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CTRI Number  CTRI/2025/01/079045 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 29/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding how older adults in coastal Karnataka use technology for their healthcare  
Scientific Title of Study   Digital health literacy of ageing population in 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  S S Neha 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Healthcare and Hospital Management, Room no LH3 Prasanna School of Public Health Tiger Circle Road, Madhav Nagar, Manipal, Udupi Karnataka, India PIN 576104

Udupi
KARNATAKA
576104
India 
Phone  9476093722  
Fax    
Email  neha.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Usha Rani 
Designation  Associate Professor and Head of Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Healthcare and Hospital Management, Room no 68 Prasanna School of Public Health Tiger Circle Road, Madhav Nagar, Manipal, Udupi Karnataka, India PIN 576104

Udupi
KARNATAKA
576104
India 
Phone  9480980246  
Fax    
Email  usha.rani@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Akhila Doddamani 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Community Medicine, Third floor, No division Kasturba Medical College Manipal Academy of Higher Education Tiger Circle Road, Madhav Nagar, Manipal, Udupi Karnataka, India PIN 576104

Udupi
KARNATAKA
576104
India 
Phone  9663703716  
Fax    
Email  akhila.d@manipal.edu  
 
Source of Monetary or Material Support  
Department of Community Medicine, Kasturba Medical College provided access to field practice areas for conducting data collection. Address Department of Community Medicine Kasturba Medical College Manipal Academy of Higher Education Tiger circle road, Madhav Nagar, Manipal, Udupi, Karnataka, India PIN 576104 
Infrastructural support provided by Prasanna School of Public Health Address Department of Healthcare and Hospital Management Prasanna School of Public Health Manipal Academy of Higher Education Tiger Circle Road, Madhav Nagar, Manipal, Udupi, Karnataka, India PIN 576104 
 
Primary Sponsor  
Name  S S Neha 
Address  Department of Healthcare and Hospital Management, Room no LH3 Prasanna School of Public Health Tiger Circle Road, Madhav Nagar, Manipal, Udupi, Karnataka, India PIN 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 Usha Rani  Prasanna School of Public Health  Department of Healthcare and Hospital Management, Room no 68 Prasanna School of Public Health Manipal, Udupi, Karnataka PIN 576104
Udupi
KARNATAKA 
9480980246

usha.rani@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  79.00 Year(s)
Gender  Both 
Details  Individuals residing in the coastal areas of Karnataka, who are willing to participate and give consent to the study.
These participants must be able to understand and respond to the survey in either English or Kannada. 
 
ExclusionCriteria 
Details  Individuals aged below 45 years or above 79 years.
Individuals not willing to participate or not willing to give consent for the study.
Individuals not residing in coastal areas of Karnataka.
Individuals not able to understand and respond in either English or Kannada.
Individuals with severe health conditions or diseases that may prevent them from effectively participating.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The eHEAL tool consisting of 8 questions along with an additional questionnaire consisting of 31 questions will be given to each participant to assess their digital health literacy levels. The outcome will be determined using the data gathered from the questionnaire.   1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying factors influencing digital health literacy in the ageing population.   1 month 
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
Final Enrollment numbers achieved (Total)= "385"
Final Enrollment numbers achieved (India)="385" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) 15/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
The study is a cross-sectional survey aimed at assessing the digital health literacy levels of the ageing population (individuals aged 45 to 79 years) residing in coastal Karnataka. The objectives are to evaluate the current level of digital health literacy among the ageing population in coastal Karnataka and to explore the factors influencing it. Participants will be selected using convenience sampling, with recruitment continuing until the desired sample size is achieved. The inclusion criteria are individuals aged 45 to 79 years, willing to participate, and residing in the coastal area. The exclusion criteria include individuals below 45 years and above 79 years, those not willing to participate or give consent, those not residing in the coastal area, and those with serious health conditions. The questionnaire will be available in both English and Kannada, and only participants able to understand and respond in either of these languages will be selected. Data will be collected using two questionnaires: the eHEALS and a questionnaire prepared by the principal investigator to collect socio-demographic details and digital tool usage patterns of the participants. The data collected will then be analyzed using descriptive and inferential statistics.

 
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