更新者:Professor Ng Chirk Jenn、University of Malaya

Effectiveness of a Web-based Intervention to Promote Health Screening in Men: A Community-based Randomised Controlled Trial

Health screening is proven to be effective in reducing morbidity, death and healthcare cost. However, the uptake of health screening is low particularly in men. In the earlier phase of this project, a web-based intervention (ScreenMen) to increase health screening uptake in men was developed based on theories, evidence and user needs. It was tested with experts and users for its utility and usability.

In this phase, a randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of ScreenMen in improving health screening knowledge & uptake in men. Healthy men, who have not gone for screening in the past 1 year will be recruited via Facebook to participate in this RCT. The participants will be randomised to receive or not to receive ScreenMen. Knowledge and intention to screen will be measured immediately post-intervention. All participants will be followed up at 1 month and 3 months to measure knowledge, intention and actual uptake of screening.

研究概览

详细说明

The uptake of health screening is low in Malaysia, particularly in men. There is a need to increase health screening uptake in men as this will not just save healthcare cost and increase national productivity in the long run but also improve the quality of life of men and their family.

There were many interventions to increase health screening uptake in men which have been identified in the systematic review conducted in the earlier phase of this study. However, there is a lack of ICT-based intervention promoting health screening. The few existing ICT based interventions only focus on screening on a specific disease such as HIV or prostate cancer.(1-3) There was no ICT-based intervention which aimed to increase the uptake of comprehensive health screening.

Studies have shown that ICT-based interventions are effective in improving health behaviour.(4) On top of that, there is a high number of internet accessibility and smartphone ownership in Malaysia, which provides a good platform to promote health screening in men. Thus, ScreenMen, a web-based intervention was developed based on theories, evidence and users' needs. It was tested with experts and users in terms of its utility and usability. (5-7)

To the best of our knowledge, ScreenMen is the first mobile-responsive web-based intervention that promotes comprehensive evidence-based health screening in men. It aims to educate men about screening and empowers them to take charge of their health including undergoing regular health screening. Apart from encouraging health screening, ScreenMen provides advice to men about the recommended health screening they should undergo based on their health risks and educates them to avoid non-evidence-based screening.

Before being launched to the public, a randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of ScreenMen in improving knowledge on screening, intention to screen and the actual uptake of screening. Process evaluation will also be conducted to identify the components that work in improving health screening uptake and resolve any implementation issues of ScreenMen.

研究类型

介入性

注册 (预期的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Kuala Lumpur、马来西亚
        • University of Malaya

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion criteria:

  • Male
  • 18 year old and above
  • Own a smart phone

Exclusion criteria:

  • Undergone health screening within the past 1 year
  • Diagnosed with any of the following diseases (Hypertension, Diabetes, High cholesterol, Colorectal cancer, Lung cancer, Hepatitis B, Hepatitis C, HIV

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control group
Participants who will not be directed to the ScreenMen website
实验性的:Intervention group
Participants who will be directed to the ScreenMen website
An educational website that aims to improve evidence-based health screening uptake in men

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants who have undergone health screening
大体时间:1 month post-intervention

A questionnaire will be sent to the participants 1 month after using the intervention (ScreenMen web) to assess whether they have undergone health screening.

The number of participants who have undergone health screening will be divided over the total number of participants in this study to obtain the proportion and according to study arm.

Uptake at 1 month Intervention: %= n / N *100%; Control: %= n / N *100%

1 month post-intervention
Number of participants who have undergone health screening
大体时间:3 months post-intervention

Participants who reported that they have not undergone health screening during the 1-month follow up will be followed up at 3-month. They will be asked whether they have undergone health screening up to this stage.

The number of participants who have undergone health screening (including those from 1-month follow up) will be divided over the total number of participants in this study to obtain the proportion and according to study arm.

Uptake at 3 month (including those reported yes in 1-month follow up) Intervention: %= n / N *100%; Control: %= n / N *100%

3 months post-intervention

次要结果测量

结果测量
措施说明
大体时间
Change in intention (months) to undergo health screening
大体时间:Immediately post-intervention

Immediately after using the ScreenMen web, participants will be asked when do they intend to undergo health screening. They will be asked in terms of 'in the next __ month(s)'.

