Smoking Cessation in Hospitalized Patients: Efficacy of an Intensive Intervention Program Using an App
Phase: NA
Conditions: Hospitalized Smokers, CBT, Smoking Cessation, Mhealth
Sponsor: University of the Balearic Islands

This document will be signed in duplicate, leaving one copy for the researcher and 
another for the patient.  
INFORMED CONSENT FOR REALIZATION OF RESEARCH PROJECT 
(Version 1, dated 02/10/2019) 
TITLE OF THE STUDY: Smoking cessation in hospitalized patients: Efficacy of an intensive 
intervention program using APP) 
PROMOTER CODE: 
PROMOTER: 
PRINCIPAL INVESTIGATOR: Patricia García Pazo,  
CENTER: Department of Nursing and Physiotherapy, University of the Balearic Islands, telephone 
971259943 
 
I, (name and surname)…………………………………………………………… 
 
 I have read the information sheet given to me. 
 I have been able to ask questions about the study. 
 I have received enough information about the study. 
 I have spoken with: (                                                 ). 
 
 
 
 
 I understand that my participation is voluntary. 
 I understand that I can withdraw from the study as long as I have not been anonymized: 
– 
Whenever you want. 
– 
Without having to explain. 
– 
Without this having an impact on my medical care. 
 I understand that if I decide to withdraw from the study, the results obtained up to that point may 
continue to be used. 
In the event that the results of the investigation provide data that may be of interest to me or my relatives: 
(insert one of the boxes) 
 I want to be informed. 
 I do not want to be informed, but I accept that my doctor contact my relatives if these results 
may affect them. 
 I understand that I have the rights of access, rectification, deletion, opposition, limitation of data 
processing, including transferring my data to an authorized third party (portability), in accordance with 
the provisions of the new Data Protection Regulation (EU) 2016/679 of the European Parliament and of 
the Council, of April 27, 2016, regarding the protection of natural persons regarding the processing of 
personal data and the free movement of these, and in its default, the Organic Law 3/2018, of December 5, 
on the protection of personal data and guarantee of digital rights. 
 
 I freely consent to participate in the study and consent to the access and use of my data under the 
conditions detailed in the patient information sheet. 
Patient's signature:  
Investigator's Signature:  
 
 
 
 
Name:  
Name:  
Date:  
Date:

This document will be signed in duplicate, leaving one copy for the researcher and 
another for the patient.  
PATIENT INFORMATION SHEET FOR THE CONDUCT OF A RESEARCH PROJECT 
(v 2.0 of 03/19/2019) 
TITLE OF THE STUDY: Smoking cessation in hospitalized patients. Efficacy of an intensive 
intervention program APP. 
PROMOTER CODE: 
PROMOTER: 
PRINCIPAL INVESTIGATOR: Patricia García Pazo, professor at the Department of Nursing and 
Physiotherapy, University of the Balearic Islands (UIB), contact telephone number: 971259943. 
 
CENTER: Son Llatzer Hospital 
INTRODUCTION 
We write to you to inform you about a study in which you are invited to participate. The study has been 
approved by the Research Ethics Committee of the Balearic Islands, in accordance with current 
legislation, and is carried out with respect for the principles set forth in the Helsinki declaration and the 
standards of good clinical practice. 
Our intention is only that you receive the correct and sufficient information so that you can evaluate and 
judge whether or not you want to participate in this study. To do this, read this information sheet carefully 
and we will clarify any doubts that may arise after the explanation. In addition, you can consult with the 
people you consider appropriate. If you have any questions, please contact the main researcher, Patricia 
García Pazo. 
GENERAL DESCRIPTION  
Most smokers must stop smoking during the hospital stay, so it is an ideal time to influence the cessation 
of smoking, since otherwise most of them will resume smoking at hospital discharge.  
Therefore, the objective of this study is to provide specialized and intensive treatment for smoking 
cessation during the hospital stay and to improve abstinence rates at one year after hospital discharge. 
This specialized treatment will be carried out by the Smoking Cessation Unit (UDT), a unit that belongs 
to the pulmonology service of the Hospital Son Llatzer and will begin with patients admitted to the 
cardiology, pulmonology and intensive care units. 
This research will compare two treatment branches (A and B) and the patients who wish to participate in 
the study will be selected to one or the other branch according to chance. Treatment A will consist of the 
treatment that is usually given to smokers during their hospital stay and treatment B will be the 
specialized and intensive treatment that the UDT will perform. 
In addition, treatment B will have the support of a self-help Guide incorporated through a mobile 
application (APP). Through this APP you can have help on smoking cessation treatment at any time and 
contact health professionals. 
 These new technologies through a mobile APP have proven to be effective in helping to quit smoking 
thanks to the monitoring and support that the person receives during treatment at any time of the day, 
including during their working hours.  
 
You should also know that participating in this research does not expose you to any additional risk from 
regular treatment. 
In both branches of treatment you will be treated for your nicotine addiction, what changes is the intensity 
and specialization of the help received. 
Treatment B lasts for one month, even if you are discharged from hospital. Then it has a daily follow-up 
through the APP and a telephone follow-up per month, 3 months, 6 months and 12 months. 
In addition, during that month of treatment, the UDT team, through the APP, will inform you of the 
possibility of having an informative meeting, in which you can discuss more specific issues and answer 
your questions.  

This document will be signed in duplicate, leaving one copy for the researcher and 
another for the patient.  
As it is a study, you must commit to carry out all the treatment that we propose, to attend group sessions 
and to attend follow-up visits. As well as communicating whether or not you decide to abandon any 
treatment activity. 
 
