Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS)
Primary Purpose
Dengue
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Dengue self-monitoring system
Sponsored by
About this trial
This is an interventional supportive care trial for Dengue focused on measuring dengue, outpatient care, self-monitoring system, treatment delay, warning symptoms
Eligibility 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
Sites / Locations
- Klinik Kesihatan Seksyen 7 Shah AlamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dengue monitoring system
Usual care
Arm Description
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.
Patients will be managed as per usual outpatient care for dengue in the clinic.
Outcomes
Primary Outcome Measures
Reduction in treatment delay
Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled
Secondary Outcome Measures
Compliance to follow up
Proportion of patients who are compliant of all follow up visits
Development of warning symptoms
Proportion of patients who develop warning symptoms
Hospitalization
Proportion of patients with warning symptoms who are admitted to hospital
Full Information
NCT ID
NCT05688748
First Posted
January 5, 2023
Last Updated
March 23, 2023
Sponsor
University of Malaya
Collaborators
Ministry of Health, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05688748
Brief Title
Effectiveness Evaluation of a Dengue Self-monitoring System
Acronym
DeSMoS
Official Title
Effectiveness Evaluation of a Dengue Self-monitoring System (DeSMoS) to Reduce Treatment Delay in Malaysia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
Collaborators
Ministry of Health, Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
dengue, outpatient care, self-monitoring system, treatment delay, warning symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dengue monitoring system
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients will be managed as per usual outpatient care for dengue in the clinic.
Intervention Type
Other
Intervention Name(s)
Dengue self-monitoring system
Other Intervention Name(s)
DeSMoS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in treatment delay
Description
Proportion of patients with warning symptoms who return to see a doctor earlier than scheduled
Time Frame
Up to two weeks
Secondary Outcome Measure Information:
Title
Compliance to follow up
Description
Proportion of patients who are compliant of all follow up visits
Time Frame
Up to two weeks
Title
Development of warning symptoms
Description
Proportion of patients who develop warning symptoms
Time Frame
Up to two weeks
Title
Hospitalization
Description
Proportion of patients with warning symptoms who are admitted to hospital
Time Frame
Up to two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santralega Lingam
Phone
+6017-2254820
Email
santralega@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Leik Ng
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Kesihatan Seksyen 7 Shah Alam
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santralega Lingam
Phone
+6017-2254820
Email
santralega@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei Leik Ng
Phone
+603-79492306
Email
wlng@ummc.edu.my
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24152678
Citation
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.
Results Reference
result
PubMed Identifier
31913128
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness Evaluation of a Dengue Self-monitoring System
We'll reach out to this number within 24 hrs