| CTRI Number |
CTRI/2021/02/030962 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find health related behavior regarding eye diseases due to uncontrolled levels of sugar in Kodumur Taluk, Kurnool dist. |
|
Scientific Title of Study
|
A study on the knowledge, attitude and practice of health seeking behavior regarding diabetic retinopathy in Kodumur Taluk,Kurnool dist. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gallella Sushma Pragathi |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor,
Department: health policy, MPH Prasanna School of Public Health,MAHE,
Madhav Nagar, Udupi, Karnataka-576104.
Udupi
KARNATAKA
576104
India |
| Phone |
6304194534 |
| Fax |
|
| Email |
gsushmapragathi204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
LH-63,First floor,
Department: health policy, MPH
Prasanna School of Public Health, Madhav Nagar, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Gallella Sushma Pragathi |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor,
Department: health policy, MPH Prasanna School of Public Health, Madhav Nagar, Udupi, Karnataka-576104.
Udupi
KARNATAKA
576104
India |
| Phone |
6304194534 |
| Fax |
|
| Email |
gsushmapragathi204@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no: LH 63, Department: health policy, MPH Prasanna School of Public Health,MAHE,
Madhav Nagar, Udupi, Karnataka-576104. |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health |
| Address |
Room number 63, Prasanna School of Public Health, Madhav Nagar, Manipal, Udupi, Karnataka-576104 |
| Type of Sponsor |
Other [Private Institution of Education and Research] |
|
|
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 Sumit Kumar |
Prasanna School of Public Health |
LH-63,First Floor,department: health policy , MPH, Prasanna School of Public Health,MAHE,
Madhav Nagar, Udupi, Karnataka-576104., Udupi.
Udupi
KARNATAKA |
8867620088
kumar.sumit@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asha workers of kodumur taluk |
| Patients |
(1) ICD-10 Condition: E110||Type 2 diabetes mellitus with hyperosmolarity, (2) ICD-10 Condition: E111||Type 2 diabetes mellitus with ketoacidosis, (3) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (4) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (5) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (6) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (7) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (8) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Duration of diabetes for >1 year and <20 years with stable diabetic therapy within last 6 months.
Pregnant women with chronic diabetes |
|
| ExclusionCriteria |
| Details |
Presence of gestational diabetes mellitus.
Those unable to answer the questionnaire because of dementia, psychosis or profound deafness were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness of diabetic retinopathy in diabetic population in kodumur thalak, kurnool dist. |
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge and understanding of Asha workers to encourage more screening of diabetes |
six months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "187"
Final Enrollment numbers achieved (India)="187" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2021 |
| Date of Study Completion (India) |
10/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional study to assess the knowledge, attitude and practices of health seeking behavior in diabetic population in Kodumur Taluk, Andhra Pradesh. This study helps to identify the awareness and health seeking practices in rural population. The objectives are to assess the level of existing knowledge, attitude and practice on diabetic retinopathy in diabetics and in ASHA workers, The outcome of research project will provide the statistical data of health seeking behavior of diabetic population regarding diabetic retinopathy and awareness of diabetic retinopathy in ASHA workers , which enables the future researchers to conduct evidence based research. |