Smoking Cessation Clinical Trial
Official title:
WhatsApp Embedded in Routine Service Delivery for Smoking Cessation: Effects on Success Rates in a Randomized Controlled Study
Background: Recently, the use of communication technologies and social media applications has
become increasingly widespread to strengthen efforts for smoking cessation. The purpose of
this study is; to assess the effect on success rate of the WhatsApp application which is
embedded in the smoking cessation policlinic service delivery.
Materials and Methods: A randomized controlled intervention study was conducted with 132
volunteers who were followed up at the EUTF Smoking Cessation Policlinic between March-July
2017. The intervention content based on transtheoretic model was prepared and 60 WhatsApp
messages were delivered to participants for 3 months of follow up. For data collection,
initial interview form and follow up form consisting sociodemographic characteristics,
smoking status, medical condition and treatment, were used. The success rate at first and
third months were assessed by the point-prevalence regarding the previous week.
Intention-to-treat analysis was used. For secondary outcomes; number of follow-ups, change in
weight and continuity of medication were evaluated.
Findings: Success rate in the first month was 65.9% for intervention group and 40.9% in the
control group; for the third month it was 50.0% in the intervention group and 30.7% in the
control group. Being in the intervention group increased the success rate by 3,50 (1,30-9,44)
times in the first month and 2,50 (1,08-6,40) times in the third month. The intervention was
the only parameter effective in the two follow-up periods; the difference in success rate
caused by gender, marital status and work-related social class has been eliminated after
adjustment for the intervention.
Trial design
The study was designed as a RCT including two parallel arms: an intervention group receiving
messages through WhatsApp Messenger operating on smart phones and a control group not
receiving these messages. Both groups received the standard outpatient care of the clinic
including aproximately 45 minutes face-to-face individual counseling at first contact ending
with the decision of treatment and quit date, and a support booklet on quitting and
subsequent follow-ups by the same clinician at 1st, 2nd, 4th weeks and 3rd month after quit
date, either face-to-face at the clinic or by telephone if the patient does not come to the
clinic for follow-up. The study was carried out in the smoking cessation clinic of Ege
University Medical School's Public Health Department.
Sample size
An a priori power analysis was conducted with OpenEpi, Version 3 by selecting a two-sided
test to compare 30% success in the control group at 1st month versus 60% success rate in the
intervention group with an error margin of 5%, a power of 80% and an allocation ratio of 1:2
which yielded a minimum sample size of 36 in the intervention and 72 in the control groups.
For possible loss to follow-up, the sample sizes were increased by 20% to 43 and 86,
respectively.
Randomization
Among the 132 participants included in the study, 44 were randomly allocated to the
intervention arm and 88 were randomly allocated to the control group. Among the intervention
group , there were no losses to follow-up at 1st and 3rd months, but two participants have
requested the cessation of the intervention after their 1st month follow-up.
Blinding
The study was single-blind as blinding of the helthcare providers to intervention assignment
was achieved and the physicians conducted usual care for smoking cessation counseling.The
physicians were blind throughout the follow ups as well. However, participants and the
researcher who sent the messages were not blind.
Variables
Primary outcome variables: Quitting success rates at the end of the 1st, 3rd and 6th month of
follow-up in the intervention and control groups. Quitting success rate at 1st month was
calculated with point prevalence. History of cessation was based on self report and those who
declared not smoked even a single puff on a cigarette at all in the past two weeks were
considered as "successful" in the quitting attempt. The success rate at 3rd month was
calculated with point prevalence. In this point, not smoking at all in total in the past ten
weeks was considered "successful" in the quitting attempt. The success rate at 6th month was
calculated with point prevalence. In this point, not smoking at all in total in the past 24
weeks was considered "successful" in the quitting attempt.
Secondary outcome variables: The total number of follow-ups in the 1st, 3rd and 6th month.
Contacts were divided into two categories: face-to face contacts and telephone calls. The
total number of routine follow-ups was classified as adequate when 3 or more in the 1st month
and a total of 4 follow-ups was considered as adequate at 3rd month. At 1st month, at least
one of these follow-ups was required to be face-to-face for adequacy. The continuity to
drug/NRT therapy was categorized as <1 month or ≥1 month. Any change in weight was
categorized as; has weight gain, no weight gain
Data collection Data collection was conducted at the Smoking Cessation Clinic of the Public
Health Department at Ege University Medical School Hospital between March 2017-March 2018.
The intended number of participants was achieved in 4.5 months and with the completion of the
last follow-up, the study was finalized.
Analysis
The analyses were conducted according to the Intention-To-Treat (ITT) principle. The
participants lost to follow-up were considered unsuccessful in quitting, as non-response
could be expected in relapsing individuals, thus Last Observation Carried Forward (LOCF) was
not used.
Smoking cessation successes in the groups were compared with the incidences and relative
efficacy of the intervention. Chi-square test, Student's t test in independent groups, single
and multivariate logistic regression (enter method) were used for analyses. The multivariate
analysis of factors associated with smoking cessation success was performed by using logistic
regression analysis with two models. In the first model the investigators controlled for age
and gender, in the second model controlling was for age, gender and all the other associated
variables in univariate analyses. Analyses were made separately for the 1st, 3rd and 6th
month. Statistical significance was set at p<0.05.
Ethical issues
The study was approved by Ege University Medical School's institutional review board
(decision no.16-12.1/11 on January 6, 2017). Written informed consent of every participant to
enroll and receive WhatsApp messages were also obtained with confidentiality for name and
address. With the blinding procedures described above, the delivery of routine service for
all participants regardless of the allocation to intervention or control group was ensured.
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