Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer

November 28, 2024 updated by: Kehinde Kazeem Kanmodi, University of Rwanda

A Comparative Analysis of the Effectiveness, Usability, Uptake, and Acceptability of an Educational Website and a Mobile Health Application Prototype in Improving Knowledge on Oral Cancer

Introduction: Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx. Despite the intense and diverse public health interventions on oral cancer prevention, the global prevalence rates of oral cancer and its major risk factors are still very high. Hence, oral cancer is an issue of serious global health importance.

Aim: To test and compare the effectiveness, usability, uptake, and acceptability of an educational website and a mobile health application prototype on oral cancer in improving oral cancer knowledge among university students.

Methods: This study will adopt a randomised control trial design, and it will be conducted among 75 first-year bachelor's degree students from five universities across two continents: University of Rwanda (Rwanda, Africa), Usmanu Danfodiyo University (Nigeria, Africa), University of Peradeniya (Sri Lanka, Asia), University of Ibadan (Nigeria), and Saveetha University (India, Aisa). The study participants will be in three groups (Group 1, Group 2, and Group 3). The participants in Group 1 will be the control group (n = 25 participants; 5 participants from each university); that is the group that will not receive an educational intervention. However, those in Group 2 (n = 25 participants; 5 participants from each university) will receive a web-based educational intervention on oral cancer while those in Group 3 (n = 25 participants; 5 participants from each university) will receive an app-based educational intervention on oral cancer. Pretest survey and posttest survey will be done for all participants. The data collected will be statistically analysed using the Statistical Package for Social Sciences (SPSS) version 28 software. Descriptive statistics will be done for all variables while inferential statistics (analysis of variance) will be done to test for associations between variables of interest.

Conclusion: The findings of this study will determine the effectiveness, usability, uptake, and acceptability of the tested digital intervention tools.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Tamil Nadu, India
        • Saveetha University
        • Contact:
        • Contact:
          • Karthikeyan Ramalingam, BDS, MDS
  • Nigeria
      • Sokoto, Nigeria
        • Usmanu Danfodiyo University
        • Contact:
        • Contact:
          • Jimoh Amzat, BSc, MA, MSc, PhD
        • Contact:
          • Bello Almu, BSc, MPP, MSc
    • Oyo
      • Ibadan, Oyo, Nigeria
        • University of Ibadan
        • Contact:
        • Contact:
          • Akinyele Adisa, BDS
          • Phone Number: +2348037252207
        • Contact:
          • Afeez Salami, BDS
        • Contact:
          • Akinyele Adisa, BDS
        • Contact:
          • Timothy Aladelusi, BDS, MSc
  • Rwanda
      • Kigali, Rwanda
        • University of Rwanda
        • Contact:
        • Contact:
          • Kehinde Kanmodi, BDS, MPH, PhD
        • Contact:
          • Peace Uwambaye, BSc, MPH, PhD
  • Sri Lanka
      • Peradeniya, Sri Lanka
        • University of Peradeniya
        • Contact:
        • Contact:
          • Ruwan Jayasinghe, BDS, MSc
        • Contact:
          • Yovanthi Jayasinghe, BSc, PGD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being a first-year bachelor degree student of either University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
  • being within the age range of 18 to 39 years
  • having a personal smartphone
  • willingness to participate in the study

Exclusion Criteria:

  • being a member of staff or a visitor or a non-first year bachelor degree student of University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
  • being a student of a tertiary institution not selected for the study
  • being below the age of 18 years or above the age of 39 years.
  • not having a personal smartphone
  • not willing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
This is the control group (arm). No educational intervention on oral cancer will be administered to this group.
Experimental: Web-based Intervention Group
A web-based educational intervention on oral cancer will be administered to this group.
Behavioral: A web-based educational intervention on oral cancer
This intervention will involve administering education, via a website, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.
Experimental: mHealth-based Intervention Group
An app-based educational intervention on oral cancer will be administered to this group.
Behavioral: A mobile health app-based educational intervention on oral cancer
This intervention will involve administering education, via a mhealth application prototype, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of change in baseline knowledge on oral cancer four weeks post-intervention using a questionnaire
Time Frame: From enrollment to the end of educational intervention at 4 weeks

This primary outcome measure will be a change in knowledge on oral cancer at four weeks after the delivery of the intervention, and this will be done using a questionnaire. All participants in both the control and intervention groups will be evaluated at baseline and at endline.

This outcome will be measured using a questionnaire. This questionnaire was developed by the investigators. The questionnaire will obtain assess the participants' knowledge of oral cancer through the use of 10 multiple choice questions
From enrollment to the end of educational intervention at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the usability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
Time Frame: At the end of educational intervention at 4 weeks

This secondary outcome measure will be on the usability of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's usability) while a score of 5 representing the extreme positive outcome (highest rating on the tool's usability).
At the end of educational intervention at 4 weeks
Measurement of the uptake of the intervention tools using an adapted version of the user Mobile Application Rating Scale
Time Frame: At the end of educational intervention at 4 weeks

This secondary outcome measure will be on the uptake of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's uptake) while a score of 5 representing the extreme positive outcome (highest rating on the tool's uptake)
At the end of educational intervention at 4 weeks
Measurement of the acceptability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
Time Frame: At the end of educational intervention at 4 weeks

This secondary outcome measure will be on the acceptability of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's acceptability) while a score of 5 representing the extreme positive outcome (highest rating on the tool's acceptability).
At the end of educational intervention at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rwanda

Collaborators

University of Ibadan
University of Peradeniya
Saveetha University
Usmanu Danfodiyo University

Investigators

  • Principal Investigator: Kehinde Kanmodi, BDS, MPH, University of Rwanda
  • Study Director: Peace Uwambaye, BSC, MPH, PhD, University of Rwanda
  • Study Director: Afeez Salami, BDS, University of Ibadan
  • Study Director: Bello Almu, BSC, MSc, MPP, Usmanu Danfodiyo University
  • Study Director: Karthikeyan Ramalingam, BDS, MDS, Saveetha University
  • Study Director: Yovanthi Jayasinghe, BSc, PGD, University of Peradeniya
  • Study Director: Timothy Aladelusi, BDS, MSc, University of Ibadan
  • Study Director: Akinyele Adisa, BDS, University of Ibadan
  • Study Director: Jimoh Amzat, BSC, MA, MSc, PhD, Usmanu Danfodiyo University
  • Principal Investigator: Ruwan Jayasinghe, BDS, MSc, University of Peradeniya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2025

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No 595/CMHS IRB/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The names, and any other personal information that could potentially identify the participants will not appear in any reports or publications. The participants will be assigned a unique study identifying number (or pseudonym) which will be recorded only on a link document. This link document will be stored separately on the U-drive from both the person identifiable consent forms and the pseudo-anonymised data. Any participant that wishes to withdraw would email the researcher without giving a reason. As soon as the last date allowed for withdrawal has passed the coding (link) document will be securely destroyed and the data rendered non-person identifiable. Withdrawal is not possible after this point.

The consent form will be stored for up to 10 years on the U-drive of the principal investigators, separate to other study data, as it is an important document. This is in case other scientists wish to raise questions about the results that need checking again.

IPD Sharing Time Frame

Start date: 05 June 2025 End date: 05 May 2035

IPD Sharing Access Criteria

Only the anonymised IPD documents will be shared and such can be shared upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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