xml: <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/NCT05997901</url>
    </required_header>
    <id_info>
      <org_study_id>PJT-180405</org_study_id>
      <nct_id>NCT05997901</nct_id>
    </id_info>
    <brief_title>Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study</brief_title>
    <official_title>Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre for Addiction and Mental Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Canadian Cancer Society (CCS)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre for Addiction and Mental Health</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this feasibility study is to co-create and evaluate a theory informed,&#xD;
        evidence-based, patient-centered healthbot aimed at helping people adhere to their&#xD;
        varenicline regimen. The main research questions it aims to answer are:&#xD;
  &#xD;
          1. What are the challenges to varenicline adherence and strategies to overcome such&#xD;
             challenges from the perspective of service users and service providers?&#xD;
  &#xD;
          2. What features of a healthbot would help improve adherence to varenicline?&#xD;
  &#xD;
          3. Does a healthbot developed to improve varenicline adherence meet the implementation&#xD;
             outcomes and increase medication adherence as well as smoking cessation? The study will&#xD;
             be conducted using the Discover Design Build and Test framework.&#xD;
  &#xD;
               -  In the Discover phase, a literature review, 20 service user interviews, and 20&#xD;
                  healthcare provider interviews will help inform the challenges to varenicline&#xD;
                  adherence, strategies to overcome them using the Capability, Opportunity,&#xD;
                  Motivation, and Behavior framework, and the ways in which a healthbot might help&#xD;
                  improve adherence.&#xD;
  &#xD;
               -  In the Design, Build and Test phase, 40 participants will interact with a&#xD;
                  preliminary healthbot using the Wizard of Oz method, then provide feedback about&#xD;
                  their experiences in a follow up interview; and team members, including clinicians&#xD;
                  and researchers, will beta test and validate a more refined healthbot.&#xD;
  &#xD;
        In the last phase, a non-randomized single arm feasibility study, 40 participants will&#xD;
        interact with the healthbot for 12 weeks and provide feedback about the acceptability,&#xD;
        appropriateness, fidelity, adoption, and usability of the healthbot; and researchers will&#xD;
        assess participants' medication adherence and smoking status.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A: Co-design a theory informed healthbot to support patients' adherence to varenicline:&#xD;
  &#xD;
        The investigators will employ a user-centred approach to build the healthbot in order to&#xD;
        optimize user experience and achieve the best uptake and utilization. Following the Discover,&#xD;
        Design and Build, and Test (DDBT) framework, the investigators will use a three-step approach&#xD;
        to co-design the core functionality of the healthbot: 1) review the literature and conduct&#xD;
        interviews with potential users (Discovery Phase); 2) design the healthbot and conduct Wizard&#xD;
        of Oz testing (Design/Build Phase); 3) Train and test the healthbot (Test Phase).&#xD;
  &#xD;
        Literature review:&#xD;
  &#xD;
        The aim of this rapid review is two folded: 1) to identify the barriers and facilitators to&#xD;
        varenicline adherence, in people using varenicline for smoking cessation (the investigators&#xD;
        will use the Theoretical Domains Framework (TDF) to organize the data extraction), and 2) to&#xD;
        identify the behaviour change techniques (BCTs) that are associated with helping people&#xD;
        adhere to their varenicline treatment (the investigators will use BCTT v1. to organize the&#xD;
        data extraction). The study was registered with PROSPERO (# CRD42022321838).&#xD;
  &#xD;
        Semi-Structured Interviews with people who use varenicline:&#xD;
  &#xD;
        To gain in-depth understanding of the challenges and solutions people who use varenicline&#xD;
        encounter and to understand what features users would like to see in a healthbot designed to&#xD;
        help adhere to varenicline.&#xD;
  &#xD;
        Semi-Structured Interviews with health care providers who help people who want to quit&#xD;
        smoking:&#xD;
  &#xD;
        There is little guidance regarding health care providers' (HCP) perspectives in recommending&#xD;
        digital health solutions to their patients. Understanding the perspectives of HCPs is crucial&#xD;
        to facilitate the effective delivery and uptake of the healthbot. These interviews will&#xD;
        explore: (1) barriers/facilitators influencing HCPs provision of digital health solutions to&#xD;
        patients prescribed varenicline; (2) Identify theoretical domains to target for behaviour&#xD;
