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Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS)

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: NCT05688748
Recruitment Status : Not yet recruiting
First Posted : January 18, 2023
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
University of Malaya

Brief 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.


Condition or disease Intervention/treatment Phase
Dengue Other: Dengue self-monitoring system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Compliance to follow up [ Time Frame: Up to two weeks ]
    Proportion of patients who are compliant of all follow up visits

  2. Development of warning symptoms [ Time Frame: Up to two weeks ]
    Proportion of patients who develop warning symptoms

  3. Hospitalization [ Time Frame: Up to two weeks ]
    Proportion of patients with warning symptoms who are admitted to hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT05688748


Contacts
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Contact: Santralega Lingam +6017-2254820 santralega@gmail.com

Locations
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Malaysia
Klinik Kesihatan Seksyen 7 Shah Alam
Shah Alam, Selangor, Malaysia, 40000
Contact: Santralega Lingam    +6017-2254820    santralega@gmail.com   
Contact: Wei Leik Ng    +603-79492306    wlng@ummc.edu.my   
Sponsors and Collaborators
University of Malaya
Ministry of Health, Malaysia
Investigators
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Principal Investigator: Wei Leik Ng University of Malaya
Publications of Results:
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT05688748    
Other Study ID Numbers: 2022328-11112
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
outpatient care
self-monitoring system
treatment delay
warning symptoms
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral