Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02103868 |
| Other study ID # |
TMHPOZariW2013 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
April 1, 2014 |
| Last updated |
February 4, 2015 |
| Start date |
October 2013 |
| Est. completion date |
January 2016 |
Study information
| Verified date |
February 2015 |
| Source |
Tata Memorial Hospital |
| Contact |
Sharmila A Pimple, Professor |
| Phone |
+912224154379 |
| Email |
drsharmilapatil[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
India: Data Monitoring Committee |
| Study type |
Interventional
|
Clinical Trial Summary
Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be
divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation
intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control
arm. At the end of 12 months of intervention quit rates will be compared.
Description:
Aims and Objectives
Broad objective:
The proposed study is planned to understand prevalence and practices related to tobacco use
among workers of the informal sector of Zari Industry and to assess the feasibility and
acceptability of effective strategies of a programmatic approach towards tobacco use
prevention and cessation intervention model in this by assessment of pre and
post-intervention knowledge, attitude and perception of tobacco use, followed by offering
education and cessation and finally assessing the impact and outcomes by changes in the
attitudes towards tobacco use and quit rates among tobacco users.
Specific objectives:
Primary Objectives:
1. To assess knowledge and understand the practices related to tobacco use among the Zari
workers' population using qualitative research.
2. To implement a multicomponent community-based intervention model through trained health
workers in an unorganized workplace setting.
3. To assess any change in the Knowledge Attitude and Practices related to tobacco use at
post intervention.
4. Determine tobacco cessation rates at the end of intervention.
Secondary Objectives:
1. To provide oral screening service to the target groups at the end of the interventions.
2. Develop a LOCAL -language tobacco use prevention and cessation training module to train
counsellors in tobacco cessation interventions.
Study Methodology
Design:
A prospective, community-based randomized controlled design
Settings: Community based Zari work units of three urban slum pockets in Mumbai
Sampling:
Three distinct urban slum communities in Mumbai where Zari units operate will be identified.
Each of the slum community will serve as three arms of the trial, with one geographic
cluster / community serving as the intervention community for moderate intensity
intervention, second cluster /community for low intensity intervention and the third
cluster/community serving as the control arm with no intervention. These communities will be
recruited on the basis of comparable socio-demographic characteristics.
Tools of Data Collection:
Questionnaire:
A pre designed structured baseline questionnaire will be prepared to understand the
determinants that trigger the onset of tobacco use, dynamics of regular use of tobacco and
factors that motivate the user to quit tobacco. Written informed consent will be taken from
all the participants.
The questionnaire at baseline will be administered in local language before the
implementation of the intervention and will be repeated after 1 year with the same sample at
end to assess the efficacy of the intervention. The questionnaire will be administered by a
trained interviewer as per the convenience of the respondents.
Intervention Arm:
Intervention A community-based multi-component intervention model developed, will be
implemented and evaluated in the intervention community. The intervention model will address
numerous socio-environmental and intra-personal factors that trigger the onset of tobacco
use and other determinants that influence tobacco cessation.
The intervention consists of :
1. Awareness & Education on Tobacco use prevention:
Interactive activities, pre-tested posters, in addition, pictorial handouts, booklets
and pamphlets will be distributed for knowledge enhancement by trained social workers.
The first interaction with the workers will involve an elaborate common education
programme on harms of tobacco use, tobacco use prevention and benefits of tobacco
cessation, by an audio visual presentation and distribution of pamphlets for knowledge
enhancement by trained social workers. All participants will be assessed for their
tobacco use status prior to the intervention. The participants with history of current
tobacco use in any form will then be enrolled for further interventions for tobacco
cessation. A structured questionnaire detailing information on sociodemographic
variables with medical and other risk factors with complete assessment of their tobacco
habit will be entered by medical social workers. All participants will be assessed for
their tobacco use status at all interventions.
2. Focus Group discussion:
This tobacco cessation intervention session with the tobacco users after three months
of the first contact program will involve thirty minutes of focus group discussion with
group behavioral therapy in groups of 5-10 individuals for reinforcement of tobacco use
prevention and cessation advice. Group discussion is intended to improve understanding
by exploring, sharing and reflecting psychosocial, familial, environmental issues which
attribute to the problem. Members of the group are encouraged to exchange information
and ideas about the perceived barriers towards tobacco cessation. Techniques like
reflecting, exploring and re-evaluation will be used to identify their problem to
improve insight and reinforce attitudinal change.
3. Individual tobacco cessation counseling sessions:
Iindividual counseling is commonly used to help people who are trying to quit tobacco. The
counseling adopting a interactive problem-solving approach will be done by trained Medical
Social Workers providing face-to-face sessions for 10-15 minutes per participant,
Types of Intervention
1. Medium Intensity Intervention
The Medium intensity arm will implement the multi-component program with three contact
programs.
I. First Contact program: Group health education session II. Second Contact program:
Focus Group Discussion III. Third Contact program: Brief Individual Counseling session
2. Low Intensity Intervention
Single contact session with Group health education session will be provided to the
participants
Final Outcome Final outcome measure, the quit rates as self reported tobacco abstinence will
be assessed at the end of one year.
Oral cancer screening:
All the Zari workers will also be invited for oral cancer screening at the end of
intervention program.
Oral cancer screening to detect clinically recognizable precancerous lesions (leukoplakia,
erythroplakia and oral submucous fibrosis) and asymptomatic early invasive lesions will be
done by trained Primary Health Workers. Visual examination of the oral cavity with good
light source like halogen flashlight, is a simple approach to detect asymptomatic oral
cancers and precancerous lesions. The performance characteristics of this test are
satisfactory in terms of sensitivity, specificity, and predictive value therefore, it is a
suitable screening test for oral cancer. One large study from Kerala has shown that
screening by visual inspection of the mouth by trained health workers may potentially reduce
mortality in high risk groups.
The clinical findings will be recorded as 1. Normal; 2. Benign or non cancerous lesions such
as fissures in the tongue, aphthous ulcer, black patch, tobacco-related blanching, fibroma,
hypertrophied papillae, etc.; and 3. Pre cancer lesions if found to have a white patch,
ulcerated white patch, verrucous lesion, submucous fibrosis, red patch, suspicious ulcer or
growth. All the above findings suspicious for oral precancer on screening evaluation will be
referred for further diagnostic evaluation by medical officers.
Control Arm:
No Active Intervention will be given in the control arm, but will distributed tobacco
awareness pamphlets in local languages. Only base line and end line survey assessment will
be done.
Training as tobacco cessation counselors & Development of Module.
1. Recruitment and training of staff This involves the recruitment of project personnel
and their training. Training would involve the theoretical and practical teaching of
questionnaire/survey as well modular training for tobacco cessation counseling to the
project personnel.
2. Preparation of resource materials and questionnaire formats Resource materials would
include training module for tobacco use prevention and tobacco cessation techniques
with Individual and Group therapy sessions with pamphlets outlining the harmful effects
of tobacco.
Outcome measures
The two outcome measures used from the survey questionnaire were 'ever use' and 'current
use' of tobacco at baseline and endline. 'Ever users' were those who had consumed tobacco in
any form in their life time. 'Current users' were those who had consumed tobacco in any form
in the past one week. Current use at baseline and endline were compared to calculate the
'quit rate' and 'rate of fresh uptake'. Quit rate of tobacco use among the communities will
be estimated as the proportion of workers who become non-users at endline from among those
who were current users in the baseline survey. Rate of fresh uptake will be estimated as the
proportion of workers who reported themselves as ever users or current users at endline from
among those who were never users at the baseline survey.
Data Management and Analysis
Data will be entered and analyzed using SPSS version 18.3 The trial data will be analyzed on
an intention to treat basis and the participants will be included in the final analysis
irrespective of whether or not they could be followed up in all subsequent visits. Self
reported history will be taken as the main criteria to assess outcome of tobacco cessation.
Multivariate analysis will be performed to identify the factors promoting the use of tobacco
and quitting tobacco. The tobacco quit rates will be calculated as percentages. The post
intervention changes in the KAP of employees will be compared to the pre-intervention KAP.
Groups will be compared using non-parametric statistical techniques.
