Evaluating the Impact of Culturally-Specific Patient-Centric Behavioral Intervention Package versus Usual care for Tobacco Cessation among Patients attending Non- Communicable Disease Clinics in North India: A Single-Blind Trial Pilot Study Protocol (Preprint)
Authors: BHATT GARIMA , GOEL SONU , GUPTA RAKESH , GROVER SANDEEP , MEDHI BIKASH 
Published: January 2021

BACKGROUND

In a low & middle-income country (LMIC) like India, non – communicable diseases (NCDs) contribute a major proportion (61.8%) of all causes of death. Out of this 48% of cardiovascular diseases (CVDs), 23% of Chronic Respiratory Diseases (CRDs), 10% of Cancer deaths are attributable to tobacco use. Tobacco use is a major risk factor for NCDs and thus, the tobacco cessation approach is a high priority intervention to combat complications and death among NCD patients. While there are several interventions available for tobacco cessation, in resource constraint country like India, the effectiveness of low cost, culturally specific patient-centric tobacco cessation behavioral intervention holds a potential which needs to be evaluated.

OBJECTIVE

In this study, a newly devised evidence-based tobacco cessation intervention package including a behavioral approach will be compared with the existing/usual care provided under the National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) at NCD clinics.

METHODS

Design: Two arm, parallel-group randomized controlled trial. Participants: Patients aged ≥ 30 years suffering from any NCD, currently using tobacco and attending NCD clinics in two districts of Punjab, India. Sample size: A total of 200 participants meeting the selection criteria will be recruited. They will be allocated either to the intervention arm or control (usual care) arm (100 each) using block randomization. Intervention: For the participants, there will be four face-to-face disease-specific cessation counseling sessions, disease-specific pamphlets, short text messages in vernacular language i.e, Punjabi. Follow-ups will be done at the 3rd, 6th, 9th, and 12th months. Primary outcome: Seven-day abstinence, biochemically verified by plasma cotinine levels. Secondary outcome: Quit attempts, number of sticks/number of times of SLT usage in a day, and stage of behavior change in tobacco user.

RESULTS

This multi-component culturally specific- patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings with a focus on the individual, family, and social environment could increase the outreach of cessation services using existing resources thereby strengthening health systems and improving the quality of life of NCD patients.

CONCLUSIONS

This multi-component culturally specific- patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings with a focus on the individual, family, and social environment could increase the outreach of cessation services using existing resources thereby strengthening health systems and improving the quality of life of NCD patients.

CLINICALTRIAL

The study protocol is registered with Clinical Trials Registry, India. The registration number is CTRI/2018/01/011643.