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

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



Sponsors


Source

University of Malaya

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Not yet recruiting

Start Date

2018-07-01

Completion Date

2018-12-01

Primary Completion Date

2018-09-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Number of participants who have undergone health screening
1 month post-intervention
Number of participants who have undergone health screening
3 months post-intervention

Secondary Outcome

Measure

Time Frame

Change in intention (months) to undergo health screening
Immediately post-intervention
Change in intention (months) to undergo health screening
1 month post-intervention
Change in intention (months) to undergo health screening
3 months post-intervention
Change in knowledge on health screening
Immediately post-intervention
Change in knowledge on health screening
1 month post-intervention
Change in knowledge on health screening
3 months post-intervention

Enrollment

220

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

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

Arm Group Label

Intervention group


Eligibility

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

Gender

Male

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Chirk Jenn Ng, MMed,PhD
Principal Investigator
University of Malaya

Overall Contact

Last Name

Chin Hai Teo, BSc

Phone

+60179192669

Email

teoch@um.edu.my


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Malaya

Investigator Full Name

Professor Ng Chirk Jenn

Investigator Title

Professor Dr


Keywords


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

Control group

Arm Group Type

No Intervention

Description

Participants which are not given the link to the ScreenMen website


Arm Group Label

Intervention group

Arm Group Type

Experimental

Description

Participants will be given the link to the ScreenMen website



Firstreceived Results Date

N/A

Reference

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.

PMID

25638038


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.

PMID

20693148


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.

PMID

23071551


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.

PMID

15631964


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.

PMID

26903153


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.

PMID

27025896


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.

PMID

27614548


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.

PMID

24026317



Acronym

ScreenMen

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Screening

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.


Study First Submitted

June 18, 2018

Study First Submitted Qc

June 28, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 28, 2018

Last Update Submitted Qc

June 28, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on August 29, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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