Effect of brief advice on abstinence from smoking in patients with tuberculosis and non-communicable diseases

Not yet recruiting

Conditions: Tuberculosis, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, (3) ICD-10 Condition: E08-E13||Diabetes mellitus,

Registration Number: CTRI/2017/10/009985

Lead Sponsor: AIIMS New Delhi

Brief Summary: This is a randomized controlled trial which will be conducted at the Comprehensive Rural Health Services Project (CRHSP) hospital, Ballabgarh in Faridabad district of Haryana, India. This is a secondary level hospital and caters to more than three hundred thousand patients every year and has specialized non-communicable diseases clinic as well as is a Tuberculosis Unit under Revised National Tuberculosis Control Programme. A total of 650 subjects with tuberculosis and NCDs (hypertension or diabetes) each will be recruited consecutively from the outpatient department. All subjects will be administered a questionnaire to assess tobacco use and Fagerstrom test for nicotine dependence will be used to assess nicotine dependence among those who smoke. 100 smokers each from the tuberculosis group and the NCD group will be recruited in the trial. They will be randomly assigned separately to either intervention or control arm. Intervention will include brief tobacco cessation advice administered at monthly interval for six months by the physician in the outpatient clinic. Control arm will consist of routine care. Primary outcome will be abstinence from tobacco use at six month as measured by carbon monoxide exhalation measured using breath analyzer. Self-reported abstention from tobacco use will also be assessed and its correlation with exhaled carbon monoxide will be assessed. Proportion of subjects in both groups who attain abstinence from tobacco use will be measured and chi-square test will be used to assess the significance of difference in proportion of subjects who attained abstinence from tobacco smoking in both groups. Secondary outcome for tuberculosis patients will include treatment outcomes (time to sputum conversion, default, success, death). Qualitative methods will also be used to assess the challenges in integrating brief tobacco advice in routine health care delivery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Adult patients with 18 years or more with one of three diagnosed condition; pulmonary tuberculosis, hypertension and diabetes and who smokes tobacco.

Exclusion Criteria

Patients who are not able to comprehend the questionnaire/intervention or not willing to give consent 2.
patients with substance abuse disorder.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abstinence from tobacco smoking	6 months

Secondary Outcome Measures

Name	Time	Method
Treatment outcome in pulmonary tuberculosis patients	6 months

Trial Locations

Locations (1): Comprehensive Rural Health Services Project (CRHSP) Hospital, Ballabgarh
🇮🇳
Faridabad, HARYANA, India
Comprehensive Rural Health Services Project (CRHSP) Hospital, Ballabgarh
🇮🇳Faridabad, HARYANA, India
Dr Rakesh Kumar
Principal investigator
drrakesh@hotmail.co.uk