Effectiveness Evaluation of a Dengue Self-monitoring System

NCT ID: NCT05688748

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dengue

Keywords

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dengue outpatient care self-monitoring system treatment delay warning symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dengue self-monitoring system

Intervention Type OTHER

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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DeSMoS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Leik Ng

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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Klinik Kesihatan Seksyen 7 Shah Alam

Shah Alam, Selangor, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type RESULT
PMID: 24152678 (View on PubMed)

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.

Reference Type RESULT
PMID: 31913128 (View on PubMed)

Other Identifiers

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2022328-11112

Identifier Type: -

Identifier Source: org_study_id