AzTrials
AzTrials

ComplianceNCT02363257

Smoke Free Policy Among BEST Bus Employees and Commuters in Mumbai

An observational study of Compliance, run by Tata Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Three years since the Smoke Free Mumbai campaign and six years since the ban on smoking in public places was implemented. It is necessary to review the situation at this point in time so that corrective actions if necessary can be taken. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Compliance
How many people
1,025 participants
Where
No sites listed yet
Study dates
Jun 2015to Feb 2017
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: BEST Employees, Regular BEST commuters, Stakeholders:1.BEST Committee members 2.Important people in the managerial and administrative cadre in authoritative positions who can influence tobacco policy 3.Members of Employee Unions within the organization 4.Medical Unit including - Chief Medical Officers, Junior and Senior Medical Officers, Paramedical workforce 5.BEST Commuters Forum 6.Personnel in authoritative positions in: G. M. office 7.Welfare Department 8.Personnel Department 9.PRO Department 10.Legal Department 11.BEST Commuters 12.Any other stakeholders eventually identified

Who may be able to join

  • BEST employees (Bus drivers, Bus conductors and ticket checkers) and regular BEST commuters (>18 years) in Mumbai will be invited to participate in the study.

Who cannot join

  • BEST employees and Commuters refusing to participate.

Trial locations and contacts

No sites are listed yet.

Dr. Sharmila A Pimple, MD contact

+912224177000 ext. 4634

drsharmilapatil@yahoo.com

Dr. Gauravi A Mishra, MD contact

+912224177000 ext. 4631

gauravi2005@yahoo.com

About this study

Official title: Compliance, Perceptions and Attitudes of Bus Employees and Commuters Towards Smoke Free Bus Policy (as Part of Smoke Free Public Places) in Mumbai, India

Three years since the Smoke Free Mumbai campaign and six years since the ban on smoking in public places was implemented. It is necessary to review the situation at this point in time so that corrective actions if necessary can be taken. Hence, this study is planned to understand the perceptions and attitudes of commuters and bus employees (drivers, conductors and ticket checkers) regarding the law, its implementation, reactions from the commuters, violations observed, violations reported.

This study will help evaluate the implementation of provision of prohibiting smoking in public places and help understand how to increase the compliance. The results will inform enforcement and public health agencies about where to target enforcement and public education resources.

Read the detailed description

Aim:-1.To assess the knowledge and awareness about tobacco legislation with specific reference to smoke free public places and understand the perceptions and attitude regarding implementation of smoke free BEST policy among BEST employees (mainly drivers, conductors and ticket checkers) in Mumbai. (in terms of reactions from commuters, violations observed, violations reported etc.).

2.Determine the Knowledge, attitudes and perception of BEST commuters about the provisions of smoke free public places and the smoke free public transport.

3.To identify the stakeholder challenges in implementation of the smoke free public transport system in Mumbai 4.To study the compliance with smoke free BEST policy by random observations at the BEST buses, depots and bus stops.

Study Design:

  1. A cross sectional survey design to assess Knowledge, attitudes and perception about Section 4 of COTPA among BEST employees and BEST commuter
  2. Observational design for assessment of compliance to smoke free public transport system (BEST) using a structured compliance tool.

Study Methodology:

  1. Around 500 BEST employees, 500 BEST commuters and 25 management staff responsible for implementation check, in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed by trained Social Workers using a validated structured questionnaire to collect information about their Knowledge and perceptions about provisions with in COTPA 2003 for Smoke free Public Places and perceived challenges with regards to implementation of smoke free public transport with specific reference to smoke free BEST buses.
  2. Observation and reporting regarding compliance to smoke free public places using validated observational study tools will be conducted at 100 randomly selected BEST buses, 100 bus stops and all 26 bus depots.
  3. Observational study tool will consist of the following observations for Compliance to Smoke free BEST Public Transport system.
  4. Presence of no smoking signage: Any pictorial, graphical or textual message displayed in a public place, which warns that smoking is prohibited in a public place, will be recorded as a signage.
  5. Compliance with specifications, as prescribed by COTPA for size, textual content, colour, font and design
  6. Absence of active smoking: At the time of observation.
  7. Absence of cigarettes butts or bidi ends: In Buses, Bus depots and Bus stops.

Definition of Public Places under BEST Bus transport system :

For the purpose of the surveys, the public places under BEST Bus transport system were grouped into three broad categories,

1.BEST Buses 2.BEST Bus Depots, office premises 3. BEST Bus Stops.

