Clinical trial NCT06711848: Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Cancer
Health Education, Community
Digital Intervention
MHealth Application
MHealth Intervention
Keywords: mobile health
application
website
impact
knowledge
oral cancer
public health
intervention
Lead sponsor: University of Rwanda
Sponsor class: OTHER
Collaborators: name: University of Peradeniya
name: University of Ibadan
name: Usmanu Danfodiyo University
name: Saveetha University
First posted: 2024-12-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of change in baseline knowledge on oral cancer four weeks post-intervention using a questionnaire
timeFrame: From enrollment to the end of educational intervention at 4 weeks
Secondary outcomes:
measure: Measurement of the usability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
timeFrame: At the end of educational intervention at 4 weeks
measure: Measurement of the uptake of the intervention tools using an adapted version of the user Mobile Application Rating Scale
timeFrame: At the end of educational intervention at 4 weeks
measure: Measurement of the acceptability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
timeFrame: At the end of educational intervention at 4 weeks
Other outcomes:
Locations:
city: Tamil Nadu
country: India
facility: Saveetha University
city: Ibadan
country: Nigeria
facility: University of Ibadan
state: Oyo
city: Sokoto
country: Nigeria
facility: Usmanu Danfodiyo University
city: Kigali
country: Rwanda
facility: University of Rwanda
city: Peradeniya
country: Sri Lanka
facility: University of Peradeniya
Study officials:
affiliation: University of Rwanda
name: Kehinde Kanmodi, BDS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rwanda
name: Peace Uwambaye, BSC, MPH, PhD
role: STUDY_DIRECTOR
affiliation: University of Ibadan
name: Afeez Salami, BDS
role: STUDY_DIRECTOR
affiliation: Usmanu Danfodiyo University
name: Bello Almu, BSC, MSc, MPP
role: STUDY_DIRECTOR
affiliation: Saveetha University
name: Karthikeyan Ramalingam, BDS, MDS
role: STUDY_DIRECTOR
affiliation: University of Peradeniya
name: Yovanthi Jayasinghe, BSc, PGD
role: STUDY_DIRECTOR
affiliation: University of Ibadan
name: Timothy Aladelusi, BDS, MSc
role: STUDY_DIRECTOR
affiliation: University of Ibadan
name: Akinyele Adisa, BDS
role: STUDY_DIRECTOR
affiliation: Usmanu Danfodiyo University
name: Jimoh Amzat, BSC, MA, MSc, PhD
role: STUDY_DIRECTOR
affiliation: University of Peradeniya
name: Ruwan Jayasinghe, BDS, MSc
role: PRINCIPAL_INVESTIGATOR
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