Mass Screening Clinical Trial
— ScreenMenOfficial title:
Effectiveness of a Web-based Intervention to Promote Health Screening in Men: A Community-based Randomised Controlled Trial
Verified date | July 2019 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 220 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | University of Malaya | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya | Leeds Beckett University, The University of New South Wales, University of Sheffield |
Malaysia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who have undergone health screening | 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 | |
Primary | Number of participants who have undergone health screening | 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 | |
Secondary | Change in intention (months) to undergo health screening | 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 | |
Secondary | Change in intention (months) to undergo health screening | 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 | |
Secondary | Change in intention (months) to undergo health screening | 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 | |
Secondary | Change in knowledge on health screening | 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 | |
Secondary | Change in knowledge on health screening | 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 | |
Secondary | Change in knowledge on health screening | 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 |
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