DengueNCT05661877
Effectiveness of a Online Education Material to Improve Dengue Knowledge and Health-Seeking Intention
A study testing DengueAid mobile application and MyHealth website in people with Dengue, run by University of Malaya at 1 site in Malaysia.
Trial summary
Dengue is an endemic infectious disease in Malaysia. Delays in seeking treatment and improper self-care contribute to dengue complications and mortality. A mobile app (Dengue Aid) was developed to educate and empower patients to perform evidence-based self-care when having dengue fever. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- DengueAid mobile application and MyHealth website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2023to 6 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a social media account
- Have an android smartphone
- Understand English or Malay
Who cannot join
- Hearing and speech impairment
- Cognitive impairment
- Had dengue before
- Healthcare staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Online Education Material to Improve Dengue Knowledge and Health-Seeking Intention Among the General Population: An Online Randomized Controlled Trial Via Facebook
Dengue is an endemic infectious disease in Malaysia. Delays in seeking treatment and improper self-care contribute to dengue complications and mortality. A mobile app (Dengue Aid) was developed to educate and empower patients to perform evidence-based self-care when having dengue fever. DengueAid is hypothesised to improve people's knowledge and health-seeking intention on dengue. This will be evaluated via an online randomised controlled trial. Adults aged 18 and above who have Facebook, an android smartphone and understand either English or Malay language will be recruited through Facebook advertisements. Eligible participants would be randomized to either using the DengueAid app (intervention) or MyHEALTH website (control). An online randomizer tool will be used to randomize participants into the intervention or control group. Participants in both arms would complete a post-intervention online questionnaire (knowledge and health-seeking intention) three days after recruitment.
Read the detailed description
The public have shown increasing interest in having health information disseminated to them through smartphones. The current usage of health-related smartphone apps was over 500 million people. In addition, studies have shown that the use of gamification produced positive effect on users' engagement in learning about health and led to positive change in the behaviour for their health and wellness. Several previous studies have shown the effectiveness of mobile applications in promoting health related information. A pilot randomized control trial among coronary heart disease (CHD) patients found that participants in the intervention group (Care4Heart app) showed better overall CHD knowledge levels than participants in the control group (website of Singapore Heart Foundation).
For dengue fever, an integrated mobile health app (Mozzify) was developed and may improve knowledge on dengue fever and promote dissemination and sharing of information on dengue fever among the public and health practitioners. During the development, suggestions to improve the engagement of the app included the addition of games to encourage the public to use it more frequently. Adding to this, the concept of gamification is increasingly being used in health education applications since 2010. Studies have shown that the use of gamification produced positive effect on users' engagement in learning about health and led to positive change in the behaviour for their health and wellness.
As both mobile applications and gamification show increasing importance in the field of mHealth, the DengueAid app was developed to improving monitoring of the disease and knowledge on dengue fever. Previous studies on the effectiveness of a gamified mobile app to improve dengue knowledge was limited to none. In this era of digitalization, an effective gamified mobile intervention for dengue fever which consistently affect the Malaysian population should be developed. Hence, for this study, the effectiveness of DengueAid in improving dengue knowledge among the public will be evaluated through a randomized control trial (RCT).
The sample size was decided on based on previous literature involving the use of a gamified mobile application to improve knowledge on oral health. For a full RCT, using mean and standard deviation values from a previous study (Control Group 13.1 ± 1.6, Intervention Group 14.3 ± 2.0) with 90% power and alpha of 0.05, the estimated sample size is 48 in each arm. Considering a 20% dropout rate the final number of participants recruited would be 116 (58 in each arm).
The study will be advertised on a social media platform (Facebook). Lay public who are interested to join the study will click on a link in the advertisement. The participants will then read the study information sheet and undergo an eligibility check to determine if they are suitable to join the study. Participants who have hearing and speech impairment, cognitive impairment, had dengue before and healthcare staff would be excluded from the study. Participants who are eligible would then have to complete a consent form and provide sociodemographic details. They will then be randomized using an online randomizer to either intervention or control groups. They will be given three days to complete using the intervention/control materials.
Participants in both study arms, would be given three days to complete the online education material (intervention: DengueAid app; control: MyHEALTH website). The research assistant will send an online questionnaire three days after the enrollment day. The questionnaire consists of questions on knowledge on dengue fever based on the modules and content of the DengueAid app as well as questions on health-seeking intention. The questionnaire will be developed using REDCap. Each participant will be compensated with RM30 once they completed the post-intervention online questionnaire.
- Conditions
- Dengue
- Being tested
- DengueAid mobile application, MyHealth website
- Keywords
- dengue, gamification, mobile application, knowledge, health-seeking
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DengueAid mobile applicationOther
•Education materials regarding dengue fever and self-care. The education section (My Dengue Knowledge) consists of seven modules (dengue essentials, risk, symptoms, aedes mosquito, self-care, prevention and interesting facts) with gamification properties. Each module contains a series of multiple-choice questions. After answering each question, the user would be instantly notified if they had answered the question correctly and be provided with some facts related to the question. A progress meter would allow users to keep track of each module answered. A medal would be awarded to users who have completed 100% of each module. The self-care section consists of basic information about dengue fever and points to look out for self-care. It contains information on dengue fever phases, signs of dengue, importance of keeping hydrated, complementary therapy, medicine to avoid and prevention practices.
MyHealth websiteOther
MyHealth is developed by Ministry of Health, Malaysia (http://www.myhealth.gov.my/en/dengue-fever/) to provide information on dengue.
| Study group | Role | What they receive |
|---|---|---|
| DengueAid intervention group | Experimental | The participants in this arm would be given the DengueAid mobile app which can be downloaded through Google Play Receives: Other: DengueAid mobile application |
| MyHealth website control group | Active comparator | The participants in this arm would be required to use the MyHealth dengue website Receives: Other: MyHealth website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge on Dengue
Mean knowledge score on dengue (0 to 25, higher score means better outcome)
Measured: 3 days follow up after enrollment
Secondary outcomes (1)
Health-seeking intention when having dengue fever
- First doctor's visit (medical attention)
- Percentage of participant agreed to the question "I will see a doctor when I have fever and if there are dengue cases in my neighbourhood."
- Follow-up doctors visit (medical attention)
- Percentage of participant agreed to the question "I will follow doctor's advice and attend all follow ups when diagnosed with dengue"
- Emergency doctors visit due to warning signs (medical attention)
- Percentage of participant agreed to the question "I will seek medical attention immediately if I have either one of the warning signs of dengue such as abdominal pain, blood in stool/vomit, bleeding gums/nose, persistent vomiting/diarrhoea, drowsiness or irritability."
- Complementary and alternative medicine (self-care)
- Percentage of participant agreed to the question on CAM
- Medicine and supplements (self-care) - Percentage of participant agreed to the question on medicine and supplements
Measured: 3 days follow up after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion6 May 2023 (estimated)
- Study completion6 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin Hai Teo, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661877
- Sponsor's protocol ID
- 2022104-11592
- Status last verified
- Dec 2022
- First submitted
- 14 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Education Material to Improve Dengue Knowledge and Health-Seeking Intention Among the General Population: An Online Randomized Controlled Trial Via Facebook
- ClinicalTrials.gov ID
- NCT05661877
- Acronym / sponsor ID
- 2022104-11592
- Conditions
- Dengue
- Keywords
- dengue, gamification, mobile application, knowledge, health-seeking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 6 May 2023 (estimated)
- Study completion
- 6 May 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dengue is an endemic infectious disease in Malaysia. Delays in seeking treatment and improper self-care contribute to dengue complications and mortality. A mobile app (Dengue Aid) was developed to educate and empower patients to perform evidence-based self-care when having dengue fever. DengueAid is hypothesised to improve people's knowledge and health-seeking intention on dengue. This will be evaluated via an online randomised controlled trial. Adults aged 18 and above who have Facebook, an android smartphone and understand either English or Malay language will be recruited through Facebook advertisements. Eligible participants would be randomized to either using the DengueAid app (intervention) or MyHEALTH website (control). An online randomizer tool will be used to randomize participants into the intervention or control group. Participants in both arms would complete a post-intervention online questionnaire (knowledge and health-seeking intention) three days after recruitment.
Detailed description
The public have shown increasing interest in having health information disseminated to them through smartphones. The current usage of health-related smartphone apps was over 500 million people. In addition, studies have shown that the use of gamification produced positive effect on users' engagement in learning about health and led to positive change in the behaviour for their health and wellness. Several previous studies have shown the effectiveness of mobile applications in promoting health related information. A pilot randomized control trial among coronary heart disease (CHD) patients found that participants in the intervention group (Care4Heart app) showed better overall CHD knowledge levels than participants in the control group (website of Singapore Heart Foundation).
