| 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
|
|
|
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
|
|
|
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.
|