<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502004</url>
  </required_header>
  <id_info>
    <org_study_id>IB 3835/19 PI</org_study_id>
    <nct_id>NCT04502004</nct_id>
  </id_info>
  <brief_title>Smoking Cessation in Hospitalized Patients Using an App</brief_title>
  <acronym>NoFumo+</acronym>
  <official_title>Smoking Cessation in Hospitalized Patients: Efficacy of an Intensive Intervention Program Using an App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Balearic Islands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Son Llatzer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of the Balearic Islands</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study generates a new proposal for intensive intervention following the recommendations&#xD;
      to quit smoking in hospitalized patients, providing intensive, accessible and individualized&#xD;
      treatment, as well as long-term follow-up, thanks to new technologies. The main advantage&#xD;
      that mhealth can bring to public health is cost-effectiveness, scalability and wide reach&#xD;
      compared to traditional treatments. Rapid diffusion and remote outreach can impact&#xD;
      traditional treatment programs, reduce waiting lists for tobacco visits, and increase quit&#xD;
      rates, as well as reduce barriers to accessing smoking cessation programs, by location or&#xD;
      time conflicts. Since the possibility of continuous face-to-face support is very limited,&#xD;
      health interventions carried out through a smartphone can help avoid this situation. The&#xD;
      study by Finkelstein and Me Cha (2016) justifies this line of intervention and solves the&#xD;
      doubt about the feasibility of using the mobile phone to quit smoking in hospitalized&#xD;
      patients, highlighting its usefulness for all patients regadless their age, gender, computer&#xD;
      skills, income and educational level.&#xD;
&#xD;
      -Can an App apply an intensive intervention to stop smoking in the hospitalized patient?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tobacco use is the leading cause of preventable disease and death in our country. In the&#xD;
      world it is still one of the most serious public health problems due to its morbidity and&#xD;
      mortality. Smoking causes approximately one in ten deaths and it is expected that in 2030&#xD;
      that figure will increase to one in six, which will mean around 7-8 million deaths each year.&#xD;
&#xD;
      Furthermore, quitting smoking is the most effective factor in reducing these deaths. Patients&#xD;
      with heart disease reduce sudden death and its mortality by 36% when they stop smoking.&#xD;
      Likewise, the relative risk of stroke is reduced by 50% when quitting. For all these reasons,&#xD;
      quitting smoking is the most cost-effective treatment compared to other interventions.&#xD;
&#xD;
      The National Health Survey indicates that the reductions in tobacco consumption due to&#xD;
      &quot;natural tendency&quot; are very slow. As an example, if 24% of the population over 15 years of&#xD;
      age smoked daily in 2012, five years later 22% smoked. To control this &quot;epidemic&quot;, the World&#xD;
      Health Organization requires several actions: Prevent young people from starting to smoke,&#xD;
      protect non-smokers from air polluted by tobacco smoke and help smokers to quit. smoking&#xD;
      habit.&#xD;
&#xD;
      The Clinical Practice Guidelines (CPG) indicate a variety of treatments that have been shown&#xD;
      to be effective in quitting smoking. The CPG &quot;National Institute for Health and Care&#xD;
      Excellence (NICE) Public Health Guideline&quot; -PH10- (2008), updated in 2013, names the&#xD;
      following treatments in the out-of-hospital setting: offer brief advice (min. 10 minutes);&#xD;
      group or individual behavioral therapies (such as Cognitive-Behavioral Therapy (CBT)), alone&#xD;
      or combined with drugs (at least 4 weeks before the date participants are going to quit);&#xD;
      pharmacotherapy (varenicline, bupropion, or nicotine replacement therapy), alone or in&#xD;
      combination with psychological therapy; self-help material (written or in electronic format);&#xD;
      advice hotline or TV or radio programs.&#xD;
&#xD;
      Smokers are forced to abruptly quit on the day they enter a hospital, given that Law 42/2010&#xD;
      prohibits tobacco consumption not only in the in-hospital physical space, but also in the&#xD;
      external environment. And, although there are unreliable data, it has been estimated that&#xD;
      between 15% and 27% of patients admitted to a hospital in Spain are smokers.&#xD;
&#xD;
      With the goal of helping smokers to quit, hospitalization is a good time to do so, since the&#xD;
      patient is in a smoke-free place and admission can increase the perception of threat to their&#xD;
      health. For this reason, the investigator may find that there is a greater receptiveness to&#xD;
      messages to quit smoking, the so-called &quot;learning moment&quot;, and health professionals must take&#xD;
