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

NCT ID: NCT03583840

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Mass Screening Preventive Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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.

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.

Study Groups

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Control group

Participants who will not be directed to the ScreenMen website

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Participants who will be directed to the ScreenMen website

Group Type EXPERIMENTAL

ScreenMen website

Intervention Type BEHAVIORAL

An educational website that aims to improve evidence-based health screening uptake in men

Interventions

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ScreenMen website

An educational website that aims to improve evidence-based health screening uptake in men

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Leeds Beckett University

OTHER

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Professor Ng Chirk Jenn

Professor Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chirk Jenn Ng, MMed,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University of Malaya

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 25638038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20693148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23071551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15631964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26903153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27025896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27614548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24026317 (View on PubMed)

Other Identifiers

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RP041A-15HTM

Identifier Type: -

Identifier Source: org_study_id

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