- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05688748
Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS)
Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS) to Reduce Treatment Delay in Malaysia
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Selangor
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Shah Alam, Selangor, Malaysia, 40000
- Klinik Kesihatan Seksyen 7 Shah Alam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dengue monitoring system
The participants will be given access to download a dengue self-monitoring application and use the application at home to key in their symptoms, three times a day throughout their outpatient follow up for dengue.
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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.
Other Names:
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No Intervention: Usual care
Patients will be managed as per usual outpatient care for dengue in the clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reduction in treatment delay
Time Frame: Up to two weeks
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Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled
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Up to two weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compliance to follow up
Time Frame: Up to two weeks
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Proportion of patients who are compliant of all follow up visits
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Up to two weeks
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Development of warning symptoms
Time Frame: Up to two weeks
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Proportion of patients who develop warning symptoms
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Up to two weeks
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Hospitalization
Time Frame: Up to two weeks
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Proportion of patients with warning symptoms who are admitted to hospital
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Up to two weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wei Leik Ng, University of Malaya
Publications and helpful links
General Publications
- 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.
- 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: 10.2196/16424.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022328-11112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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