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CTRI Number  CTRI/2024/09/074230 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 07/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Understanding the causes of occurrence of Dengue fever and giving Health education to bring awareness among people of Malpe area in Udupi district through WhatsApp . 
Scientific Title of Study   Spatial distribution and risk factor assessment for dengue transmission with a WhatsApp based health literacy intervention for risk reduction in an endemic district of coastal Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Y Manish Raja  
Designation  Post Graduate  
Affiliation  Kasturba Medical College, Manipal  
Address  Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8886300930  
Fax    
Email  manishraja.176@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Eshwari k  
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Manipal  
Address  Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9880460083  
Fax    
Email  eshwari.k@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Y Manish Raja  
Designation  Post Graduate  
Affiliation  Kasturba Medical College, Manipal  
Address  Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8886300930  
Fax    
Email  manishraja.176@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College , Manipal , Karnataka , pincode-576104 
 
Primary Sponsor  
Name  Dr. Y. Manish Raja 
Address  Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal- 576104 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Y Manish Raja  Kasturba Medical College , Manipal Academy of Higher Education , Manipal  Department of Community medicine, 3 rd floor , Kasturba Medical College ,Tiger circle road, Madhav Nagar, Manipal pincode-576104 ,Udupi , Karnataka.
Udupi
KARNATAKA 		 8886300930

manishraja.176@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Risk factor for Dengue Transmission  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  WhatsApp based Health Education   Non Randomised Control trial with pre and post intervention analysis. The study will be conducted among the residents of Malpe. -Residents participated in cross sectional study will be approached for the intervention. -Participants will be explained regarding the study objectives and a written informed consent will be obtained for follow up and reassessment. - After collecting the information as part of cross-sectional study the participants will contacted through WhatsApp individually for delivering the intervention.. - The health literacy intervention will highlight the: Clinical features of dengue and common complications Mode of transmission, vector responsible and its characteristics Various measures to reduce the transmission at household level - The intervention will be provided in a manner that they understand the disease epidemiology and preventive measures. The video intervention will be given at baseline and at end of first and second month with little modification in the intervention. - The intervention will be developed using the video and the images available with district (IEC materials) and inputs from faculty community medicine and district vector borne disease control officer and team. It will be further validated from experts. - The intervention will be shared with participants privately and as well as a WhatsApp group. - The participants will be followed up at the end of three months with the postintervention questionnaire to assess for any change in the knowledge and practices regarding dengue and vector control practices. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Inclusion criteria (Objective 1,2 & 3) :
Households of Malpe with the families residing at least for the last one year

Inclusion criteria (Objective 4) :
Residents ≥ 18 years who possess a smartphone, have access and use WhatsApp.
 
 
ExclusionCriteria 
Details  Exclusion criteria (Objectives 1,2&3):
Households unwilling to participate in the study.

Exclusion criteria (Objective 4)
: Residents who cannot respond to the questions asked by the investigator and who are digitally illiterate . 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
identification and geographical mapping of the high risk areas for dengue transmission in the area   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improved awareness and reduction in the breeding sites among the intervention group   18 months 
 
Target Sample Size   Total Sample Size="782"
Sample Size from India="782" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Objectives:

1. To determine the socio-behavioural and environmental risk factors for dengue

transmission among population in an endemic district of coastal Karnataka.

2. To map the spatial distribution of dengue cases and entomological indices

3. To study the clinical presentation, outcomes and out of pocket expenditure in

patients with dengue fever

4. To evaluate the effectiveness of a WhatsApp-based health literacy intervention for

dengue risk reduction

Methodology

Objectives 1, 2 & 3:

Study Design:

A community-based cross-sectional study will be conducted in Malpe area of Udupi

taluk from May 2024 to March 2025.

Study Setting:

Malpe, located in Udupi district, Karnataka, has a population of 29,854 spread

across six subcentres. Known for its tropical climate and high prevalence of vector-

borne diseases like malaria and dengue.

Study Subjects:

Residents of Malpe, Udupi taluk, who have lived in the area for at least one year.

Inclusion Criteria:

Residents aged ≥18 years willing to provide information about their family and

household characteristics.

Sample Size Estimation:

Based on study by Kamath et al (2012) 5, carried out in Udupi taluk, proportion of

water containers inside houses was found to be 20%, at 95% confidence level with a

15% relative precision and 10% non-response rate, estimated sample size is 782

households.

Probability proportional to size technique will be used to ensure representativeness

of population from all the subcentres under primary health centre of Malpe. In each

subcentre the first household will be selected randomly and will be moved in a

particular direction till the sample size is reached.

Data Collection Methodology:

Ethical approval will be obtained from the Institutional Ethics Committee. Informed

consent will be obtained from all participants. Using a pretested semi-structured

questionnaire, socio-demographic factors, housing and environmentalcharacteristics, knowledge and practices related to dengue disease and vector

characteristics will be collected. Potential breeding sites (larvae & pupae) and vector

control practices will be evaluated using checklist.

Objective 3:

Methodology:

Among households surveyed, any member with a history of lab-confirmed dengue

fever in the past year will be interviewed regarding symptoms, complications,

hospitalization history, and out-of-pocket expenses for disease management.

Objective 4:

Study Design:

A quasi-experimental study with pretest-post-test design will evaluate effectiveness

of a WhatsApp-based health literacy intervention for dengue risk reduction over three

months.

Study Subjects:

Residents of Malpe area who participated in cross-sectional study and meet

inclusion criteria (≥18 years, smartphone users with regular WhatsApp access).

Sample Size:

To expect an improvement of at least 16% (George LS et al,6) in vector prevention

practices postintervention, assuming 95% CI with 10% allowable error, the sample

size estimated for the study is 60, which is inclusive of 10% loss to follow-up. Further

an equal number of participants (household) will be selected across the subcentres.

Data collection methodology and Intervention Details:

A written informed consent will be obtained the intervention will be provided through

WhatsApp individually. Health literacy intervention will highlight Clinical features,

complications, mode of transmission of dengue, vector responsible and its

characteristics and various measures to reduce the transmission.

Video intervention will be given at baseline and at end of first and second month with

little modification in the intervention. The intervention will use images & videos

available with district (IEC materials) and inputs from faculty community medicine and

district vector borne disease control officer and team with validation from experts.

Intervention will be shared with participants privately and as well as a WhatsApp

group. The participants will be followed up at end of three months with postintervention

questionnaire to assess for any change in the knowledge and practices regarding

dengue and vector control practices.

 
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