| CTRI Number |
CTRI/2025/10/096160 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Qualitative Ethnographic |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Support Systems among diabetic patients in Bengaluru district India |
|
Scientific Title of Study
|
Investigating perceptions of diabetic adult patients and their networks towards social support in diabetes management in Bengaluru district India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharanya Sriram |
| Designation |
Fulbright-Nehru Student Researcher |
| Affiliation |
St. Johns Research Institute |
| Address |
Floor 2 Museum Block Division of Health and Humanities
Bangalore
KARNATAKA
560034
India |
| Phone |
9741980240 |
| Fax |
|
| Email |
sharanyasriram123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharanya Sriram |
| Designation |
Fulbright-Nehru Student Researcher |
| Affiliation |
St. Johns Research Institute |
| Address |
Floor 2 Museum Block Division of Health and Humanities
KARNATAKA
560034
India |
| Phone |
9741980240 |
| Fax |
|
| Email |
sharanyasriram123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharanya Sriram |
| Designation |
Fulbright-Nehru Student Researcher |
| Affiliation |
St. Johns Research Institute |
| Address |
Floor 2 Museum Block Division of Health and Humanities
KARNATAKA
560034
India |
| Phone |
9741980240 |
| Fax |
|
| Email |
sharanyasriram123@gmail.com |
|
|
Source of Monetary or Material Support
|
| United States-India Educational Foundation.
12 Hailey Road New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
United States-India Educational Foundation |
| Address |
Fulbright Commission in India
12 Hailey Road
New Delhi 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Manjulika Vaz |
St Johns Research Institute |
FLOOR 2, Museum Block, Division of Health and Humanities,Sarjapura Road Banglore 560034
Bangalore
KARNATAKA |
9845727821
manjulikavaz@sjri.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Johns Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Without Type 2 Diabetes Mellitus history |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.90 Year(s) |
| Gender |
Both |
| Details |
Men and women aged 18 to 100 with an established diagnosis of type 2 diabetes mellitus for a minimum of three months
Men and women aged 18 to 100 without an established diagnosis of type 2 diabetes mellitus but directly identified by an adult diabetic patient as an important member of their extended support network
Individuals across a broad range of socioeconomic status as defined by occupational status income, or education level
Individuals living in rural peri-urban, and urban settings
Individuals with a range of beliefs regarding and adherence to AYUSH medicine (from high adherence to non-adherent) to explore cultural and health-seeking behavior dimensions |
|
| ExclusionCriteria |
| Details |
Individuals unable to communicate effectively in the primary languages of data collection Kannada,Tamil,English Individuals with mild, moderate, or severe cognitive impairment or history of unmanaged psychiatric disorder which may interfere with informed consent or reliable participation in interviews or observations
Individuals with significant hearing impairment that may affect their ability to engage in interviews or group discussions, unless appropriate accommodations can be made Individuals with acute illness on day of data collection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the barriers and facilitators of social support among adult diabetic patients and their networks, examining the influence of gender roles, rural-urban differences, and traditional health beliefs on the receipt and provision of support, to inform the development of culturally responsive tools for measuring social support in diabetes care. |
To be obtained over the course of nine months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/12/2025 |
| 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="0"
Months="9"
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
|
India faces a growing diabetes crisis, with one in seven diabetic adults worldwide residing in the country. Socioeconomic disparities, particularly in rural areas, limit diagnosis and effective management, as diabetes care demands disciplined self-management and often disrupts daily life. Social support from family, peers, and communities can significantly alleviate this burden, yet little is known about how factors such as rural-urban context, gender, or belief in Ayurveda shape diabetic patients’ perceptions and reliance on support networks. This qualitative study seeks to fill that gap and support the development of culturally tailored tools to assess social support levels, ultimately informing more personalized care plans. Data will be collected through in-depth qualitative interviews with adult type 2 diabetic patients and their network members. Thematic coding will combine inductive insights with deductive themes like gender norms, holistic health beliefs, and urban-rural differences. Researcher reflexivity, debriefings, and field journals will ensure rigor and transparency. Preliminary findings will be validated through playback sessions with community stakeholders, allowing for iterative refinement. Final outputs include a peer-reviewed manuscript and academic poster to inform culturally responsive recommendations to enhance diabetes care in India and enable cross-cultural comparisons with patients in the U.S. |