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

21. Juli 2019 aktualisiert von: Professor Ng Chirk Jenn, University of Malaya

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

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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

220

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control group
Participants who will not be directed to the ScreenMen website
Experimental: Intervention group
Participants who will be directed to the ScreenMen website
Verhalten: ScreenMen website
An educational website that aims to improve evidence-based health screening uptake in men

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants who have undergone health screening
Zeitfenster: 1 month post-intervention

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
Zeitfenster: 3 months post-intervention

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in intention (months) to undergo health screening
Zeitfenster: Immediately post-intervention

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
Change in intention (months) to undergo health screening
Zeitfenster: 1 month post-intervention

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
Change in intention (months) to undergo health screening
Zeitfenster: 3 months post-intervention

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
Change in knowledge on health screening
Zeitfenster: Immediately post-intervention

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
Change in knowledge on health screening
Zeitfenster: 1 month post-intervention

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
Change in knowledge on health screening
Zeitfenster: 3 months post-intervention

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Malaya

Mitarbeiter

University of Sheffield
The University of New South Wales
Leeds Beckett University

Ermittler

  • Hauptermittler: Chirk Jenn Ng, MMed,PhD, University of Malaya

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. März 2019

Primärer Abschluss (Voraussichtlich)

1. September 2019

Studienabschluss (Voraussichtlich)

1. Oktober 2019

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juni 2018

Zuerst gepostet (Tatsächlich)

11. Juli 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juli 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2019

Zuletzt verifiziert

1. Juli 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • RP041A-15HTM

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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