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CTRI Number  CTRI/2025/01/079230 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Studying the Challenges and Ways to Help Older People in Udupi District Understand and Use Digital Health Services 
Scientific Title of Study   An exploratory study of Facilitators and Barriers Among Ageing and Elderly Population of Udupi District on Digital Health literacy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nourin Biju 
Designation  Student  
Affiliation  Manipal academy of higher education  
Address  Department of Healthcare and Hospital Management no division Room no LH3 Tiger Circle Road, Madhav Nagar,Manipal,Karnataka,India Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8547923528  
Fax    
Email  nourin.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Usha Rani  
Designation  Associate professor  
Affiliation  Manipal academy of higher education  
Address  Department of Healthcare and Hospital Management no division Room no 56 Tiger Circle Road, Madhav Nagar,Manipal,Karnataka,India Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8310214742  
Fax    
Email  usha.rani@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Usha Rani  
Designation  Associate professor  
Affiliation  Manipal academy of higher education  
Address  Department of Healthcare and Hospital Management no division Room no 56 Tiger Circle Road, Madhav Nagar,Manipal,Karnataka,India Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8310214742  
Fax    
Email  usha.rani@manipal.edu  
 
Source of Monetary or Material Support  
An exploratory study of Facilitators and Barriers Among Ageing and Elderly Population of Udupi District on Digital Health literacy,is conducted with the infrastructural support provided by: Prasanna school of public health, Manipal academy of higher education Tiger Circle Road , Madhav Nagar Manipal Udupi Karnataka India pin: 576104 
 
Primary Sponsor  
Name  Nourin  
Address  Department of Healthcare and Hospital Management,No division Room no LH3 Tiger Circle Road,Madav Nagar, Manipal,Karnataka, India 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 no division Room no 68 Tiger Cicle Road, Madhav Nagar,Manipal,Karnataka,India pin:576104
Udupi
KARNATAKA 
8310214742

usha.rani@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba Medical college and Kasturba Hospital instituional ethics committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  digital health literacy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Participants who are 45 years and above willing to participate in the study.
2.Ageing and elderly population
3. Mentally and physically stable participants
4. Participants who understands english or kannada
 
 
ExclusionCriteria 
Details  particpants who are under45 years and above and not willing to particpate in the study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
29 questions related to digital health literacy will be given to each particpant and the outcome will be determined using the data gathered from the questionaire   3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific intervention or endpoint criteria as this is an observational study focused on assessing digital health literacy.  3 weeks  
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
Final Enrollment numbers achieved (Total)= "422"
Final Enrollment numbers achieved (India)="422" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/02/2025 
Date of Study Completion (India) 03/02/2025 
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  

Aim:

       To access and understand the facilitators and barriers to digital health literacy among the ageing and elderly population of Udupi district, Karnataka.

Objectives:

       To identify the facilitators contributing to digital health literacy among the ageing and elderly in Udupi district

       To analyze the barriers hindering digital health literacy among the ageing and elderly population of Udupi district.

       To develop and provide a digital health literacy info graphics

Justification for study (whether of national significance with rationale) :

       Understanding facilitators is crucial for developingtargeted interventions that leverage existing strengths and resources, thereby effectively enhancing digital health literacy among the elderly. These facilitators can include community support, family assistance, or existing technological skills that, when identified and understood, can be harnessed to improve digital engagement and health outcomes.

       Identifying barriers allows for the development of strategies to address the specific inequities and challenges that prevent the elderly from accessing and utilizing digital health tools, thus ensuring that interventions are inclusive and effective. These barriers might include limited access to technology, lack of digital skills, or psychological resistance to new technologies, which need to be understood and mitigated to improve digital health literacy.

       Infographics provide a visually appealing and easy-to-understand format for conveying complex health information, making it more accessible for the elderly. By simplifying digital health concepts and providing clear, actionable steps, infographics can significantly enhance comprehension and engagement, leading to better adoption of digital health practices among the elderly.

       Departments involved :

OPD , Kasturba hospital Manipal, Karnataka

       Study period :

I year

Sample size :

Confidence level (Z)= I .96 for 95% confidence level Sample size :

Confidence level (Z) = I .96 for 95% confidence level

Margin of error (d) = 0.05 (or 5%)

Anticipated proportion of individuals with the outcome of interest (p) = assumed to be 0.5 (50%) as we assumed equal proportions between rural and urban areas initially.

Using the formula for estimating sample size in a cross-sectional study:

n Z2 xpx(I-p) / d2 n = (1.96)2xo.5x(1-o.5) / (0.05)2 n 3.8416xo.25 / 0.0025 n = 0.9604/0.0025 n = 384.16 n = 384 + 10% of non responders and partial responders n = 384+38 422

Materials and methods:

a) Inclusion and exclusion criteria:

Inclusion criteria:

      Ageing and elderly population

      mentally and physically stable participants

      participants witling to the study.

Exclusion criteria:

      Participants who are not physically and mentally stable

      Inpatients or hospitalized patients

      Individuals who are not willing to participate

Biological materials required (type - blood, tissue etc and quantity)

Nil

Statistical methods:

Descriptive variables analyzed using descriptive statistics, mean, frequency tables, graphs, percentage, proportion. Categorical variables analyzed using Chi-square test. Univariate analysis will be done to identify variables with p value less than 0.1 , variables with p < 0.1 will be included in a multiple linear regression model to perform adjusted analysis. Statistical analysis done using Jamovi version 2.3.28

Tools used:

Predesigned and validated e-heal questionnaires, which were previously used for a similar kind of study witl be used. We have email permission from the author to reuse the same questionnaire and use it by translating it into Indian local languages. And, a questionnaire with socio demographic data will be given

The eHEALS, or eHeaIth Literacy Scale, consists of 8 items, each evaluated on a 5-point Likert scale, where responses range from 1 to 5. The total possible score ranges from 8 to

40. A score exceeding 20 is considered indicative of good digital health literacy.

Detailed description of procedure processes:

I. The study will be a cross-sectional survey using the translated and validated eHEALS Survey tools to evaluate Digital Health Literacy. Permission to use this questionnaire has been secured.

2. Another questionnaire will collect socio-demographic data and identity factors affecting

Digital Health Literacy. It will be translated from English to Kannada, back-translated to Engtish, and then translated again to Kannada, involving translators for these processes.

3. The Informed Consent and Participant Information Sheet will also be translated into Kannada.

4. The study will receive approval from the Institutional Ethics Committee (IEC).

5. Participants will be recruited through ethical approval, direct approachwherepurpose the survey will be explained.

6. The survey will target individuals who are aged and elderly, who vis its Kasturba hospital and who are wilting to participate and provide consent.

7. Convenient sampling will be employed until the required sample size is reached.

8. Participants witl give written informed consent for the study.

9. Each participant will be assigned a unique code, ensuring their confidentiality and data

10.        Participants will complete a self-administered questionnaire, with assistance available to explain its contents if needed.

11.        Every participant will receive a printed infographic in Kannada about digital health literacy, covering both sides of the paper, focusing on managing misinformation, how to identify credible health information and to understand risks of misinformation.

OUTCOME MEASURES:

The key outcome measures for an exploratory study on the facilitators and barriers to digital health literacy among the aging and elderly population in the Udupi district of India could include:

     Number and type of facilitators identified that significantly enhance digital health literacy among the elderly in Udupi district

     The extent and nature of barriers quantified that impede digital health literacy among the elderly in Udupi district.

     The percentage of elderly individuals reporting improved understanding and usage of digital health tools after exposure to the infographics.

 
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