| CTRI Number |
CTRI/2024/02/063109 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the stigma, the encouraging and the discouraging factors associated with the treatment and follow up in people affected with Tuberculosis in a district of Coastal Karnataka |
|
Scientific Title of Study
|
A study of the Stigma, Barriers, and Facilitators associated with Treatment and Follow-up of Tuberculosis Patients 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 |
Dr Yash Alok |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Community Medicine
3rd Floor
Biochemistry Building
Kasturba Medical College
MAHE
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105454973 |
| Fax |
|
| Email |
yash.alok@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yash Alok |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Community Medicine
3rd Floor
Biochemistry Building
Kasturba Medical College
MAHE
Madhav Nagar
Manipal
KARNATAKA
576104
India |
| Phone |
8105454973 |
| Fax |
|
| Email |
yash.alok@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yash Alok |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Community Medicine
3rd Floor
Biochemistry Building
Kasturba Medical College
MAHE
Madhav Nagar
Manipal
KARNATAKA
576104
India |
| Phone |
8105454973 |
| Fax |
|
| Email |
yash.alok@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr. Yash Alok |
| Address |
Department of Community Medicine
3rd Floor Biochemistry building
Kasturba Medical College
MAHE
Madhav Nagar Manipal |
| 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 Yash Alok |
Kasturba Medical College, Manipal |
Department of Community Medicine, 3rd floor, Biochemistry Building, Kasturba Medical College, MAHE
Madhav Nagar, Manipal,Udupi, Karnataka-576104
Udupi
KARNATAKA |
8105454973
yash.alok@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 |
| Patients |
(1) ICD-10 Condition: A15||Respiratory tuberculosis, (2) ICD-10 Condition: A17||Tuberculosis of nervous system, (3) ICD-10 Condition: A18||Tuberculosis of other organs, (4) ICD-10 Condition: A19||Miliary tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients greater than 18 years of age who are residing in Udupi and currently taking treatment for tuberculosis in Udupi district. |
|
| ExclusionCriteria |
| Details |
a.Pediatric age group (1-17 years of age)
b.Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. TB Stigma Score of patients
2. Number and types of barriers and facilitators in TB treatment seeking |
The outcomes will be calculated after the telephonic interview with the patient and will be summed up at the end of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/04/2024 |
| 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="1"
Months="0"
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
|
In India, stigma associated with Tuberculosis is
one of the key factors that influences the time taken by a patient to start and
continue their treatment. This may
indirectly/directly affect the treatment outcome of the disease as well. Also,
the exploration of the barriers and facilitators of treatment seeking in
patients will help to direct efforts towards efficient delivery of health care.
This study will help to identify the degree of stigma that patients with
tuberculosis face in the region and explore the factors that prevent/delay
treatment seeking and/or follow-up and factors that motivated patients for
seeking treatment and/or follow up for tuberculosis. |