Smoking Cessation Clinical Trial
Official title:
Smoking Cessation in Hospitalized Patients: Efficacy of an Intensive Intervention Program Using an App
This study generates a new proposal for intensive intervention following the recommendations
to quit smoking in hospitalized patients, providing intensive, accessible and individualized
treatment, as well as long-term follow-up, thanks to new technologies. The main advantage
that mhealth can bring to public health is cost-effectiveness, scalability and wide reach
compared to traditional treatments. Rapid diffusion and remote outreach can impact
traditional treatment programs, reduce waiting lists for tobacco visits, and increase quit
rates, as well as reduce barriers to accessing smoking cessation programs, by location or
time conflicts. Since the possibility of continuous face-to-face support is very limited,
health interventions carried out through a smartphone can help avoid this situation. The
study by Finkelstein and Me Cha (2016) justifies this line of intervention and solves the
doubt about the feasibility of using the mobile phone to quit smoking in hospitalized
patients, highlighting its usefulness for all patients regadless their age, gender, computer
skills, income and educational level.
-Can an App apply an intensive intervention to stop smoking in the hospitalized patient?
Tobacco use is the leading cause of preventable disease and death in our country. In the
world it is still one of the most serious public health problems due to its morbidity and
mortality. Smoking causes approximately one in ten deaths and it is expected that in 2030
that figure will increase to one in six, which will mean around 7-8 million deaths each year.
Furthermore, quitting smoking is the most effective factor in reducing these deaths. Patients
with heart disease reduce sudden death and its mortality by 36% when they stop smoking.
Likewise, the relative risk of stroke is reduced by 50% when quitting. For all these reasons,
quitting smoking is the most cost-effective treatment compared to other interventions.
The National Health Survey indicates that the reductions in tobacco consumption due to
"natural tendency" are very slow. As an example, if 24% of the population over 15 years of
age smoked daily in 2012, five years later 22% smoked. To control this "epidemic", the World
Health Organization requires several actions: Prevent young people from starting to smoke,
protect non-smokers from air polluted by tobacco smoke and help smokers to quit. smoking
habit.
The Clinical Practice Guidelines (CPG) indicate a variety of treatments that have been shown
to be effective in quitting smoking. The CPG "National Institute for Health and Care
Excellence (NICE) Public Health Guideline" -PH10- (2008), updated in 2013, names the
following treatments in the out-of-hospital setting: offer brief advice (min. 10 minutes);
group or individual behavioral therapies (such as Cognitive-Behavioral Therapy (CBT)), alone
or combined with drugs (at least 4 weeks before the date participants are going to quit);
pharmacotherapy (varenicline, bupropion, or nicotine replacement therapy), alone or in
combination with psychological therapy; self-help material (written or in electronic format);
advice hotline or TV or radio programs.
Smokers are forced to abruptly quit on the day they enter a hospital, given that Law 42/2010
prohibits tobacco consumption not only in the in-hospital physical space, but also in the
external environment. And, although there are unreliable data, it has been estimated that
between 15% and 27% of patients admitted to a hospital in Spain are smokers.
With the goal of helping smokers to quit, hospitalization is a good time to do so, since the
patient is in a smoke-free place and admission can increase the perception of threat to their
health. For this reason, the investigator may find that there is a greater receptiveness to
messages to quit smoking, the so-called "learning moment", and health professionals must take
advantage of this opportunity and make use of the possibilities available to us.
Following these recommendations, the Spanish Society of Pneumology and Thoracic Surgery
(SEPAR) has recently published the regulations on the treatment of smoking in hospitalized
patients, which offer clear guidelines for considering the process of cessation in
hospitalized smokers. In it they indicate the general guidelines of brief intervention during
the care practice towards the smoker known as 5 "As" (Ask, Advise, Assess, Assist, Arrange)
that is (ask, advise, evaluate, help and plan). In addition to highlighting that the
intervention on smoking in hospitalized patients is more effective when done in a
complementary and shared way among the different professionals who care for the subject. At
the same time, a drug treatment of the type Nicotine replacement therapy (NRT) is always
recommended, combined with behavioral therapy with intensive support (greater than or equal
to 4 sessions lasting more than or equal to 15 minutes each) during admission. Highlighting
the importance of continuity of treatment for at least one month after hospital discharge and
with follow-ups at one, three and six months.
