| CTRI Number |
CTRI/2025/09/094298 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Awareness and practices regarding digital health literacy: An interventional study |
|
Scientific Title of Study
|
A STUDY OF IMPACT OF HEALTH INFORMATION EDUCATION ON AWARENESS AND PRACTICES REGARDING DIGITAL HEALTH LITERACY AMONG OPD PATIENTS IN A TERTIARY CARE HOSPITAL |
| 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 Namit Sarkar |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli |
| Address |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli 416415
Sangli
MAHARASHTRA
416415
India |
| Phone |
9330742611 |
| Fax |
|
| Email |
namitsarkar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Baliram Waghachavare |
| Designation |
Professor Department of Community Medicine |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli |
| Address |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli 416415
Sangli
MAHARASHTRA
416415
India |
| Phone |
8830483862 |
| Fax |
|
| Email |
vivek416416@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namit Sarkar |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli |
| Address |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli 416415
Sangli
MAHARASHTRA
416415
India |
| Phone |
9330742611 |
| Fax |
|
| Email |
namitsarkar2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Namit Sarkar |
| Address |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli 416415 |
| 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 Namit Sarkar |
Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli OPD. |
Bharati hospital OPD sangli Maharastra 416415.
Sangli
MAHARASHTRA |
9330742611
namitsarkar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed To Be University Medical College And Hospital Sangli OPD. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital health literacy with the help of digital health tools. |
STEP-1 At first meet the patients outside the OPD.
STEP-2 Discuss with the participant in detail about the dissertation study.
STEP-3 Explain him/her about the entire process and how I shall conduct the study.
STEP-4 Take consent from the participant in a separate consent form.
STEP-5 Do the pretest appropriately.
STEP-6 After pretest I will explain the participants through Powerpoint presentation, flowcharts and explanations regarding digital health tools.
STEP-7 Immediately conduct post test.
STEP-8 After 1 month again conduct second post test physically if available or on phones.
STEP-9 Analyze the results.
|
| Comparator Agent |
digital health tools awareness |
STEP-1 At first meet the patients outside the OPD. STEP-2 Discuss with the participant in detail about the dissertation study. STEP-3 Explain him/her about the entire process and how I shall conduct the study. STEP-4 Take consent from the participant in a separate consent form. STEP-5 Do the pretest appropriately. STEP-6 After pretest I will explain the participants through Powerpoint presentation, flowcharts and explanations regarding digital health tools. STEP-7 Immediately conduct post test. STEP-8 After 1 month again conduct second post test physically if available or on phones. STEP-9 Analyze the results. Edit || Delete
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients aged>18 years attending the tertiary care hospital OPD
2.All patients who are willing to participate and providing informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients who are critically ill or mentally challenged
2.Patients having major psychiatric illness, intellectual disability, illiterate person.
3.Patients who are not willing to participate and do not provide informed consent.
lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is an improvement in the awareness and practices related to digital health tools after the health education intervention among patients. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="223"
Sample Size from India="223"
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)
|
20/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - In dissertation as per university and ugc guidelines
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - dissertation after publication is available online as per the university guidelines
|
|
Brief Summary
|
Digital health literacy (DHL) is the ability to find, understand, and use information and services from electronic sources to make informed health decisions. It involves using digital technologies to access, comprehend, and apply health information, ultimately improving an individual ability to manage their health and participate in their own healthcare. · Parameters that will be considered under digital health literacy: knowledge about these tools. Digital health tools 1. Teleconsultation apps (eSanjeevani, practo, felicity etc.) 2. Health tracking apps (BP, Sugar, Step counters) 3. Wearable devices (smart watch, fitness bands, fitness rings) 4. Online pharmacies (1mg, pharmeasy, amazon, apollo, netmeds etc) 5. ABHA Health ID/ health locker. 6. Online appointment booking system. 7. Authorized websites for health information. STEP-1 At first meet the patients outside the OPD. STEP-2 Discuss with the participant in detail about the dissertation study. STEP-3 Explain him/her about the entire process and how I shall conduct the study. STEP-4 Take consent from the participant in a separate consent form. STEP-5 Do the pretest appropriately. STEP-6 After pretest I will explain the participants through Powerpoint presentation, flowcharts and explanations regarding digital health tools. STEP-7 Immediately conduct post test. STEP-8 After 1 month again conduct second post test physically if available or on phones. STEP-9 Analyze the results. |