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

Mass Screening Clinical Trial

— ScreenMen  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03583840
• Other study ID #: RP041A-15HTM
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: October 2019

Study information

• Verified date: July 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Mass Screening
• Preventive Health Services

Intervention

Behavioral:
• ScreenMen website
An educational website that aims to improve evidence-based health screening uptake in men

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (4)

Lead Sponsor	Collaborator
University of Malaya	Leeds Beckett University, The University of New South Wales, University of Sheffield

Country where clinical trial is conducted

Malaysia, 

References & Publications (8)

Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Harper GW, Horvath K, Weiss G, Dittus P. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav. 2015 Oct;19(10):1860-74. doi: 10.1007/s10461-015-1009-y. — View Citation

Evans R, Joseph-Williams N, Edwards A, Newcombe RG, Wright P, Kinnersley P, Griffiths J, Jones M, Williams J, Grol R, Elwyn G. Supporting informed decision making for prostate specific antigen (PSA) testing on the web: an online randomized controlled trial. J Med Internet Res. 2010 Aug 6;12(3):e27. doi: 10.2196/jmir.1305. — View Citation

Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. Epub 2012 Oct 2. — View Citation

Schnall R, Rojas M, Bakken S, Brown W, Carballo-Dieguez A, Carry M, Gelaude D, Mosley JP, Travers J. A user-centered model for designing consumer mobile health (mHealth) applications (apps). J Biomed Inform. 2016 Apr;60:243-51. doi: 10.1016/j.jbi.2016.02.002. Epub 2016 Feb 20. — View Citation

Uhler LM, Pérez Figueroa RE, Dickson M, McCullagh L, Kushniruk A, Monkman H, Witteman HO, Hajizadeh N. InformedTogether: Usability Evaluation of a Web-Based Decision Aid to Facilitate Shared Advance Care Planning for Severe Chronic Obstructive Pulmonary Disease. JMIR Hum Factors. 2015 Feb 25;2(1):e2. doi: 10.2196/humanfactors.3842. — View Citation

Verkuyl M, Atack L, Mastrilli P, Romaniuk D. Virtual gaming to develop students' pediatric nursing skills: A usability test. Nurse Educ Today. 2016 Nov;46:81-85. doi: 10.1016/j.nedt.2016.08.024. Epub 2016 Aug 25. — View Citation

Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change outcomes. J Med Internet Res. 2004 Nov 10;6(4):e40. Review. — View Citation

Young SD, Cumberland WG, Lee SJ, Jaganath D, Szekeres G, Coates T. Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial. Ann Intern Med. 2013 Sep 3;159(5):318-24. doi: 10.7326/0003-4819-159-5-201309030-00005. — View Citation

Outcome

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