This study shall be a two-armed Randomized Controlled Trial conducted in a tertiary care setting, with the participants' randomization in an allocation ratio of 1:1 in two arms. The intervention will be implemented for three months and followed up for 12 months.
Study setting and participants
The interested participants fulfilling the eligibility criteria from four departments, i.e., (Cardiac, Pulmonary Medicine, ENT, and Neurology) of a tertiary care hospital in North India, shall be recruited simultaneously for the trial.
Inclusion criteria
Participants will be eligible provided they are
- above 18 years of age,
- using tobacco for the last one month and a history of using at least ten pack-year equivalent tobacco,
- able to read and understand English, Hindi, or Punjabi,
- have a mobile phone and active WhatsApp user for at least four days in the week,
- willing to be part of the study and provide verbal consent for intervention and follow up of 12 months
Exclusion criteria
Participants shall not be included if they are
- unable to understand any of the languages mentioned above,
- severely ill or having a mental illness (major depressive or psychotic disorder),
- already taking treatment for tobacco cessation,
- not willing to provide consent of follow-up for 12 months.
Informed Consent
The participants complying with the eligibility criteria will be informed about the study. Consent for inclusion in the study will be taken on an informed consent form in three languages like English, Hindi, and Punjabi, according to the preference. While in case of any harm or worsening of the disease, no compensation will be provided to the participants in the study.
Randomization
Stratified block randomization for participants in four departments will randomly allocate into either of the two intervention arms. For the balanced representation in two arms, block randomization with a block size of four will be used for allocation in two arms. Participants will be blinded to the randomization sequence; however, the researcher will not be blinded to the intervention considering the study's nature. Participant's allocation will be concealed until the pre-generated random sequence for allocation is opened. The contamination bias will also be reduced as the intervention shall be provided on one to one basis.
Intervention:
Brief Intervention
Participants in the brief intervention arm shall receive a (15-20-minutes) face-to-face individualized counseling session by the researcher at baseline. Along with standard care, participants shall also receive an information leaflet and a video for motivation. The information shall cover the harmful effects of tobacco use on health and the benefits and importance of quitting for motivation of the participants.
Intensive intervention
A brief intervention intended to enhance self-efficacy and motivation for quitting will be supported with other modalities in the intensive intervention arm. The supportive modalities include text messages and telephone counseling to increase the chances of quitting. Besides, it shall also provide information to support family and friends during quitting process; tips including coping with cravings, avoiding triggers, and distracting one's mind from tobacco use. These shall be provided through text and WhatsApp messages every week and telephone counseling for (5-10 minutes) after every 15 days for the next three months.
The researcher providing counseling shall be trained and supervised by a master-level clinical psychologist. The details of the intervention are in Figure 2.
Data collection:
The researcher will collect data from tobacco users enrolled in the study after fulfilling the inclusion criteria divided into two arms based upon the stratified block randomization technique. Baseline assessment will include tobacco use history, daily tobacco consumption, age of initiation, quit attempts, and treatment for cessation. While knowledge, attitude, and practices about tobacco use, nicotine dependence using FTND scale26 at each follow-up period, and subgroup analysis by the level of nicotine dependence shall also be collected. Further self-reporting shall be done for 7-day point prevalence and continuous tobacco abstinence at each follow-up period. While urine sample to biochemically confirm the cotinine presence shall be collected at the end of follow-up.
Measures:
Table 1: Data collection items and schedule
*FTND: Fagerstrom Tobacco Nicotine Dependence
**7DPPA: 7 day Point Prevalence Abstinence
Outcome measures:
Primary outcome
• Validated 7-day point prevalence tobacco abstinence at 12 months
Secondary outcomes
Measures at follow-up period 1, 3, 6 & 12 months:
- Self-reported continuous tobacco abstinence (between quit date and at each follow-up period at 1, 3, 6 & 12 months)
- Self-reported 7-day point prevalence tobacco abstinence (abstinence for continuous seven days just before at each follow-up period)
- Self-reported tobacco use reduction at each follow-up period
- Progression in the stage of behavior change
- Scores level of Nicotine dependence by FTND instrument
- Number of quit attempts and relapses within 12 months
- Change in knowledge, attitude, and practices score after intervention
Sample Size:
Based on existing literature where tobacco abstinence rate of 14.7% and 26.7% has been reported in control and intervention arm respectively, alpha level 0.05, 20% dropout rate, and power 0.90 (90%), the total sample size 574 will be enrolled. Participants shall be assigned into two arms at a ratio of 1:1 with 287 in each arm. The trial with this sample size will have sufficient power to detect a clinically significant difference between the two arms. The planned sample size shall be recruited in approximately 6 months and followed up for 12 months.
Statistical analysis:
The data obtained shall be entered and analyzed using Statistical Package for Social Science 22.0 software (IBM, SPSS, Inc). The difference in primary and secondary outcomes between two arms, using multiple logistic regression will determine the intervention's effect. The adjusted and unadjusted p values & odds ratio will be reported along with the confidence interval. All analysis will be conducted using intention to treat principles by controlling for potential confounders and using a conventional significance level of 0.05 to reject the null hypothesis.