In summary, asking patients if they are willing to quit, providing medications that help
along with psychological support, and counseling everyone who says they are willing to quit
smoking has been shown to be effective, especially if there is follow-up at discharge.
Finding statistically significant differences if the follow-up is followed at 6 months and a
year after discharge hospital; as well as the greater the intensity of the advice given.
Despite this evidence and the support of clinical practice guidelines, the level of
application in the hospital is low; interventions that have been shown to be effective in
clinical trials have not been implemented in routine clinical practice in the hospital.
Different ways are proposed to prolong health intervention beyond hospitalization, such as
emails, SMS messages or proactive telephone contact. All these forms increase the
effectiveness of the interventions offered and the effectiveness of these treatments is
related to the duration of the call or the number of messages received, the more contact the
more effective.
New Information and Communication Technologies (TICs) allow smoking cessation therapies to be
applied through applications on mobile devices (Apps), some of which alone have proven to be
effective in addiction therapy.
Aim
-The overall aim of this study is to determine the efficacy of an intensive intervention
based on CBT applied through a App, for smoking cessation during hospitalization compared to
patients receiving conventional clinical practice.
Hypothesis:
-Patients who receive an intensive CBT intervention thanks to the support of a mobile
application "Application" during admission, are more successful in quitting smoking compared
to those who receive conventional treatment.
Design
This is a randomized controlled trial (RCT), a study design that randomly assigns
participants into an Experimental Group (EG) or a Control Group (CG).
two-branch clinical trial in which the group will be randomly assigned using a computer
program, in balanced blocks of 4 patients (2 patients from each group in each block).
The CG will follow routine clinical practice. Currently, at the Public Hospital Son
LLatzer(HSLL) there is no established protocol in the cardiology, pulmonology and Intensive
Care Unit, even so, the CG will at least receive the recommendations of the Clinical Practice
Guidelines which consist of: advice on smoking cessation smoking, leaflet with information
(tobacco components, treatments to reduce withdrawal syndrome) and follow-up after discharge
by the hospital tabacco unit: at one month, at three months, at six months and at one year.
The EG will receive codes to download the App "NoFumo+" that offer a CBT program. Follow-up
after discharge by the hospital tabacco unit: at one month, at six months and at one year.
Participants Study subjects-hospitalized: patients of both sexes smokers, over 18 years,
hospitalized, the investigators define hospitalized as; admission of a patient to the
hospital for a minimum stay of one night. The study will be carried out in the cardiology,
pulmonology and intensive care units of the HSLL.
Sample size determination
Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 116 subjects
is required (to be splitted between the two group conditions) to detect statistical
significant differences between both groups, considering that 20% of the control group will
quit smoking compared to 40% of the intervention group. A follow-up loss rate of 30% has been
estimated.
The assignment of the patient will be carried out by the Main Investigator (MI), once the
patient's consent has been obtained, through a specific program available online. This
program has been designed so that randomization so that the patient's identification data is
entered first and the assigned group is subsequently displayed. Once the patient's
identification data has been entered, it will not be possible to change any data or change
the group to which it has been assigned, and the patient's data and the assigned group will
be recorded.
Study development
The BIT Foundation will develop an App for the study whose main objective will be to have the
treatment available at all times, strengthen adherence and provide follow-up to patients in
the program. The app will have the name "NoFumo+", it can be downloaded through a username
and password only for patients participating in the study. NoFumo+, in addition to having
information about the contents of the guide in digital format, will allow access to the
contents sequentially, once they have passed the previous session. That is, the application
will support and facilitate the patient a continuous monitoring of their treatment for
smoking cessation. NoFumo+ will have:
- Alerts remember to start daily work.
- Daily assessment of changes in craving.
- Participants can consult additional information, through links, to expand information.
- It will inform of the health benefits of staying abstinent. NoFumo+ will calculate from
the day of the discharge (days that it has been abstinent), as well as the monetary
savings and will report the health benefits.
- Participants can consult via email or via chat. The App will have direct mail with the
health-research team or via chat.
- Social support: participants will have a chat to be able to be in contact with other
people who are using the App in the same situation as them, hospitalized or after
discharge with a follow-up of up to one year.
- The participants will receive motivational messages. The App will send the messages in
text format and / or in animated image format of type GIFT, acronym in English for
(Graphics Interchande Format).
The NoFumo+ application will consist of a client app, which resides on the patient's mobile
phone, and a server, which resides on a central computer. NoFumo+ will in no case keep
information about the identity of the patients.
The user App will store a user code, generated randomly, and the password associated with
said user code. The monitoring information of each patient's program will be saved on the
server and will be linked to the patient's user code. The relationship between the user code
and the patient to which it belongs cannot be established by any means based on the data
present in the application. Said relationship will only be in the hands of the main
investigator, registered outside the application (for example, within the patient's medical
history) and in the manner he deems appropriate, following the confidentiality rules
established in these cases.
At the time of the creation of the user account, the patient will be informed in relation to
their rights regarding the treatment and confidentiality of their data. The data will be
processed in accordance with the General Data Protection Regulation of the European
Commission, which is mandatory.
Study variables
Main variables
The dependent variable will be the objective measure of tobacco abstinence from the carbon
monoxide level, abstinent if CO≤6 at 6 and 12 months of follow-up. Carried out using a
co-oximeter (Mini Smokerlyzer, Bedfont instruments, Sittingbourne, Kent, UK).
The independent variable will be membership in the EG or CG group.
Independent secondary variables
- Sociodemographic variables (factors related to the patient): age, sex, marital status,
educational level, employment situation.
- Alcohol consumption (UBE)
- Current pharmacological treatment.
- Smoking history: Age of onset of tobacco use, type of tobacco, use (pack / year),
presence of smokers at home. Previous attempts to quit tobacco: (number of attempts,
method and duration of withdrawal period).
- Clinical diagnosis.
- Reason for admission
- Level of motivation to quit smoking, measured by the "Richmond Motivation Test".
- Nicotine dependence level, measured using the "Fagerstrom Questionnaire".
- Trait anxiety and state anxiety measured by the "State or Trait Anxiety Inventory"
(STAI-E/R).
- Symptoms of depression measured by Beck Depression Inventory II (BDI-I).
- Measure of Anger Trait / State, measured by Anger Inventory (STAXI).
- Identification of disorders related to Alcohol Use measured by the AUDIT questionnaire.
- Short personality questionnaire (TIPY).
- Comorbidities / survival predictor: Charlson index.
- Adherence to the intervention through the use of the App: frequency: number of times
participants connect to the App, duration: the time are connected, completion of the
proposed interactive activities and evaluations carried out.
Statistical analysis
Normality tests and graphs will be used to determine if the variables follow a normal
distribution.
Variables with normal distribution are expressed as mean, standard deviation, and those
without normal distribution are expressed as median and interquartile range.
To evaluate the differences between groups, the student's t test or the Mann-Whitney U test
will be used for the quantitative variables; and the chi-square test or Fisher's exact test
for qualitative variables.
The correlations will be examined by the Spearman or Pearson rank correlation. To evaluate
intra-group differences, paired or related samples tests will be used. A value of p <0.05
will be considered an indicator of a significant difference.
The CART algorithm, acronym for Classification And Regression Trees, will be used to obtain
classification models (binary trees) on the adherence of the subjects to the treatment
program, as well as the success of the program. In this way we can see if there is a smoking
profile that can benefit more from this treatment.
Development of the study: work plan and data collection
The doctor who admits the patient in one of the three units of this study, collects in his
medical history that he is an active smoker and will directly ask him if he is interested in
treating his nicotine addiction during this admission.
