| CTRI Number |
CTRI/2024/12/078244 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How People with Diabetes in India Take Care of Themselves and Learn About Their Health in Different Cultures |
|
Scientific Title of Study
|
Health literacy and self-care behaviours in Indian diabetic patients: A study across cultural zones |
| 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 Revanth Jai Saran S |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8838963297 |
| Fax |
|
| Email |
revanth.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Rani |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8310214742 |
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Rani |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
KARNATAKA
576104
India |
| Phone |
8310214742 |
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal. |
|
|
Primary Sponsor
|
| Name |
Dr Revanth Jai Saran S |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 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 Revanth Jai Saran S |
Prasanna School of Public Health |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA |
8838963297
revanth.psphmpl2023@learner.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 |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a diagnosis of diabetes mellitus (Type 2)
Age 18 years and above
People who can read and comprehend the English language.
Indian nationals who are permanent residents of India. |
|
| ExclusionCriteria |
| Details |
Patients with severe cognitive impairment or mental health conditions that may affect their ability to participate
Patients who are unable to read or understand the questionnaire in English
Patients with Diabetes other than Type 2 Diabetes Mellitus.
Patients not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the co-relation between health literacy levels and the self-care behaviours of diabetic patients in different cultural zones of India |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the perception of the participant’s health literacy level regarding diabetes mellitus (type 2) |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="422"
Sample Size from India="422"
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)
|
28/12/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Aims & objectives: Aim: To investigate the relationship between health literacy and self-care behaviours among Indian diabetic patients across various cultural zones in India.
Objectives: 1. To assess the health literacy levels of diabetic patients in different cultural zones of India. 2. To evaluate the self-care behaviours of diabetic patients in these zones. 3. To examine the correlation between health literacy and self-care behaviours.
Detailed description of procedure/processes: The objective of the study has been established with specific inclusion and exclusion criteria. A sample size of 422 participants was determined using the appropriate formula. The study employs an online survey format incorporating two questionnaires, namely HLS-IND-Q16 and SDSCA, which have been combined. The HLS-IND-Q16 questionnaire focuses on various aspects of health literacy among diabetic patients, including access to health information, the ability to find reliable health information, and active health management. Each domain is scored independently, with higher scores indicating better health literacy. The SDSCA questionnaire assesses self-care behaviors related to diet, exercise, blood sugar testing, foot care, and medication adherence. Data collection will be conducted through multiple social media channels to ensure a diverse representation across cultural zones in India. Collected data will then be analyzed using Jamovi software, with correlation analysis between health literacy and self-care practices performed using the Spearman correlation coefficient. Subsequently, the results of the HLS-IND-Q16 and SDSCA assessments will be interpreted, highlighting differences in health literacy and self-care behaviors across different cultural zones. Finally, the study will discuss the implications of these findings for tailoring diabetes management strategies to diverse cultural contexts in India. Statistical methods: Descriptive statistics and Inferential statistics analysis
Tools used: Health Literacy Questionnaire (HLS-IND-Q16) Summary Diabetes Self-Care Activities Questionnaire (SDSCA) |