Stakeholders to be interviewed to know their views regarding challenges in implementation of the smoke free public transport system in Mumbai

  1. BEST Committee members
  2. Important people in the managerial and administrative cadre in authoritative positions who can influence tobacco policy
  3. Members of Employee Unions within the organization
  4. Medical Unit including - Chief Medical Officers, Junior and Senior Medical Officers, Paramedical workforce
  5. BEST Commuters Forum
  6. Personnel in authoritative positions in: G. M. office
  7. Welfare Department
  8. Personnel Department
  9. PRO Department
  10. Legal Department
  11. BEST Commuters
  12. Any other stakeholders eventually identified

Sampling Methodology:

The list of Bus Depots, Public transport Buses with routes and Bus stops will be prepared with the help of BEST undertaking. Category wise sample of 100 BEST buses, 100 bus stops and all 26 bus depots will be selected through a simple random sampling method .

Times of day for Compliance Survey data collection. There is no best prac¬tice for the time of day for observing compliance. One alternative is to visit venues at peak business hours to assess compliance when the most number of people are affected. Alternatively, venues could be visited at different times of the day.

The present study will collect data at three time sets viz: Morning 9.00- 11.00 am, Afternoon 2.00 -4.00 pm and Evening 5.00-7.00 pm to determine if compliance varies by time of day. The data collection tool will record the time of day of the visit.

Informed consent: Trained Medical Social Workers will administer the informed consent forms to the study participants in the presence of a witness Questionnaire administration Validated pre tested survey questionnaire will be administered to BEST employees and BEST commuters by trained Field investigators to record personal details, self tobacco consumption, knowledge about legislation for Smokefree Public places and perceived challenges in implementing the same.

Observation for Compliance:

Field investigators will be trained to observe violations and to record these on the designed format, for noting the compliance and violations at randomly selected BEST buses, bus stops and bus depots.

Outcome measures Analysis of Observational Data will measure the following outcomes.

  1. The overall rate of compliance for all loca¬tions (Public place) visited.
  2. The compliance rate for each category of location
  3. Overall Compliance on each criteria / parameter selected for recording compliance as per protocol for all locations.
  4. The compliance rate for each criteria / parameter selected for recording compliance for each category of location.

Statistical Analysis Data entry will be done in the Department of Preventive Oncology, Tata Memorial Hospital using SPSS version 18. High quality data collection will be ensured with regular checks for data collection and data entry for completeness and consistency across responses. Descriptive statistics will be used to record compliance, perceptions and attitudes regarding implementation of smoke free BEST policy. Both descriptive and inferential statistics will be generated for describing variables under the study objectives. Interview data will be qualitative in nature and will be analyzed to determine themes from respondents and to identify variations in responses to questions about smoke-free compliance issues. Multivariate analysis will be performed to identify the factors determining compliance to the law .

Benefits:

This project will increase awareness of the BEST employees regarding the law. Results of the study will inform policymakers how well the law is being complied with and the link between the levels of compliance found and resources needed to im¬prove or maintain compliance with smoke-free public places.

Outcomes of the study will help enforcement agencies to take up result oriented measures and also to create greater pressure for action for effective enforcement.

Study will provide information to Managers of the locations visited about overall compli-ance and can be used to design compliance checks that can be conducted at regular intervals and encourage them to comply with the law.

Study results can inform General public/ commuters about lev¬els of compliance with the law, encourage the public to comply with the law, and call for ongoing or increased enforcement of the law by the government.

Proper implementation of the law will help in reducing exposure to second hand smoke, reducing the environmental impact of unsightly litter such as cigarette butts and packets and providing supportive environments for non-smokers and for those attempting to quit smoking. Creating smoke-free outdoor areas, such as public transport stops and stations, can support those who have quit and make smoking less visible to children and young people.

Conditions
Compliance
Keywords
Smoke free bus policy, BEST commuters, BEST employee
Medical subject headings
Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance and Interview

    The overall rate of compliance for all locations (Public place) visited.

    3.

    Measured: 2 years

  2. Compliance and Interview

    The compliance rate for each category of location

    Measured: 2 years

  3. Compliance and Interview

    Overall Compliance on each criteria / parameter selected for recording compliance as per protocol for all locations.

    Measured: 2 years

  4. Compliance and Interview

    The compliance rate for each criteria / parameter selected for recording compliance for each category of location.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionFeb 2017 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,025 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT02363257
Sponsor's protocol ID
1369 BEST-SF
Status last verified
May 2015
First submitted
9 Feb 2015
Last updated
22 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Compliance, run by Tata Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Sharmila A Pimple, MD (+912224177000 ext. 4634, drsharmilapatil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance and Interview (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in