DeSMoS: Effectiveness Evaluation of a Dengue Self-monitoring System

Sponsor
University of Malaya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05688748
Collaborator
Ministry of Health, Malaysia (Other)
30
1
2
8
3.8

Study Details

Study Description

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
  • Other: Dengue self-monitoring system
N/A

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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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 Names:
  • DeSMoS
  • No Intervention: Usual care

    Patients will be managed as per usual outpatient care for dengue in the clinic.

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in treatment delay [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 [Up to two weeks]

      Proportion of patients who are compliant of all follow up visits

    2. Development of warning symptoms [Up to two weeks]

      Proportion of patients who develop warning symptoms

    3. Hospitalization [Up to two weeks]

      Proportion of patients with warning symptoms who are admitted to hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik Kesihatan Seksyen 7 Shah Alam Shah Alam Selangor Malaysia 40000

    Sponsors and Collaborators

    • University of Malaya
    • Ministry of Health, Malaysia

    Investigators

    • Principal Investigator: Wei Leik Ng, University of Malaya

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Malaya
    ClinicalTrials.gov Identifier:
    NCT05688748
    Other Study ID Numbers:
    • 2022328-11112
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Malaya
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2023