For dengue fever, an integrated mobile health app (Mozzify) was developed and may improve knowledge on dengue fever and promote dissemination and sharing of information on dengue fever among the public and health practitioners. During the development, suggestions to improve the engagement of the app included the addition of games to encourage the public to use it more frequently. Adding to this, the concept of gamification is increasingly being used in health education applications since 2010. Studies have shown that the use of gamification produced positive effect on users' engagement in learning about health and led to positive change in the behaviour for their health and wellness.
As both mobile applications and gamification show increasing importance in the field of mHealth, the DengueAid app was developed to improving monitoring of the disease and knowledge on dengue fever. Previous studies on the effectiveness of a gamified mobile app to improve dengue knowledge was limited to none. In this era of digitalization, an effective gamified mobile intervention for dengue fever which consistently affect the Malaysian population should be developed. Hence, for this study, the effectiveness of DengueAid in improving dengue knowledge among the public will be evaluated through a randomized control trial (RCT).
The sample size was decided on based on previous literature involving the use of a gamified mobile application to improve knowledge on oral health. For a full RCT, using mean and standard deviation values from a previous study (Control Group 13.1 ± 1.6, Intervention Group 14.3 ± 2.0) with 90% power and alpha of 0.05, the estimated sample size is 48 in each arm. Considering a 20% dropout rate the final number of participants recruited would be 116 (58 in each arm).
The study will be advertised on a social media platform (Facebook). Lay public who are interested to join the study will click on a link in the advertisement. The participants will then read the study information sheet and undergo an eligibility check to determine if they are suitable to join the study. Participants who have hearing and speech impairment, cognitive impairment, had dengue before and healthcare staff would be excluded from the study. Participants who are eligible would then have to complete a consent form and provide sociodemographic details. They will then be randomized using an online randomizer to either intervention or control groups. They will be given three days to complete using the intervention/control materials.
Participants in both study arms, would be given three days to complete the online education material (intervention: DengueAid app; control: MyHEALTH website). The research assistant will send an online questionnaire three days after the enrollment day. The questionnaire consists of questions on knowledge on dengue fever based on the modules and content of the DengueAid app as well as questions on health-seeking intention. The questionnaire will be developed using REDCap. Each participant will be compensated with RM30 once they completed the post-intervention online questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DengueAid intervention group | Experimental | Other: DengueAid mobile applicationThe participants in this arm would be given the DengueAid mobile app which can be downloaded through Google Play |
| MyHealth website control group | Active comparator | Other: MyHealth websiteThe participants in this arm would be required to use the MyHealth dengue website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a social media account
- Have an android smartphone
- Understand English or Malay
Key exclusion criteria (4 listed)
- Hearing and speech impairment
- Cognitive impairment
- Had dengue before
- Healthcare staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DengueAid mobile application•Education materials regarding dengue fever and self-care. The education section (My Dengue Knowledge) consists of seven modules (dengue essentials, risk, symptoms, aedes mosquito, self-care, prevention and interesting facts) with gamification properties. Each module contains a series of multiple-choice questions. After answering each question, the user would be instantly notified if they had answered the question correctly and be provided with some facts related to the question. A progress meter would allow users to keep track of each module answered. A medal would be awarded to users who have completed 100% of each module. The self-care section consists of basic information about dengue fever and points to look out for self-care. It contains information on dengue fever phases, signs of dengue, importance of keeping hydrated, complementary therapy, medicine to avoid and prevention practices. | Other | DengueAid intervention group |
| MyHealth websiteMyHealth is developed by Ministry of Health, Malaysia (http://www.myhealth.gov.my/en/dengue-fever/) to provide information on dengue. | Other | MyHealth website control group |
Primary outcome
Knowledge on Dengue
Time frame: 3 days follow up after enrollment
Mean knowledge score on dengue (0 to 25, higher score means better outcome)
1 secondary outcome
Health-seeking intention when having dengue fever
Time frame: 3 days follow up after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
Related trials for Dengue
Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Hai Teo principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DengueAid mobile application and MyHealth website in people with Dengue, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin Hai Teo (+60179192669, teoch@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge on Dengue (time frame: 3 days follow up after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.