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.

Not yet recruiting

Conditions: 1.Health related quality of life of drug resistant TB patients2.Drug adherence3.Symptomatic screening for active TB infection among patients and their residents

Registration Number: CTRI/2018/11/016421

Lead Sponsor: Kasturba Medical College Manipal

Brief Summary: The approval of the Institutional Ethics committee will be obtained toconduct the study. After obtaining permission from the district tuberculosisofficer the TB register at District tuberculosis office (DTO) will be referredand the list of eligible patients registered under RNTCP Udupi district from2013 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 TBpatients with the respective PHC Medical officer and the respective area ANM.With the help of ANM the patients will be traced and visited. Patient detailswill be obtained from PHC. The subject who are non-traceable will be excludedfrom the study. A face to face interviewwill be conducted using a pre tested semi structured questionnaire to gatherthe information regarding socio demographic characteristics, treatment andfollow up details and substance abuse after obtaining written informed consent.The confidentiality about the identity and the information collected will beensured. The HRQoL of the patients will be assessed using SF-36, a validatedquestionnaire and also the information regarding the challenges towards drugadherence during their course of therapy will be collected followed bysymptomatic screening of patients and available household contacts for Chestpain , Cough with expectoration ,Coughing up blood ,Fever, Loss of appetite,Unexplained weight loss. Symptomatically positive subjects referred to thenearest Designated Microscopy Centre (DMC) for further evaluation. Theevaluation status of symptomatically positive patients will be confirmedtelephonically from the respective Primary Health Centre. Patients who are notavailable at the time of first visit for interview will be given second visitand patient who is unavailable even at the time of second visit will be termedas non-respondents. The information about subjects who have died postcompletion of treatment due to any cause will be obtained from the respectivePHC medical officer and the household members will be contacted and will bescreened symptomatically.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the each domain in health related quality of life using SF 36 Health related quality of life questionnaire	18 MONTHS

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): KASTURBA MEDICAL COLLEGE
🇮🇳
Udupi, KARNATAKA, India
KASTURBA MEDICAL COLLEGE
🇮🇳Udupi, KARNATAKA, India
Dr Aravindhkumar
Principal investigator
9487426713
aravindhmbbs2323@gmail.com