      advantage of this opportunity and make use of the possibilities available to us.&#xD;
&#xD;
      Following these recommendations, the Spanish Society of Pneumology and Thoracic Surgery&#xD;
      (SEPAR) has recently published the regulations on the treatment of smoking in hospitalized&#xD;
      patients, which offer clear guidelines for considering the process of cessation in&#xD;
      hospitalized smokers. In it they indicate the general guidelines of brief intervention during&#xD;
      the care practice towards the smoker known as 5 &quot;As&quot; (Ask, Advise, Assess, Assist, Arrange)&#xD;
      that is (ask, advise, evaluate, help and plan). In addition to highlighting that the&#xD;
      intervention on smoking in hospitalized patients is more effective when done in a&#xD;
      complementary and shared way among the different professionals who care for the subject. At&#xD;
      the same time, a drug treatment of the type Nicotine replacement therapy (NRT) is always&#xD;
      recommended, combined with behavioral therapy with intensive support (greater than or equal&#xD;
      to 4 sessions lasting more than or equal to 15 minutes each) during admission. Highlighting&#xD;
      the importance of continuity of treatment for at least one month after hospital discharge and&#xD;
      with follow-ups at one, three and six months.&#xD;
&#xD;
      In summary, asking patients if they are willing to quit, providing medications that help&#xD;
      along with psychological support, and counseling everyone who says they are willing to quit&#xD;
      smoking has been shown to be effective, especially if there is follow-up at discharge.&#xD;
      Finding statistically significant differences if the follow-up is followed at 6 months and a&#xD;
      year after discharge hospital; as well as the greater the intensity of the advice given.&#xD;
&#xD;
      Despite this evidence and the support of clinical practice guidelines, the level of&#xD;
      application in the hospital is low; interventions that have been shown to be effective in&#xD;
      clinical trials have not been implemented in routine clinical practice in the hospital.&#xD;
&#xD;
      Different ways are proposed to prolong health intervention beyond hospitalization, such as&#xD;
      emails, SMS messages or proactive telephone contact. All these forms increase the&#xD;
      effectiveness of the interventions offered and the effectiveness of these treatments is&#xD;
      related to the duration of the call or the number of messages received, the more contact the&#xD;
      more effective.&#xD;
&#xD;
      New Information and Communication Technologies (TICs) allow smoking cessation therapies to be&#xD;
      applied through applications on mobile devices (Apps), some of which alone have proven to be&#xD;
      effective in addiction therapy.&#xD;
&#xD;
      Aim&#xD;
&#xD;
      -The overall aim of this study is to determine the efficacy of an intensive intervention&#xD;
      based on CBT applied through a App, for smoking cessation during hospitalization compared to&#xD;
      patients receiving conventional clinical practice.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      -Patients who receive an intensive CBT intervention thanks to the support of a mobile&#xD;
      application &quot;Application&quot; during admission, are more successful in quitting smoking compared&#xD;
      to those who receive conventional treatment.&#xD;
&#xD;
      Design&#xD;
&#xD;
      This is a randomized controlled trial (RCT), a study design that randomly assigns&#xD;
      participants into an Experimental Group (EG) or a Control Group (CG).&#xD;
&#xD;
      two-branch clinical trial in which the group will be randomly assigned using a computer&#xD;
      program, in balanced blocks of 4 patients (2 patients from each group in each block).&#xD;
&#xD;
      The CG will follow routine clinical practice. Currently, at the Public Hospital Son&#xD;
      LLatzer(HSLL) there is no established protocol in the cardiology, pulmonology and Intensive&#xD;
      Care Unit, even so, the CG will at least receive the recommendations of the Clinical Practice&#xD;
      Guidelines which consist of: advice on smoking cessation smoking, leaflet with information&#xD;
      (tobacco components, treatments to reduce withdrawal syndrome) and follow-up after discharge&#xD;
      by the hospital tabacco unit: at one month, at three months, at six months and at one year.&#xD;
&#xD;
      The EG will receive codes to download the App &quot;NoFumo+&quot; that offer a CBT program. Follow-up&#xD;
      after discharge by the hospital tabacco unit: at one month, at six months and at one year.&#xD;
&#xD;
      Participants Study subjects-hospitalized: patients of both sexes smokers, over 18 years,&#xD;
      hospitalized, the investigators define hospitalized as; admission of a patient to the&#xD;
      hospital for a minimum stay of one night. The study will be carried out in the cardiology,&#xD;
      pulmonology and intensive care units of the HSLL.&#xD;
&#xD;
      Sample size determination&#xD;
&#xD;
      Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 116 subjects&#xD;
      is required (to be splitted between the two group conditions) to detect statistical&#xD;
      significant differences between both groups, considering that 20% of the control group will&#xD;
      quit smoking compared to 40% of the intervention group. A follow-up loss rate of 30% has been&#xD;
      estimated.&#xD;
&#xD;
      The assignment of the patient will be carried out by the Main Investigator (MI), once the&#xD;
      patient's consent has been obtained, through a specific program available online. This&#xD;
      program has been designed so that randomization so that the patient's identification data is&#xD;
      entered first and the assigned group is subsequently displayed. Once the patient's&#xD;
      identification data has been entered, it will not be possible to change any data or change&#xD;
      the group to which it has been assigned, and the patient's data and the assigned group will&#xD;
      be recorded.&#xD;
&#xD;
      Study development&#xD;
&#xD;
      The BIT Foundation will develop an App for the study whose main objective will be to have the&#xD;
      treatment available at all times, strengthen adherence and provide follow-up to patients in&#xD;
      the program. The app will have the name &quot;NoFumo+&quot;, it can be downloaded through a username&#xD;
      and password only for patients participating in the study. NoFumo+, in addition to having&#xD;
      information about the contents of the guide in digital format, will allow access to the&#xD;
      contents sequentially, once they have passed the previous session. That is, the application&#xD;
      will support and facilitate the patient a continuous monitoring of their treatment for&#xD;
      smoking cessation. NoFumo+ will have:&#xD;
&#xD;
        -  Alerts remember to start daily work.&#xD;
&#xD;
        -  Daily assessment of changes in craving.&#xD;
&#xD;
        -  Participants can consult additional information, through links, to expand information.&#xD;
&#xD;
        -  It will inform of the health benefits of staying abstinent. NoFumo+ will calculate from&#xD;
           the day of the discharge (days that it has been abstinent), as well as the monetary&#xD;
           savings and will report the health benefits.&#xD;
&#xD;
        -  Participants can consult via email or via chat. The App will have direct mail with the&#xD;
           health-research team or via chat.&#xD;
&#xD;
        -  Social support: participants will have a chat to be able to be in contact with other&#xD;
           people who are using the App in the same situation as them, hospitalized or after&#xD;
           discharge with a follow-up of up to one year.&#xD;
&#xD;
        -  The participants will receive motivational messages. The App will send the messages in&#xD;
           text format and / or in animated image format of type GIFT, acronym in English for&#xD;
           (Graphics Interchande Format).&#xD;
&#xD;
      The NoFumo+ application will consist of a client app, which resides on the patient's mobile&#xD;
      phone, and a server, which resides on a central computer. NoFumo+ will in no case keep&#xD;
      information about the identity of the patients.&#xD;
&#xD;
      The user App will store a user code, generated randomly, and the password associated with&#xD;
      said user code. The monitoring information of each patient's program will be saved on the&#xD;
      server and will be linked to the patient's user code. The relationship between the user code&#xD;
      and the patient to which it belongs cannot be established by any means based on the data&#xD;
      present in the application. Said relationship will only be in the hands of the main&#xD;
      investigator, registered outside the application (for example, within the patient's medical&#xD;
      history) and in the manner he deems appropriate, following the confidentiality rules&#xD;
      established in these cases.&#xD;
&#xD;
      At the time of the creation of the user account, the patient will be informed in relation to&#xD;
      their rights regarding the treatment and confidentiality of their data. The data will be&#xD;
      processed in accordance with the General Data Protection Regulation of the European&#xD;
      Commission, which is mandatory.&#xD;
&#xD;
      Study variables&#xD;
&#xD;
      Main variables&#xD;
&#xD;
      The dependent variable will be the objective measure of tobacco abstinence from the carbon&#xD;
      monoxide level, abstinent if CO≤6 at 6 and 12 months of follow-up. Carried out using a&#xD;
      co-oximeter (Mini Smokerlyzer, Bedfont instruments, Sittingbourne, Kent, UK).&#xD;
&#xD;
      The independent variable will be membership in the EG or CG group.&#xD;
&#xD;
      Independent secondary variables&#xD;
&#xD;
        -  Sociodemographic variables (factors related to the patient): age, sex, marital status,&#xD;
           educational level, employment situation.&#xD;
&#xD;
        -  Alcohol consumption (UBE)&#xD;
&#xD;
        -  Current pharmacological treatment.&#xD;
&#xD;
        -  Smoking history: Age of onset of tobacco use, type of tobacco, use (pack / year),&#xD;
           presence of smokers at home. Previous attempts to quit tobacco: (number of attempts,&#xD;
           method and duration of withdrawal period).&#xD;
&#xD;
        -  Clinical diagnosis.&#xD;
&#xD;
        -  Reason for admission&#xD;
&#xD;
        -  Level of motivation to quit smoking, measured by the &quot;Richmond Motivation Test&quot;.&#xD;
&#xD;
        -  Nicotine dependence level, measured using the &quot;Fagerstrom Questionnaire&quot;.&#xD;
&#xD;
        -  Trait anxiety and state anxiety measured by the &quot;State or Trait Anxiety Inventory&quot;&#xD;
           (STAI-E/R).&#xD;
&#xD;
        -  Symptoms of depression measured by Beck Depression Inventory II (BDI-I).&#xD;
&#xD;
        -  Measure of Anger Trait / State, measured by Anger Inventory (STAXI).&#xD;
&#xD;
        -  Identification of disorders related to Alcohol Use measured by the AUDIT questionnaire.&#xD;
&#xD;
        -  Short personality questionnaire (TIPY).&#xD;
&#xD;
        -  Comorbidities / survival predictor: Charlson index.&#xD;
&#xD;
        -  Adherence to the intervention through the use of the App: frequency: number of times&#xD;
           participants connect to the App, duration: the time are connected, completion of the&#xD;
           proposed interactive activities and evaluations carried out.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      Normality tests and graphs will be used to determine if the variables follow a normal&#xD;
      distribution.&#xD;
&#xD;
      Variables with normal distribution are expressed as mean, standard deviation, and those&#xD;
      without normal distribution are expressed as median and interquartile range.&#xD;
&#xD;
      To evaluate the differences between groups, the student's t test or the Mann-Whitney U test&#xD;
      will be used for the quantitative variables; and the chi-square test or Fisher's exact test&#xD;
      for qualitative variables.&#xD;
&#xD;
      The correlations will be examined by the Spearman or Pearson rank correlation. To evaluate&#xD;
      intra-group differences, paired or related samples tests will be used. A value of p &lt;0.05&#xD;
      will be considered an indicator of a significant difference.&#xD;
&#xD;
      The CART algorithm, acronym for Classification And Regression Trees, will be used to obtain&#xD;
      classification models (binary trees) on the adherence of the subjects to the treatment&#xD;
      program, as well as the success of the program. In this way we can see if there is a smoking&#xD;
      profile that can benefit more from this treatment.&#xD;
&#xD;
      Development of the study: work plan and data collection&#xD;
&#xD;
      The doctor who admits the patient in one of the three units of this study, collects in his&#xD;
      medical history that he is an active smoker and will directly ask him if he is interested in&#xD;
      treating his nicotine addiction during this admission.&#xD;
&#xD;
      -If the patient wants to take advantage of the income to quit smoking . Participants will be&#xD;
      presented with the study and if participants want to participate, participants will initiate&#xD;
      the following steps necessary for this investigation:&#xD;
&#xD;
      Inclusion visit (V0)&#xD;
&#xD;
      - Participants will be informed about the different aspects of the study and participants&#xD;
      will be given the Patient Information Document.&#xD;
&#xD;
      - The informed consent form will be delivered to both groups.&#xD;
&#xD;
      - The PI that will contact him will be informed&#xD;
&#xD;
        1. st Visit (V1)&#xD;
&#xD;
           The MI:&#xD;
&#xD;
             -  Participants will be assigned, with a randomized computer program, to one of the&#xD;
                two treatment groups (EG and CG).&#xD;
&#xD;
             -  Depending on the EG or CG treatment group, the following intervention will be&#xD;
                carried out:&#xD;
&#xD;
                  1. - Intervention in EG: The data collection begins, will carry out CO and a&#xD;
                     dossier with questionnaires will be delivered. The Hospital tobacco unit will&#xD;
                     start the treatment, a username and password will be provided to download the&#xD;
                     App and an explanation of how it works.&#xD;
&#xD;
                  2. -Intervencion in CG: The Data Collection Notebook begins, will carry out CO&#xD;
                     and will deliver a dossier with questionnaires. Participants will be given&#xD;
                     regular treatment without the App.&#xD;
&#xD;
        2. th Visit (V2)&#xD;
&#xD;
      The selected EG patient will receive an App notification every day to work on their&#xD;
      addiction. The treatment will last 30 days in total, divided into 5 phases, each consisting&#xD;
      of three cells, lasting 1 week.&#xD;
&#xD;
      CG patients will follow the usual treatment, including the advice of places or sessions that&#xD;
      they can attend to continue with the help of either Basic Health Units or the hospital&#xD;
      tobacco service in the case of HSLL.&#xD;