The same question has been asked pre-intervention. The change in the 'month(s)' will be calculated. This will be averaged and compared between the intervention and control group.

Change in intention to screen (months) immediately post-intervention = pre-intervention intention to screen (months) - post-intervention intention to screen (months)

Comparison between the change in intention to screen (months) [immediate] for intervention arm and change in intention to screen (months) [immediate] for control arm will be done.

Immediately post-intervention
Change in intention (months) to undergo health screening
大体时间:1 month post-intervention

One month after using the ScreenMen web, participants will be followed up and asked if they have undergone health screening. If not, they will be asked when do they intend to undergo health screening. They will be asked in terms of 'in the next __ month(s)'.

Change in intention to screen will be calculated based on their immediate intention to screen after intervention

Comparison between the change in intention to screen (months) [1-month] for intervention arm and change in intention to screen (months) [1-month] for control arm will be done.

The aim of this is to evaluate the long-term effect of the intervention, whether it is sustained or diminished.

1 month post-intervention
Change in intention (months) to undergo health screening
大体时间:3 months post-intervention

Participants who have not undergone screening will be followed up again at 3-month and asked if they have undergone health screening. If not, they will be asked when do they intend to undergo health screening. They will be asked in terms of 'in the next __ month(s)'.

Change in intention to screen will be calculated based on their immediate intention to screen after intervention

Comparison between the change in intention to screen (months) [3-month] for intervention arm and change in intention to screen (months) [3-month] for control arm will be done.

The aim of this is to evaluate the long-term effect of the intervention, whether it is sustained or diminished.

3 months post-intervention
Change in knowledge on health screening
大体时间:Immediately post-intervention

Immediately after using the ScreenMen web, participants will be asked to answer a validated questionnaire on health screening. The score will be calculated by calculating the number of correctly answered questions over the total number of questions. Knowledge Score (post-intervention - immediate) = n/N

The participants have filled the same questionnaire pre-intervention. Change of knowledge score will be calculated as shown below:

Change in Knowledge Score = Knowledge Score (post-intervention - immediate) - Knowledge Score (pre-intervention)

The Change in Knowledge Score will be compared between intervention and control group.

Immediately post-intervention
Change in knowledge on health screening
大体时间:1 month post-intervention

One month after using the ScreenMen web, participants will be followed up and asked to fill up the same health screening questionnaire. The score will be calculated by calculating the number of correctly answered questions over the total number of questions. Knowledge Score (post-intervention - immediate) = n/N

Change of knowledge score from immediate to 1 month post-intervention will be calculated as shown below:

Change in Knowledge Score = Knowledge Score (1 month post-intervention) - Knowledge Score (immediately post-intervention)

The Change in Knowledge Score from immediate to 1 month post-intervention will be compared between intervention and control group.

The aim of this is to evaluate the long-term effect of the intervention, whether the participants' knowledge on health screening is sustained or diminished.

1 month post-intervention
Change in knowledge on health screening
大体时间:3 months post-intervention

Three months after using the ScreenMen web, participants will be followed up and asked to fill up the same health screening questionnaire. The score will be calculated by calculating the number of correctly answered questions over the total number of questions. Knowledge Score (post-intervention - immediate) = n/N

Change of knowledge score from immediate to 3 months post-intervention will be calculated as shown below:

Change in Knowledge Score = Knowledge Score (3 months post-intervention) - Knowledge Score (immediately post-intervention)

The Change in Knowledge Score from immediate to 1 months post-intervention will be compared between intervention and control group.

The aim of this is to evaluate the long-term effect of the intervention, whether the participants' knowledge on health screening is sustained or diminished.

3 months post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Chirk Jenn Ng, MMed,PhD、University of Malaya

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月27日

初级完成 (预期的)

2019年9月1日

研究完成 (预期的)

2019年10月1日

研究注册日期

首次提交

2018年6月18日

首先提交符合 QC 标准的

2018年6月28日

首次发布 (实际的)

2018年7月11日

研究记录更新

最后更新发布 (实际的)

2019年7月23日

上次提交的符合 QC 标准的更新

2019年7月21日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • RP041A-15HTM

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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