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Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354638
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Gauravi Ashish Mishra, Tata Memorial Hospital

Tracking Information
First Submitted Date  ICMJE December 11, 2014
First Posted Date  ICMJE February 3, 2015
Last Update Posted Date April 30, 2018
Study Start Date  ICMJE December 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Knowledge, Attitude & practice (change in the baseline KAP) [ Time Frame: 30 months ]
a) The
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02354638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers) [ Time Frame: 30 months ]
    b) The perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
  • Oral cancer detection by oral screening [ Time Frame: 30 months ]
    c)The results of oral cancer screening in the form of oral pre-cancers and cancers detected
  • Quit rates (self reported quit rates) [ Time Frame: 30 months ]
    d) The success of tobacco cessation programme in the form of self reported quit rates at the end of one year
  • Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions) [ Time Frame: 30 months ]
    e) Reactions of the commuters and their own perceptions towards the no tobacco messages conveyed to the customers while traveling
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai
Official Title  ICMJE Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai, India
Brief Summary

In addition to the passengers smoking inside the cab, the taxi drivers,are themselves addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness of the cab drivers with respect to the hazards of tobacco and significance of the smoke free legislation.

It's been six years since the implementation of rules prohibiting smoking in public places and a re-look at the compliance to this regulation is necessary. The study will also help tobacco users to quit their habits. They will get screened for oral premalignant and malignant lesions.

Also, the cab drivers may pass on some effective messages regarding importance of keeping oneself away from tobacco, to the customers while commuting. In view of the above background, the current study is proposed to look at all these aspects.

The findings of the study will be certainly generating useful information with regards to lacunae in the existing system for appropriate implementation and for strengthening anti tobacco advocacy in our country.

Detailed Description

AIM and OBJECTIVES:

  1. To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco and smoke free public places among cab drivers ferrying customers near Tata Memorial Hospital
  2. To study the impact of smoke free public places with specific reference to smoke free cabs (on various factors such as number of customers, customer practices, health status, self practices, compliance etc.)
  3. To understand their attitude towards smoke free cabs.
  4. To educate them regarding hazards of tobacco and the need for smoke free cabs.
  5. To invite the cab drivers using tobacco to avail the Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
  6. To evaluate the compliance for availing the services
  7. To study the post-intervention KAP regarding tobacco and smoke free public places
  8. To determine the rate of oral pre-cancers and tobacco cessation after one year follow-up.

Methodology:

Design: Single arm interventional study

Step 1: Around 400 cab drivers in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed with the help of a well structured questionnaire to collect information about their Knowledge, Attitudes and Practices (KAP) regarding tobacco, their attitudes and experiences regarding smoke free public places with specific reference to smoke free cabs.

Step 2: The cab drivers will be given detailed health education regarding hazards of tobacco and the need for smoke free cabs. They will be invited to participate in oral cancer screening at the Preventive Oncology (PO) screening clinic.

Step 3: The cab drivers will be again interviewed with the help of a well structured questionnaire to collect information of their post-intervention KAP regarding tobacco and smoke free public places.

Step 4: The cab drivers using tobacco will be invited to participate in the tobacco cessation programme at the TCC and will receive three monthly follow-up for one year. Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used. In addition they will be engaged in conveying messages about tobacco control and refraining from tobacco habit, to the customers while commuting. This will also reinforce their own commitment towards tobacco cessation.

Variables to be estimated:

  1. the change in the baseline KAP
  2. the perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
  3. the results of oral cancer screening in the form of oral pre-cancers and cancers detected
  4. the success of tobacco cessation programme in the form of self reported quit rates at the end of one year
  5. reactions of the commuters and their own perceptions towards the no tobacco messages conveyed to the customers while traveling

Data Analysis:

Data entry will be done in the Department of Preventive Oncology, Tata Memorial Hospital using SPSS version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE Compliance
Intervention  ICMJE
  • Behavioral: Tobacco users
    Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used in the tobacco users.
  • Drug: Pharmacotherapy

    Pharmacotherapy will also be prescribed as per the need assessment consisting of:

    Nicotine Chewing Gums:

    Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings.Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months

    Nicotine Transdermal patches:

    Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks

    Other Name: Nicotine replacement therapy
Study Arms  ICMJE
  • Experimental: Tobacco users: behavioural counseling
    The cab drivers using tobacco will be invited to participate in the tobacco cessation programme at the TCC and will receive three monthly follow-up for one year. Thus intervention will be in the form of behavioural therapy and pharmacotherapy (if required)
    Interventions:
    • Behavioral: Tobacco users
    • Drug: Pharmacotherapy
  • No Intervention: Non Users
    The cab drivers who are not using tobacco in any form will not receive any type of intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 400 Cab drivers ferrying customers near Tata Memorial Hospital on a regular basis

Exclusion Criteria:

  • Any Cab drivers outside the category as mentioned in the proposal
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02354638
Other Study ID Numbers  ICMJE TMHPOCAB2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gauravi Ashish Mishra, Tata Memorial Hospital
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gauravi A Mishra, Assoc Prof Tata Memorial Hospital, Mumbai
Principal Investigator: Sharmila A Pimple, Professor Tata Memorial Hospital, Mumbai
PRS Account Tata Memorial Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP