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CTRI Number  CTRI/2023/06/053441 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 01/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of travel health education among international travellers  
Scientific Title of Study   Effectiveness of mobile application-based education on pre-travel health seeking attitude and knowledge among potential international travellers in East India: Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angel Ivy Linda 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  bioinformatics room, Academic block, AIIMS Bhubaneswar, Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  8757257441  
Fax    
Email  angelivylinda5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swayam Pragyan Parida 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  academic block, AIIMS Bhubaneswar, Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  9438884019  
Fax    
Email  cmfm_swayam@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Swayam Pragyan Parida 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  academic block, AIIMS Bhubaneswar, Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  9438884019  
Fax    
Email  cmfm_swayam@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar, Sijua Patrapada-751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar, Sijua, Patrapada- 751019 
Type of Sponsor  Research institution and hospital 
 
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 
Angel Ivy Linda  All India Institute of Medical Sciences, Bhubaneswar  Room no 52, Yellow Fever Vaccination Centre, AIIMS Bhubaneswar, Sijua Patrapada-751019
Khordha
ORISSA 		 8757257441

angelivylinda5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy individuals above 18 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  non interventional group  the participants in the control group will not be given the mobile application containing travel health  
Intervention  travel health education in the form of mobile based application  Participants in the interventional group will be given travel health education on two occasion. On first point of contact in the clinic where the participant will be counselled on travel health and will be provided with a mobile application developed by the investigator and will be educated on how to use it. Second, after a week, follow-up will be done to ensure the use of mobile application by the participants and a brief education will be given via online mode. Frequency of intervention is twice. On day one and then a week later. Duration is one month, after being enrolled. And then follow-up and end-line assessment will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  those who will give consent to participate 
 
ExclusionCriteria 
Details  Individuals who fail to comprehend 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pre-travel health seeking attitude and knowledge among participants  six months 
 
Secondary Outcome  
Outcome  TimePoints 
Pre-travel health seeking attitude and knowledge among international travellers in east India  six months 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   01/07/2023 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomized parallel group, two-armed controlled trial to assess the effectiveness of mobile-based education on pre-travel heath seeking attitude and knowledge among potential international travellers in east India. The study will be conducted in Yellow fever vaccination clinic of AIIMS Bhubaneswar, Khordha district of Odisha, India. The participants who will fulfill the inclusion criteria will be randomized  and allocated into intervention and non-intervention groups. The intervention will be given in the form of mobile based application(travel health education) and baseline and endline assessment will be done using a semi-structured  interview based questionnaire. The intervention will be done for a period of one month. And pre-travel health seeking attitude  and knowledge will be assessed. The study will help scientific committee  to understand travel health knowledge and attitude among international travellers and to formulate a travel health module. 
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