FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
Close