-If the patient wants to take advantage of the income to quit smoking . Participants will be
presented with the study and if participants want to participate, participants will initiate
the following steps necessary for this investigation:
Inclusion visit (V0)
- Participants will be informed about the different aspects of the study and participants
will be given the Patient Information Document.
- The informed consent form will be delivered to both groups.
- The PI that will contact him will be informed
1. st Visit (V1)
The MI:
- Participants will be assigned, with a randomized computer program, to one of the
two treatment groups (EG and CG).
- Depending on the EG or CG treatment group, the following intervention will be
carried out:
1. - Intervention in EG: The data collection begins, will carry out CO and a
dossier with questionnaires will be delivered. The Hospital tobacco unit will
start the treatment, a username and password will be provided to download the
App and an explanation of how it works.
2. -Intervencion in CG: The Data Collection Notebook begins, will carry out CO
and will deliver a dossier with questionnaires. Participants will be given
regular treatment without the App.
2. th Visit (V2)
The selected EG patient will receive an App notification every day to work on their
addiction. The treatment will last 30 days in total, divided into 5 phases, each consisting
of three cells, lasting 1 week.
CG patients will follow the usual treatment, including the advice of places or sessions that
they can attend to continue with the help of either Basic Health Units or the hospital
tobacco service in the case of HSLL.
Follow-up visits (V3)
- The EG will be summoned by phone at the Hospital Tobacco service to carry out CO and
assess treatment (follow-up interview).
- The CG will carry out a telephone intervention; if they remain abstinent, it will be
cited by the hopital tobacco service for CO.
Follow-up visits will be carried out in both groups the first month after completing the
daily treatment of the App, six months and one year after withdrawal.
Ethical Considerations
Before the start of the study, the project will be presented to the Ethical and Research
Committee of the Balearic Islands (CEI). In the case of HSLL, to the Research Commission of
the hospital. Health professionals participating in the study will sign a confidentiality
document. Before starting any study procedure, the informed consent of each patient must be
obtained. The recommendations contained in the Declaration of Helsinki and the Organic Law
15/1999 on Data Protection will be followed.
This study will fully adhere to the standards of good clinical practice that any clinical
study must follow. All participating researchers will receive training to standardize
criteria and they will insist on the dissemination and understanding of the aforementioned
standards. The consent will be kept with the documents of the researcher's study.
During the trial, the investigators must immediately notify the CEI of any Serious Adverse
Event allegedly related to the intervention within the time limits established by current
regulations. Likewise, the CEI must be notified of deviations from the protocol; new
information that may affect the safety of the subjects or the performance of the test and the
information of the test follow-up as required by the CEI. For any reason to withdraw from the
study, affected patients should continue with the most appropriate treatment, in the judgment
of the healthcare staff attending them. If the eligible subject requires a reflection time to
confirm participation in the study, they will be granted a period of 24 hours during which
they will receive the usual treatment.
Limitations
The investigators found a limitation at the end of the study, due to the difficulty of
applying the treatment to all patients admitted to the hospital, the possibility of
face-to-face monitoring and co-oximetry due to lack of resources / personnel.
On the other hand, patients admitted to the Intensive Care Unit could be a special group due
to the critical episode experienced during admission. Having the critically ill patient
undergo intensive treatment at that time, while still in the Intensive CareUnit, could lead
to a greater predisposition to quit smoking. The investigators want to reduce this bias by
randomizing the patients into different groups, thus there would have a similar number in
both groups. Furthermore, the investigators could assess the motivating value of the
traumatic experience and its influence on adherence and temporal generalization.
Due to this intervention, it could improve the usual care by the responsible physician, when
asked about the participation of the study.
Scientific relevance and applicability
This study aims to provide more data to the scientific community on the importance of
performing a combined and intensive treatment to help quit smoking in smoking patients,
taking advantage of their hospital admission.
With the help of TICs, in this case the App, the investigators try to improve its
applicability to be able to proactively carry out intense treatment (frequency and time spent
on smoking cessation)
If this program were to prove effective, it could be applied to all patients hospitalized in
other hospital services to be treated for nicotine dependence and the App will be available
to all patients free of charge.
;
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