| CTRI Number |
CTRI/2025/10/095626 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge, preventive behavoiur towards Tuberculosis(TB) and readiness for Adult TB Vaccination |
|
Scientific Title of Study
|
A cross-sectional study to assess the knowledge, preventive behaviour towards Tuberculosis (TB) among patients with TB and their caregivers and readiness for adult TB vaccination among caregivers of patients with TB at selected health centers of Udupi Taluk, 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 |
Pritha Dhali |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
4th floor, Room no 400 A, Manipal College of Nursing, Manipal, Madhav Nagar
Manipal College of Nursing, Manipal, Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
6291197375 |
| Fax |
918202922572 |
| Email |
prithadhali12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashidhara YN |
| Designation |
Professor and HOD |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
4th floor, Room No 406B, Manipal College of Nursing, Manipal, Madhav Nagar
Manipal College of Nursing, Manipal, Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
6291197375 |
| Fax |
918202922572 |
| Email |
shashidhara.yn@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pritha Dhali |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
4th floor, Room No 400 A, Manipal College of Nursing
Manipal College of Nursing, Manipal, Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
6291197375 |
| Fax |
918202922572 |
| Email |
prithadhali12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| District Hospital Udupi, Ajjrakadu road, 576101 |
| Hirebettu PHC, Karnataka, 576107 |
| Hiriyadka PHC, Karanataka, 576113 |
| Kasturba Hospital, Madhav Nagar, Manipal, 576104 |
| Manipal UPHC, Vaishnavi Sabhabhavan, Udupi, Karkala Highway, Eshwar Nagar, Manipal, 576104 |
| Pernankila PHC, Udupi, 576113 |
|
|
Primary Sponsor
|
| Name |
Pritha Dhali |
| Address |
4th floor, Room No. 400A, Manipal College of Nursing, Manipal,Madhav Nagar |
| Type of Sponsor |
Other [Self-sponsored] |
|
|
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 |
| Pritha Dhali |
Manipal College of Nursing |
4th floor, Room No. 400A, Manipal College of Nursing, Madhav Nagar.
Udupi
KARNATAKA |
06291197375
prithadhali12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institute Ethics Committee- 2(Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of patients with TB |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who had a sputum test or X-ray to confirm their tuberculosis diagnosis during the last six months.
Patients who are diagnosed with both pulmonary and extrapulmonary tuberculosis at healthcare centres.
Patients who are taking anti-TB medications for the last six months.
caregivers who provide ongoing care for patients.
Immediate family members.
Caregivers who fulfil the criteria of adult TB vaccination as per (TB- WIN, 2024).
TB-positive patients and their caregivers who will be available during the time of data collection.
Participants who are willing to participate in the study and will sign the written informed consent.
Participants who can read and write Kannada/English.
|
|
| ExclusionCriteria |
| Details |
Patients who are not registered under the healthcare centres.
Patients with multidrug-resistance tuberculosis (MDR-TB).
Patients with HIV/TB coinfection condition.
TB-positive patients and caregivers of them who are aged below 18 years.
Caregivers are above 70 years.
Any paid caregiver.
Caregivers who are not living in the same house.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The responses obtained from the participants will be used in the development of educational material regarding Tuberculosis and its preventive behaviours including adult TB vaccination. |
Time point for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will further help in raising awareness & uptake of the adult TB vaccination among the population, thus reducing TB related morbidity & mortality. |
Six weeks time |
|
|
Target Sample Size
|
Total Sample Size="376"
Sample Size from India="376"
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)
|
12/01/2026 |
| 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 - NO
|
|
Brief Summary
|
A cross-sectional study to assess the knowledge, preventive behaviour towards
Tuberculosis (TB) among patients with TB
and their caregivers and readiness for adult
TB vaccination among caregivers of patients with TB at selected health
centre of Udupi Taluk, Karnataka.
The purpose of the study
is to understand the knowledge, preventive behaviour towards Tuberculosis (TB) and check the readiness of adult TB vaccination. The responses obtained
from the participants will be used in the development of educational material
regarding Tuberculosis and its preventive behaviours including adult TB
vaccination. It will further help in raising awareness and uptake of the adult
TB vaccination among the population, thus reducing TB related morbidity and
mortality.
The objectives of the study are to
assess the knowledge on tuberculosis among patients with TB and their
caregivers by using structured knowledge questionnaire, assess the preventive
behaviour towards tuberculosis among patients with TB and their caregivers by
using a structured rating scale, determine the readiness for adult TB
vaccination among caregivers of TB patients by using readiness Scale, find the
association between readiness for adult TB vaccination and selected demographic
variables like age, gender, educational level, employment, smoking
habit, alcohol consumption, place of residence and
received adult vaccinations.
The quantitative research approach with
descriptive, cross-sectional study. The research study will be conducted at
selected health centres of Udupi Taluk. The population of the study will be the
patients with TB and their caregivers of Udupi district. The sample is
calculated based on the previous study and the sample size is 188 patients and
188 caregivers.
The inclusion criteria are
the patients who had a sputum test or X-ray to confirm their tuberculosis
diagnosis during the last six months, who diagnosed with both pulmonary and
extrapulmonary tuberculosis at healthcare centres, who are taking anti TB
medications for last six months, caregivers who provide ongoing care for
patients, immediate family members, caregivers who fulfil the criteria of adult
TB vaccination as per TB WIN portal, TB positive patients and their caregivers
who will be available during the time of data collection, participants who are
willing to participate in the study and will sign the written informed consent,
participants who can read and write Kannada/English and exclusion criteria are
patients who are not registered under the healthcare centres, patients with
multidrug- resistance tuberculosis, patients with HIV/TB coinfection condition,
TB positive patients and caregivers of them who are aged below 18 years, caregivers
age above 70 years, any paid caregiver, and
caregivers who are not living in the same house.
The sample will be selected using purposive
sampling technique, and instrument for data collections are demographic & clinical
proforma for patient with TB, demographic & clinical proforma for
caregivers of patients with TB, Knowledge questionnaire on TB, TB preventive
behaviour rating scale for patient with TB, TB preventive behaviour rating
scale for caregivers of patients with TB, readiness Scale on Adult TB
vaccination.
The Validity of the tools
has established by five experts. The pretesting will be conducted among five TB
patients with their caregivers of selected healthcare centres. The reliability
of the tool will be established by administering to 20 TB patients with their
caregivers of selected healthcare centres.
The pilot study will be
conducted after obtaining formal permission from Dean and Institute research
committee of College of Nursing and District Tuberculosis Control Officer. The pilot study will be conducted in healthcare
center from those fulfilling the inclusive criteria and it will be done through
purposive sampling technique. Oral consent will be obtained from each of the TB
patients and their care givers
The data will be collected
after getting approval from ethical institutions. The data will be collected according
to the sampling criteria, after obtaining participant’s informed consent and
distributing participant information sheet. Data will be collected using self-administered
questionnaire.
The data will be analysed
using frequency tables and percentages, inferential statistics like ANOVA, Chi
square using Jamovi 2.3.28.
|