&#xD;
      Follow-up visits (V3)&#xD;
&#xD;
        -  The EG will be summoned by phone at the Hospital Tobacco service to carry out CO and&#xD;
           assess treatment (follow-up interview).&#xD;
&#xD;
        -  The CG will carry out a telephone intervention; if they remain abstinent, it will be&#xD;
           cited by the hopital tobacco service for CO.&#xD;
&#xD;
      Follow-up visits will be carried out in both groups the first month after completing the&#xD;
      daily treatment of the App, six months and one year after withdrawal.&#xD;
&#xD;
      Ethical Considerations&#xD;
&#xD;
      Before the start of the study, the project will be presented to the Ethical and Research&#xD;
      Committee of the Balearic Islands (CEI). In the case of HSLL, to the Research Commission of&#xD;
      the hospital. Health professionals participating in the study will sign a confidentiality&#xD;
      document. Before starting any study procedure, the informed consent of each patient must be&#xD;
      obtained. The recommendations contained in the Declaration of Helsinki and the Organic Law&#xD;
      15/1999 on Data Protection will be followed.&#xD;
&#xD;
      This study will fully adhere to the standards of good clinical practice that any clinical&#xD;
      study must follow. All participating researchers will receive training to standardize&#xD;
      criteria and they will insist on the dissemination and understanding of the aforementioned&#xD;
      standards. The consent will be kept with the documents of the researcher's study.&#xD;
&#xD;
      During the trial, the investigators must immediately notify the CEI of any Serious Adverse&#xD;
      Event allegedly related to the intervention within the time limits established by current&#xD;
      regulations. Likewise, the CEI must be notified of deviations from the protocol; new&#xD;
      information that may affect the safety of the subjects or the performance of the test and the&#xD;
      information of the test follow-up as required by the CEI. For any reason to withdraw from the&#xD;
      study, affected patients should continue with the most appropriate treatment, in the judgment&#xD;
      of the healthcare staff attending them. If the eligible subject requires a reflection time to&#xD;
      confirm participation in the study, they will be granted a period of 24 hours during which&#xD;
      they will receive the usual treatment.&#xD;
&#xD;
      Limitations&#xD;
&#xD;
      The investigators found a limitation at the end of the study, due to the difficulty of&#xD;
      applying the treatment to all patients admitted to the hospital, the possibility of&#xD;
      face-to-face monitoring and co-oximetry due to lack of resources / personnel.&#xD;
&#xD;
      On the other hand, patients admitted to the Intensive Care Unit could be a special group due&#xD;
      to the critical episode experienced during admission. Having the critically ill patient&#xD;
      undergo intensive treatment at that time, while still in the Intensive CareUnit, could lead&#xD;
      to a greater predisposition to quit smoking. The investigators want to reduce this bias by&#xD;
      randomizing the patients into different groups, thus there would have a similar number in&#xD;
      both groups. Furthermore, the investigators could assess the motivating value of the&#xD;
      traumatic experience and its influence on adherence and temporal generalization.&#xD;
&#xD;
      Due to this intervention, it could improve the usual care by the responsible physician, when&#xD;
      asked about the participation of the study.&#xD;
&#xD;
      Scientific relevance and applicability&#xD;
&#xD;
      This study aims to provide more data to the scientific community on the importance of&#xD;
      performing a combined and intensive treatment to help quit smoking in smoking patients,&#xD;
      taking advantage of their hospital admission.&#xD;
&#xD;
      With the help of TICs, in this case the App, the investigators try to improve its&#xD;
      applicability to be able to proactively carry out intense treatment (frequency and time spent&#xD;
      on smoking cessation)&#xD;
&#xD;
      If this program were to prove effective, it could be applied to all patients hospitalized in&#xD;
      other hospital services to be treated for nicotine dependence and the App will be available&#xD;
      to all patients free of charge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 14, 2019</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>To assess differences between groups, use the student t-test or the Mann-Whitney U-test for quantitative variables; and the chi-square test or Fisher's exact test for qualitative variables.&#xD;
Correlations are examined by the Spearman or Pearson rank correlation. Paired or related sample tests will be used to assess intra-group differences. A value of p &lt;0.05 will be considered an indicator of a significant difference.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effectiveness of the App intervention</measure>
    <time_frame>1 year</time_frame>
