NCT05688748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

January 5, 2023

Last Update Submit

December 7, 2023

Conditions

Dengue

Keywords

dengueoutpatient careself-monitoring systemtreatment delaywarning symptoms

Outcome Measures

Primary Outcomes (1)

  • Reduction in treatment delay

    Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled

    Up to two weeks

Secondary Outcomes (3)

  • Compliance to follow up

    Up to two weeks

  • Development of warning symptoms

    Up to two weeks

  • Hospitalization

    Up to two weeks

Study Arms (2)

Dengue monitoring system

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

Dengue self-monitoring systemOTHER

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.

Also known as: DeSMoS
Dengue monitoring system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years old and above
  • Newly diagnosed with dengue fever
  • Have a smartphone
  • Receiving outpatient follow up for dengue

You may not qualify if:

  • Hearing and speech impairment
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Kesihatan Seksyen 7 Shah Alam

Shah Alam, Selangor, 40000, Malaysia

Location

Related Publications (2)

  • 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.

    PMID: 24152678RESULT

  • 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.

    PMID: 31913128RESULT

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Wei Leik Ng

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 18, 2023

Study Start

January 20, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)