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

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ClinicalTrials.gov Identifier: NCT03583840
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
Leeds Beckett University
University of Sheffield
The University of New South Wales
Information provided by (Responsible Party):
Professor Ng Chirk Jenn, University of Malaya

Brief Summary:

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 from a banking institution, who have not gone for screening in the past 1 year will be recruited 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.


Condition or disease Intervention/treatment Phase
Mass Screening Preventive Health Services Behavioral: ScreenMen website Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

It is not possible to blind the participants as the intervention is a website. Participants in the intervention arm will need to go through the website and will know its contents while participants in the control arm will not. Participants in the intervention arm will be given a code which only allows one-time access to the website. This is done to avoid contamination to the control group.

There is no care provider in this study as the intervention is delivered via a website.

The assignment of intervention or control arm to the participants will be done automatically by the website. After signing the consent form, participants will enter a website which will randomise them to either intervention or control arm. The investigators do not play a role in this.

The outcome assessment only involves the participants answering a questionnaire themselves. No Outcome Assessor is required to assess any outcome from the participants.

Primary Purpose: Screening
Official Title: Effectiveness of a Web-based Intervention to Promote Health Screening in Men: A Community-based Randomised Controlled Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
No Intervention: Control group
Participants which are not given the link to the ScreenMen website
Experimental: Intervention group
Participants will be given the link to the ScreenMen website
Behavioral: ScreenMen website
An educational website that aims to improve evidence-based health screening uptake in men




Primary Outcome Measures :
  1. Number of participants who have undergone health screening [ Time Frame: 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%


  2. Number of participants who have undergone health screening [ Time Frame: 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%



Secondary Outcome Measures :
  1. Change in intention (months) to undergo health screening [ Time Frame: 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.


  2. Change in intention (months) to undergo health screening [ Time Frame: 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.


  3. Change in intention (months) to undergo health screening [ Time Frame: 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.


  4. Change in knowledge on health screening [ Time Frame: 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.


  5. Change in knowledge on health screening [ Time Frame: 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.


  6. Change in knowledge on health screening [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Male
  • 18 year old and above
  • Working in a bank institution
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583840


Contacts
Contact: Chin Hai Teo, BSc +60179192669 teoch@um.edu.my

Sponsors and Collaborators
University of Malaya
Leeds Beckett University
University of Sheffield
The University of New South Wales
Investigators
Principal Investigator: Chirk Jenn Ng, MMed,PhD University of Malaya

Publications:

Responsible Party: Professor Ng Chirk Jenn, Professor Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT03583840     History of Changes
Other Study ID Numbers: RP041A-15HTM
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Ng Chirk Jenn, University of Malaya:
men's health
internet
telemedicine
mass screening
health behavior