    <description>32 participants will have a objective measure of tobacco abstinence from the carbon monoxide level, abstinent if CO≤6 at 6 and 12 months of follow-up</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Hospitalized Smokers</condition>
  <condition>CBT</condition>
  <condition>Smoking Cessation</condition>
  <condition>Mhealth</condition>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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).&#xD;
Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group (EG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive codes to download the App &quot;NoFumo+&quot; . Is a mHealth that offer a CBT program. Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>App for health=mhealth</intervention_name>
    <description>Cognitive-Behavioural Therapy and Clinical Practice Guide that recommends 5 Aes: Ask about tobacco, Advise smoking cessation, Assess tobacco consumption, Assist and Arrange (Fiore et alt., 2008)</description>
    <arm_group_label>Experimental Group (EG)</arm_group_label>
    <other_name>(NoFumo+)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient candidates to participate must meet each and every one of the following&#xD;
             inclusion criteria:&#xD;
&#xD;
          -  Patients over 18 years of both sexes, who sign the informed consent to participate in&#xD;
             the study.&#xD;
&#xD;
          -  Patients who register wanting to quit smoking during admission&#xD;
&#xD;
          -  Active smoking patients at the time of hospital admission or ex-smokers with less than&#xD;
             6 months of evolution.&#xD;
&#xD;
          -  Autonomous patients with the capacity to understand the treatment.&#xD;
&#xD;
          -  Patients who have an Android and Iphone Smartphone, accustomed to their use sith&#xD;
             superior operating system 5.0 or 4.0 respectively.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet any of the following exclusion criteria:&#xD;
&#xD;
          -  Serious medical illness that prevents the patient from participating in the tobacco&#xD;
             cessation intervention study.&#xD;
&#xD;
          -  Ex-smoking patients of more than 6 months of evolution.&#xD;
&#xD;
          -  Active patients in substance abuse.&#xD;
&#xD;
          -  Patients with any current condition (medical, psychological or social) that limits the&#xD;
             patient's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de las Islas Baleares</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Baleares</state>
        <zip>07122</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia García-Pazo, Profesora</last_name>
      <phone>609683256</phone>
      <email>patricia.garcia@uib.es</email>
    </contact>
    <contact_backup>
      <last_name>Psicología</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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    <citation>West R, Raw M, McNeill A, Stead L, Aveyard P, Bitton J, Stapleton J, McRobbie H, Pokhrel S, Lester-George A, Borland R. Health-care interventions to promote and assist tobacco cessation: a review of efficacy, effectiveness and affordability for use in national guideline development. Addiction. 2015 Sep;110(9):1388-403. doi: 10.1111/add.12998.</citation>
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  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04502004/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502004
org study id: IB 3835/19 PI
nct id: NCT04502004
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: To assess differences between groups, use the student t-test or the Mann-Whitney U-test for quantitative variables; and the chi-square test or Fisher's exact test for qualitative variables.
Correlations are examined by the Spearman or Pearson rank correlation. Paired or related sample tests will be used to assess intra-group differences. A value of p <0.05 will be considered an indicator of a significant difference.
primary purpose: Treatment
masking: None (Open Label)
measure: effectiveness of the App intervention
time frame: 1 year
description: 32 participants will have a objective measure of tobacco abstinence from the carbon monoxide level, abstinent if CO≤6 at 6 and 12 months of follow-up
arm group label: Control Group (CG)
arm group type: No Intervention
description: 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).
Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.
arm group label: Experimental Group (EG)
arm group type: Experimental
description: Receive codes to download the App "NoFumo+" . Is a mHealth that offer a CBT program. Follow-up after discharge by the hospital tabacco service: at one month, at three months, at six months and at one year.
intervention type: Device
intervention name: App for health=mhealth
description: Cognitive-Behavioural Therapy and Clinical Practice Guide that recommends 5 Aes: Ask about tobacco, Advise smoking cessation, Assess tobacco consumption, Assist and Arrange (Fiore et alt., 2008)
arm group label: Experimental Group (EG)
other name: (NoFumo+)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
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