NCT03583840

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

June 18, 2018

Last Update Submit

July 21, 2019

Conditions

Keywords

men's healthinternettelemedicinemass screeninghealth behavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Participants who will not be directed to the ScreenMen website

Intervention group

EXPERIMENTAL

Participants who will be directed to the ScreenMen website

Behavioral: ScreenMen website

Interventions

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • year old and above
  • Own a smart phone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Malaysia

Location

Related 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.

    PMID: 25638038BACKGROUND
  • 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: 20693148BACKGROUND
  • 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: 23071551BACKGROUND
  • 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.

    PMID: 15631964BACKGROUND
  • 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: 26903153BACKGROUND
  • 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.

    PMID: 27025896BACKGROUND
  • 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: 27614548BACKGROUND
  • 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: 24026317BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chirk Jenn Ng, MMed,PhD

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 11, 2018

Study Start

March 27, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations