Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04782453 |
| Other study ID # |
AN_2018_36 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
September 18, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Sangath |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Tobacco use is associated with high mortality, and a range of morbidities including cancer,
and lung and cardiovascular diseases. Furthermore, tobacco users who die prematurely deprive
their families of income, raise the cost of health care and hinder economic development.
India is the second-largest consumer (current use-48% males, 20% females; 275 million adults)
and third largest producer of tobacco in the world5; and has one of the highest mortality
related to tobacco. The treatment gap for tobacco use in India is as high as 92%.
Opportunistic screening and brief interventions in primary care, although recommended by the
World Health Organization (WHO), is largely missing in current practice in India.
The existing tobacco cessation strategy in India has shown limited success due to poor
availability and accessibility of tobacco cessation services, and non-availability of
interventions that are culturally relevant and contextual to the target population.
Preliminary formative research as a part of the larger ToQuit study has informed the
development of the first version of the treatment package. This first version of the package
was tested through a case series, by refining the intervention content and delivery
mechanisms through an iterative process, to develop the final intervention. This pilot
Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility and
acceptability of the mobile-based brief intervention (BI) for tobacco use, generate
preliminary estimates of the impact of the BI, and fine-tune the procedures for a definitive
RCT.
Description:
ToQuit study aims to overcome the accessibility and feasibility hurdles by developing and
evaluating a tobacco-cessation intervention that can be delivered using low cost and easily
available mobile text messaging. India has 1.2 billion mobile phone subscriptions
(tele-density 92%) and this provides a unique opportunity to significantly increase the
penetration and coverage of tobacco cessation interventions in a low health-resource setting.
This pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility
and acceptability of the mobile-based brief intervention (BI) for tobacco use, generate
preliminary estimates of the impact of the BI, and fine-tune the procedures for a definitive
RCT.
This protocol will serve as a research framework for the implementation of the proposed pilot
RCT.
Objectives:
1. To test and refine procedures for a definitive RCT.
2. To assess the feasibility and acceptability of delivering the mobile-based BI for
tobacco use.
3. To refine the mobile-based BI package for a definitive RCT.
4. To assess the impact of the mobile-based BI on tobacco use.
5. To inform sample size calculations for the definitive RCT.
Study setting:
The study recruitment will be conducted online and hence participants will include any
eligible individual residing in India.
Sample size:
We will include a sample of 100 participants, 50 each in the intervention and control groups.
This sample size estimates are based on our previous experiences of pilot RCTs and deemed
sufficient to achieve the goals of understanding the acceptability, feasibility, and
preliminary impact of an intervention. The sample size of 80 enrolled tobacco users randomly
allocated with a 1:1 allocation ratio, with 5% type I error and 6% abstinence in the control
arm at follow up would provide 80% statistical power to detect an effect of 5.3 (relative
risk) for abstinence in favour of ToQuit intervention.11 Considering a 20% loss rate during
the follow-up period as per our experience in case series, the total sample of 100
participants would be needed.
Recruitment sources:
• The recruitment advertisements will be shared over the social media accounts of Sangath
India (an organization where all the research staff is based) and contacts of the
researchers. We will also display advertisement posters in the public health facilities and
dental clinics in Goa state and at public places such as village panchayats, supermarkets
etc. The individuals willing to quit tobacco will be asked to send 'ToQuit' message on the
designated mobile number.
- Gatekeepers such as Anganwadi (community-based integrated child development services
delivery centres in India) workers , local panchayat leaders, Accredited social health
activist (ASHA) workers: The researchers will build awareness about the project in the
community and seek assistance from community gatekeepers. Gatekeepers would:
1. Refer patients to the researchers.
2. Inform people in the community about ToQuit, and ask them to contact ToQuit
researchers
- Medical officer (MO) at primary health centres (PHC)/dentists at district hospital (DH)
and private dental clinics: The PHC MO and dentists at DH and private clinics will be
informed about the study and will be requested to refer patients who are using tobacco
to the researchers for screening. Project team will leave calling cards with them to
handout to the patients.
Screening:
When a 'ToQuit' message is received from a potential participant, one of the researchers will
call on the mobile number and inform them about the study. If the respondent is willing to
participate, researcher will proceed with initial screening for eligibility.
Tobacco users who do not fulfil the eligibility criteria will be thanked for their time, and
will be suggested to seek help from a general practitioner, primary health centre, or a
tobacco cessation clinic (TCC) in their area.
Consenting:
Potential participants who fulfill all the eligibility criteria will be given information
about their participation in the study. Each potential participant will also be taken through
the informed consent process and will be requested to provide written consent to participate
in the study. The study researcher will ensure that any questions/queries the participant may
have about the intervention are resolved before the participant provides their consent. All
consent procedures will be audio-recorded with the permission of the participant.
When done remotely, if accessible to the potential participant, a researcher will send the
information sheet and consent form via email/WhatsApp messaging app. If the potential
participant does not have access to these, then the researcher will read out the information
sheet before the screening.
Respondents who do not consent to participate in the study will be requested to give minimal
sociodemographic data (age, gender, educational status, employment status, marital status),
to examine whether there is a systematic difference between those who consent and those who
do not. Reason for refusal will be recorded. They will be thanked for their time and will be
suggested to seek help from a general practitioner, primary health centre, or a TCC in their
area.
Baseline assessments:
Baseline measures administered to consenting participants will include:
1. Sociodemographic data:
Data about potential confounders such as age, gender, employment status, educational
status, and marital status will be collected through a socio-demographic form.
2. Tobacco use:
Type of tobacco used to understand if there are any differences in outcomes in smokers and
smokeless tobacco users.
2. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): Participants will
then be administered the 6 questions about tobacco use from the ASSIST tool. The ASSIST is
the screening test which covers all psychoactive substances including alcohol, tobacco and
illicit drugs, and can help identify individuals who may have hazardous, harmful or dependent
use of one or more substance.12 ASSIST has shown good concurrent, construct, predictive and
discriminative validity to be used in India. It has good reliability and feasibility in
culturally diverse settings and with different substance use patterns.13 3. Information
required for delivery of intervention The participant will be asked the questions related to
intervention delivery such as preferred days and time, and preferred language to send the
intervention messages. The researcher will inform the participant about tentative schedule of
receiving messages and end the call.
Sampling:
The participants will be stratified in two groups, smokeless tobacco users and smokers.
Consenting eligible participants in both these strata will be randomly allocated to
intervention or control group, in 1:1 ratio. An independent data manager will generate a
randomisation list and participants will be randomised using Sequentially Numbered Opaque
Sealed Envelopes to maximise allocation concealment. Consenting eligible participants'
contact numbers will be added to the intervention database.
Intervention:
Participants from the ToQuit intervention arm will receive the messages on their mobile phone
for 8 weeks. The intervention messages will consist of specific content areas derived from
the formative research of the study. Some of the components of the intervention include:
Psychoeducation about consequences of tobacco use and benefits of quitting; goal setting;
managing goals and self-monitoring of behaviour; avoidance strategies; self-awareness and
reflection messages; social and pharmacological support, help-seeking; identifying and
managing cravings; and relapse prevention strategies. The messages will be sent for 3-4 days
a week.
Participants from the control group will be sent the details of other functional tobacco
helplines in India.
Nested qualitative study:
Qualitative outcome interviews will be conducted with a sub-sample of participants from the
intervention group to gain insight into the impact of the mobile-based BI on the tobacco use.
We will purposively select those who report abstinence and those who do not report
abstinence. An interview guide will be developed focused on understanding the acceptability,
feasibility, and perceived impact of the intervention.
Data analysis:
- Quantitative- Quantitative outcome data will be analysed using STATA 16, consistent with
CONSORT guidelines for parallel randomized controlled trials. The process indicators will be
presented using a trial flow chart.14 Baseline characteristics of participants with respect
to consented and not consented, outcome assessments completed and not completed, and
differences between intervention and the control arms, will be presented as proportions or
means as appropriate. For primary analysis, complete case analysis will be conducted,
adjusted for baseline variables with imbalance, if any. Secondary analysis will be
intention-to-treat at the 3 month end-point regardless of treatment adherence. Regression
analysis will be conducted for the treatment outcomes. Effect size will be reported as odds
ratio with 95% confidence interval for the primary outcome, between intervention and control
group. Standardized mean differences with 95% confidence intervals will be calculated for
ASSIST scores of the two arms, and changes in scores from baseline and follow up.
Missing outcome data will be imputed using mean imputation or multiple imputation.
Sensitivity analysis will be conducted assuming data missing at random, and outcome groups
will be compared by replacing missing values with 'abstinence achieved' as 'best case
scenario' and by failure to achieve the abstinence as 'worst case scenario'.
- Qualitative- Thematic analysis will be used to analyse the qualitative data from the
outcome interviews, using N-vivo version 12.15 Analysis will involve generation of codes from
raw data. Themes will be derived by retrieving pieces of data pertaining to codes and by
examining their meaning in relation to the research questions (acceptability of the content
and delivery of the mobile-based intervention, barriers to engagement, impact on tobacco
use).
