Clinical trial NCT03583840: Effectiveness of a Web-based Intervention to Promote Health Screening in Men
Official title: Effectiveness of a Web-based Intervention to Promote Health Screening in Men: A Community-based Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mass Screening
Preventive Health Services
Keywords: men's health
internet
telemedicine
mass screening
health behavior
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Leeds Beckett University
name: University of Sheffield
name: The University of New South Wales
First posted: 2018-07-11
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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, 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who have undergone health screening
timeFrame: 1 month post-intervention
measure: Number of participants who have undergone health screening
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Change in intention (months) to undergo health screening
timeFrame: Immediately post-intervention
measure: Change in intention (months) to undergo health screening
timeFrame: 1 month post-intervention
measure: Change in intention (months) to undergo health screening
timeFrame: 3 months post-intervention
measure: Change in knowledge on health screening
timeFrame: Immediately post-intervention
measure: Change in knowledge on health screening
timeFrame: 1 month post-intervention
measure: Change in knowledge on health screening
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: University of Malaya
name: Chirk Jenn Ng, MMed,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.2196/jmir.6.4.e40.
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.
citation: Uhler LM, Perez 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.
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.
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.