跳至主要内容
临床试验/CTRI/2018/11/016421
CTRI/2018/11/016421尚未招募不适用

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.

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
试验地点
1
主要终点
Assess the each domain in health related quality of life using SF 36 Health related quality of life questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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
  • Patients who are non-traceable.

结局指标

主要结局

Assess the each domain in health related quality of life using SF 36 Health related quality of life questionnaire

时间窗: 18 MONTHS

次要结局

  • 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)

研究者

申办方类型
Private medical college

研究点 (1)

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