Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of a Online Education Material to Improve Dengue Knowledge and Health-Seeking Intention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05661877
Recruitment Status : Not yet recruiting
First Posted : December 22, 2022
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Dengue Other: DengueAid mobile application Other: MyHealth website Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : May 6, 2023
Estimated Study Completion Date : May 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: DengueAid intervention group
The participants in this arm would be given the DengueAid mobile app which can be downloaded through Google Play
Other: 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.

Active Comparator: MyHealth website control group
The participants in this arm would be required to use the MyHealth dengue website
Other: MyHealth website
MyHealth is developed by Ministry of Health, Malaysia (http://www.myhealth.gov.my/en/dengue-fever/) to provide information on dengue.




Primary Outcome Measures :
  1. Knowledge on Dengue [ Time Frame: 3 days follow up after enrollment ]
    Mean knowledge score on dengue (0 to 25, higher score means better outcome)


Secondary Outcome Measures :
  1. Health-seeking intention when having dengue fever [ Time Frame: 3 days follow up after enrollment ]
    1. 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."

    2. 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"

    3. 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."

    4. Complementary and alternative medicine (self-care)

      - Percentage of participant agreed to the question on CAM

    5. Medicine and supplements (self-care) - Percentage of participant agreed to the question on medicine and supplements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a social media account
  • Have an android smartphone
  • Understand English or Malay

Exclusion Criteria:

  • Hearing and speech impairment
  • Cognitive impairment
  • Had dengue before
  • Healthcare staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05661877


Contacts
Layout table for location contacts
Contact: Chin Hai Teo +60179192669 teoch@um.edu.my

Locations
Layout table for location information
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
Layout table for investigator information
Principal Investigator: Chin Hai Teo Universiti Malaya
Layout table for additonal information
Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT05661877    
Other Study ID Numbers: 2022104-11592
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Malaya:
dengue
gamification
mobile application
knowledge
health-seeking
Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral