Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS)
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|ClinicalTrials.gov Identifier: NCT05688748|
Recruitment Status : Recruiting
First Posted : January 18, 2023
Last Update Posted : March 24, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Dengue||Other: Dengue self-monitoring system||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS) to Reduce Treatment Delay in Malaysia|
|Actual Study Start Date :||January 20, 2023|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||September 2023|
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.
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.
Other Name: DeSMoS
No Intervention: Usual care
Patients will be managed as per usual outpatient care for dengue in the clinic.
- Reduction in treatment delay [ Time Frame: Up to two weeks ]Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled
- Compliance to follow up [ Time Frame: Up to two weeks ]Proportion of patients who are compliant of all follow up visits
- Development of warning symptoms [ Time Frame: Up to two weeks ]Proportion of patients who develop warning symptoms
- Hospitalization [ Time Frame: Up to two weeks ]Proportion of patients with warning symptoms who are admitted to hospital
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18 years old and above
- Newly diagnosed with dengue fever
- Have a smartphone
- Receiving outpatient follow up for dengue
- Hearing and speech impairment
- Cognitive impairment
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): NCT05688748
|Contact: Santralega Lingamfirstname.lastname@example.org|
|Klinik Kesihatan Seksyen 7 Shah Alam||Recruiting|
|Shah Alam, Selangor, Malaysia, 40000|
|Contact: Santralega Lingam +6017-2254820 email@example.com|
|Contact: Wei Leik Ng +603-79492306 firstname.lastname@example.org|
|Principal Investigator:||Wei Leik Ng||University of Malaya|
|Responsible Party:||University of Malaya|
|Other Study ID Numbers:||
|First Posted:||January 18, 2023 Key Record Dates|
|Last Update Posted:||March 24, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Vector Borne Diseases
RNA Virus Infections
Hemorrhagic Fevers, Viral