The professionals who carry out the intervention will not receive any remuneration. 
 
OTHER RELEVANT INFORMATION  
Pharmacological treatment such as nicotine patches, is a treatment that is licensed and marketed, usually 
administered to hospitalized smokers with high nicotine dependence. It is added to treatments with the 
aim of reducing the discomfort they may feel due to the presence of the symptoms caused by the 
withdrawal syndrome. 
If you wish to participate in this study, you must follow the recommendations of the Guide that we 
provide you through the APP, as well as make correct use of the different options that it will offer you 
until the end of the study.  
If you have any reason why you cannot carry out the treatment, as we indicated, you should notify the 
principal investigator, by email to the mail: niunacaladamas@gmail.com or through the mobile 
application, selecting the help button.  
If you decide to withdraw your consent to participate in this study, we will not add any new data to the 
database from that date of withdrawal, although those responsible for the study may continue to use the 
information collected about you until that time, unless you expressly object. 
You should also know that you can be withdrawn from the study in case the study leaders consider it 
appropriate, either for security reasons, for any adverse event that occurs in the study or because they 
consider that you are not complying with the established procedures. In either case, you will receive an 
adequate explanation of the reason for your withdrawal from the study. 
If you are withdrawn from the study for any of the stated reasons, your doctor will prescribe appropriate 
treatment for your disease. 
By signing the attached consent form, you agree to abide by the study procedures outlined to you.  
BENEFITS AND RISKS ARISING FROM YOUR PARTICIPATION IN THE STUDY 
The expected benefits for you and for society are that you can have all the real information, which is 
provided by health professionals, and you can take advantage of hospital admission to maintain 
abstinence and quit tobacco after hospital discharge. 
This research raises the need for more intensive smoking cessation treatment to help you quit smoking 
during a hospital stay. that today could have cost him admission to the hospital or may even make his 
illness worse, with possible readmissions to the hospital. 
In addition to the fact that tobacco cessation is linked to an improvement in the quality of life, which you 
will notice in your day to day.  
Treatment B of this research is a treatment recommended by the Clinical Practice Guidelines (CPG) based 
on the combination of psychological support, cognitive behavioral type and pharmacological support, if 
necessary. It begins during hospitalization and accompanies you for a year of follow-up. There are no 
added risks to participating in the study. 
You should know that at no time will your name and telephone number (identifying data) be given to 
other users, in addition to the fact that your data made in the mobile application or in the guide will be 
identified with a code that will only associate data and user, the main researcher, compliance with the 
General Data Protection Regulation. 
CONFIDENTIALITY  
Responsible for the file: Patricia García Pazo 
Purpose of the collection: Research project for Doctoral Thesis 

This document will be signed in duplicate, leaving one copy for the researcher and 
another for the patient.  
Legitimation:  
Recipients: There will be no transfer to third parties. 
Rights: access, rectify and delete data 
Additional Information:  
The treatment, communication and transfer of personal data of all participating subjects will comply with 
the provisions of the new Data Protection Regulation (EU) 2016/679 of the European Parliament and of 
the Council, of April 27, 2016, relating to the protection of natural persons regarding the processing of 
personal data and their free movement, and failing that, Organic Law 3/2018, of December 5, on the 
protection of personal data and guarantee of digital rights. In accordance with the provisions of the 
aforementioned legislation, you can exercise the rights of access, rectification, deletion, opposition, 
limitation of data processing, even to transfer your data to an authorized third party (portability), for 
which you must contact the delegate of data protection: Caty Pou. Delegate of Protecció de Dades, 
Universitat de les Illes Balears, Son Lledó, Carretera de Valldemossa, km 7.5, cp. 07121 Palma. 
Telephone: 971259793. E-mail:dpo @ uib.cat 
Your data will be processed electronically and will be incorporated into an automated file of personal data 
whose responsible is the Hospital Son Llatzer, which complies with all security measures with restricted 
access to the objective described in this document. 
To guarantee the confidentiality of the information obtained, Your data will be identified by means of a 
code and only the principal investigator of the study and collaborators will be able to relate these data to 
you and to your medical history. Therefore, your identity will not be revealed to any person except in the 
case of a medical emergency, a requirement from the Health Administration or a legal requirement. 
Only the essential data necessary to carry out the study will be transmitted to third parties and other 
countries, and that in no case will they contain information that can directly identify you, such as name 
and surname, initials, address, Social Security number, etc. In the event that this transfer occurs, it will be 
for the same purposes of the study described and guaranteeing confidentiality at least with the level of 
protection of the legislation in force in our country. 
Access to your personal information will be restricted to the study doctor / collaborators, health 
authorities, the Research Ethics Committee of the Balearic Islands and authorized personnel, when they 
need it to check the study's data and procedures, but always maintaining confidentiality. thereof in 
accordance with current legislation. 
You can file a claim with the Spanish Agency for Data Protection in the event that you consider that your 
data protection rights have been violated. 
Your doctor will not receive any financial compensation for conducting this study and has stated that 
there are no conflicts of interest. 
VOLUNTARY PARTICIPATION 
You should know that your participation in this study is voluntary and that you can decide not to 
participate or change your decision and withdraw your consent at any time, without giving any 
explanation, without thereby altering the relationship with your doctor or the treatment you should 
receive. 
If you decide to revoke your consent, no new data will be collected, but this revocation will not affect the 
investigations carried out so far. 
GRATITUDE 
Whatever your decision, the research team would like to thank you for your time and attention. You are 
contributing to the better knowledge and care of your disease, which in the future may benefit a multitude