Effectiveness Evaluation of a Dengue Self-monitoring System

Dengue Clinical Trial

— DeSMoS  

Official title:

Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS) to Reduce Treatment Delay in Malaysia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688748
• Other study ID #: 2022328-11112
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of a dengue self-monitoring system with standard care in reducing treatment delay among dengue patients receiving outpatient care. The main question it aims to answer are:

• Is a dengue self-monitoring system effective in reducing treatment delay in dengue patients? Participants will use the dengue monitoring system in addition to the standard care they are receiving for outpatient follow up for dengue.

Researchers will compare them with dengue patients receiving the usual standard care to see if the dengue monitoring system reduces delay in treatment seeking in patients.

Description:

Dengue Self-Monitoring System (DeSMoS) was developed to guide patients about warning signs and advise them to visit a doctor appropriately before their scheduled follow up on the next day, apart from motivating them to comply to the daily follow up visits at the clinic. DeSMoS is hypothesised to effectively reduce delay in treatment seeking in dengue patients.

The main aim of this system is to get dengue patients to key-in their symptoms regularly via the app when they are at home. Reminders will appear on the phone to remind them to key in the symptoms thrice daily.

The system is designed as a supportive tool for outpatient dengue management. It is not meant to replace to usual standard care for dengue care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years old and above

• Newly diagnosed with dengue fever

• Have a smartphone

• Receiving outpatient follow up for dengue

Exclusion Criteria:

• Hearing and speech impairment

• Cognitive impairment

Related Conditions & MeSH terms

• Dengue

Intervention

Other:
• Dengue self-monitoring system
The system has a symptom monitoring algorithm whereby patient would be asked to report their symptoms thrice daily (9am, 2pm and 8pm). The algorithm is developed by the researchers which consist of primary care doctors, emergency physician and infectious disease specialists. If the patient reports warning symptoms (persistent vomiting, persistent diarrhoea, abdominal pain, bleeding, difficulty breathing, feel like fainting, difficulty carrying out usual activities, drowsiness, reduced urine output and reduced urine output), the system will advise patients to seek earlier medical care instead of waiting for the scheduled appointment the next day/other days.

Locations

Country	Name	City	State
Malaysia	Klinik Kesihatan Seksyen 7 Shah Alam	Shah Alam	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

Herbuela VRDM, Karita T, Francisco ME, Watanabe K. An Integrated mHealth App for Dengue Reporting and Mapping, Health Communication, and Behavior Modification: Development and Assessment of Mozzify. JMIR Form Res. 2020 Jan 8;4(1):e16424. doi: 10.2196/1642 — View Citation

Leo YS, Gan VC, Ng EL, Hao Y, Ng LC, Pok KY, Dimatatac F, Go CJ, Lye DC. Utility of warning signs in guiding admission and predicting severe disease in adult dengue. BMC Infect Dis. 2013 Oct 24;13:498. doi: 10.1186/1471-2334-13-498. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in treatment delay	Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled	Up to two weeks
Secondary	Compliance to follow up	Proportion of patients who are compliant of all follow up visits	Up to two weeks
Secondary	Development of warning symptoms	Proportion of patients who develop warning symptoms	Up to two weeks
Secondary	Hospitalization	Proportion of patients with warning symptoms who are admitted to hospital	Up to two weeks