CTRI Number |
CTRI/2018/11/016421 [Registered on: 26/11/2018] Trial Registered Prospectively |
Last Modified On: |
21/11/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
To assess the quality of life in a patient with lung Tuberculosis in whom the routinely used drugs are not effective and to assess the difficulties faced by them to take medicines for the same also to check if the people living with them have any positive symptoms of lung Tuberculosis. |
Scientific Title of Study
|
Assessment of Health Related Quality of life in drug resistant tuberculosis patients and the challenges to drug adherence with symptomatic screening for active pulmonary tuberculosis infection among these patients and their household residents. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Aravindh kumar |
Designation |
Post-Graduate |
Affiliation |
Kasturba Medical College,Manipal Academy of Higher Education, Manipal. |
Address |
Department of Community Medicine, Kasturba Medical
College,Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
Udupi KARNATAKA 576104 India |
Phone |
9487426713 |
Fax |
|
Email |
aravindhmbbs2323@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pawan Kumar |
Designation |
Professor |
Affiliation |
Kasturba Medical College,Manipal Academy of Higher Education, Manipal. |
Address |
Department of Community Medicine, Kasturba Medical
College,Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
Udupi KARNATAKA 576104 India |
Phone |
9945272261 |
Fax |
|
Email |
pawan.kumar@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Eshwari K |
Designation |
Tutor |
Affiliation |
Kasturba Medical College,Manipal Academy of Higher Education, Manipal. |
Address |
Department of Community Medicine, Kasturba Medical
College,Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
Udupi KARNATAKA 576104 India |
Phone |
9880460083 |
Fax |
|
Email |
eshwari.k@manipal.edu |
|
Source of Monetary or Material Support
|
Will be applying for ICMR funding,Indian Council of Medical Research, V Ramalingaswami
Bhawan,Ansari Nagar,New Delhi-110029
|
|
Primary Sponsor
|
Name |
Kasturba Medical College Manipal |
Address |
: Kasturba Medical College, Manipal Academy of Higher
Education,Madhav Nagar, Manipal, Udupi, Karnataka 576104
|
Type of Sponsor |
Private medical college |
|
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 Aravindhkumar |
KASTURBA MEDICAL COLLEGE |
Department of
Community
Medicine,3rd
floor,KMC , Manipal
Academy of Higher
Education,Madhav
Nagar,Manipal. Udupi KARNATAKA |
9487426713
aravindhmbbs2323@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee-Kasturba Hospital Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
1.Health related quality of life of drug resistant TB patients
2.Drug adherence
3.Symptomatic screening for active TB infection among patients and their residents
|
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. All drug resistant tuberculosis patients (>18 years) registered under RNTCP Udupi district and have completed treatment or were declared cure at least one month before the time of visit.
2. All the family members residing with the patient
|
|
ExclusionCriteria |
Details |
Patients on treatment for drug resistant tuberculosis at the time of visit.
2. Patients unwilling to participate in the study
3. DR TB patients who are non- residents of Udupi district
4. Patients who are non-traceable
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Assess the each domain in health related quality of life using SF 36 Health related quality of life questionnaire
|
18 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
symptomatically positive status for TUBERCULOSIS among PATIENTS and HOUSEHOLD RESIDENTS will be assessed using symptomatic screening questionnaire and also assessed for DRUG ADHERENCE. |
18 months |
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
20/12/2018 |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The approval of the Institutional Ethics committee will be obtained to
conduct the study. After obtaining permission from the district tuberculosis
officer the TB register at District tuberculosis office (DTO) will be referred
and the list of eligible patients registered under RNTCP Udupi district from
2013 onwards will be obtained and their TB register numbers will be collected.
Also the DTO will be requested to share the information about the DR TB
patients with the respective PHC Medical officer and the respective area ANM.
With the help of ANM the patients will be traced and visited. Patient details
will be obtained from PHC. The subject who are non-traceable will be excluded
from the study. A face to face interview
will be conducted using a pre tested semi structured questionnaire to gather
the information regarding socio demographic characteristics, treatment and
follow up details and substance abuse after obtaining written informed consent.
The confidentiality about the identity and the information collected will be
ensured. The HRQoL of the patients will be assessed using SF-36, a validated
questionnaire and also the information regarding the challenges towards drug
adherence during their course of therapy will be collected followed by
symptomatic screening of patients and available household contacts for Chest
pain , Cough with expectoration ,Coughing up blood ,Fever, Loss of appetite
,Unexplained weight loss. Symptomatically positive subjects referred to the
nearest Designated Microscopy Centre (DMC) for further evaluation. The
evaluation status of symptomatically positive patients will be confirmed
telephonically from the respective Primary Health Centre. Patients who are not
available at the time of first visit for interview will be given second visit
and patient who is unavailable even at the time of second visit will be termed
as non-respondents. The information about subjects who have died post
completion of treatment due to any cause will be obtained from the respective
PHC medical officer and the household members will be contacted and will be
screened symptomatically. |