        change; (3) Select BCTs to include in the healthbot.&#xD;
  &#xD;
        Wizard of Oz Method:&#xD;
  &#xD;
        The purpose of this stage is to test a minimum viable product to determine whether the&#xD;
        product needs a pivot. Pivots are structured improvements designed to test new fundamental&#xD;
        hypotheses about products, strategies, and growth engines and often occur in the early stages&#xD;
        of product development. The Wizard of Oz (WoZ) method is a popular approach wherein research&#xD;
        participants interact with a computer system they believe is autonomous; however, responses&#xD;
        are actually generated by an unseen human being (the wizard). It is useful in iterative&#xD;
        development as it is very easy to change and evolve the wizard's responses.&#xD;
  &#xD;
        Building the healthbot (Build Phase):&#xD;
  &#xD;
        Following guidance from the Nonadoption, abandonment, scale-up, spread, and sustainability&#xD;
        (NASSS) framework, the investigators will build the healthbot choosing the simplest sensible&#xD;
        solution for the design. For this study, the investigators will build a rule-based healthbot,&#xD;
        that has capabilities to determine the meaning of users' words. The rules will come from the&#xD;
        literature review, the interviews, and WoZ testing. Specifically, following the discovery&#xD;
        phase, the research team will rate all BCTs identified as possible contributors to helping&#xD;
        people adhere to their varenicline based on whether it is affordable, practical, effective,&#xD;
        acceptable, safe and equitable (APEASE criteria).&#xD;
  &#xD;
        Training and testing (Test Phase):&#xD;
  &#xD;
        The interviews and WoZ data will serve to help train the healthbot. In addition, once the&#xD;
        investigators have a working prototype of the healthbot, team members including clinicians&#xD;
        and researchers will interact with the healthbot to beta test and validate it.&#xD;
  &#xD;
        B: Evaluate the implementation outcomes; examine medication adherence and smoking cessation&#xD;
        success among participants who use the healthbot:&#xD;
  &#xD;
        The investigators will conduct a non-randomized single arm feasibility study. It will only&#xD;
        have an intervention group (with no control group) and is designed to examine important study&#xD;
        procedures (e.g., patient recruitment, retention, missing data), in advance of a larger&#xD;
        randomized controlled trial (RCT) testing the effectiveness of the healthbot.&#xD;
  &#xD;
        Interested individuals will contact research staff, who will explain the study and assess for&#xD;
        inclusion criteria. If eligible, participants will be sent a consent form and scheduled for a&#xD;
        phone-based consent discussion. Once consent is received, an in person or virtual baseline&#xD;
        visit will be scheduled where participants (n=40) will complete an online questionnaire,&#xD;
        including questions related to socio-demographic characteristics, smoking dependency, and an&#xD;
        adapted scale to measure varenicline adherence self-efficacy. They will have a virtual on in&#xD;
        person visit a healthcare provider for eligibility confirmation and obtain a prescription for&#xD;
        varenicline the first four weeks (one tablet [0.5 mg] daily for the first three days, one&#xD;
        tablet [0.5 mg] twice daily for the next four days, and one tablet [1 mg] twice daily for&#xD;
        three weeks). In addition, research staff will show participants how to use the healthbot on&#xD;
        their phones. A follow up visit will be scheduled at two weeks where healthcare providers&#xD;
        will assess the participant's tolerance of varenicline and provide a prescription for the&#xD;
        remaining eight weeks (one tablet (1 mg) twice daily or a different dose depending on the&#xD;
        tolerance of each participant). Medication will be provided in person or mailed to the&#xD;
        participants based on the format of their baseline and follow up healthcare provider visit.&#xD;
        Any unanticipated problems due to varenicline use (i.e., adverse events that are unexpected&#xD;
        in terms of severity, nature or frequency; related, or possibly related to participation in&#xD;
        the research; and suggest that the research places other research participants at greater&#xD;
        risk of harm) will be documented as applicable and reported to the Research Ethics Board and&#xD;
        adverse drug reactions will be reported to the Market Authorization Holder (APOTEX) as&#xD;
        applicable.&#xD;
  &#xD;
        The healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information&#xD;
        and suggestions on managing known side effects (the most frequently cited reason for&#xD;
        varenicline non-adherence is experiencing side effects); 3) answers to questions about&#xD;
        medication use (e.g., what to do if a dose is missed); 4) tracking medication intake and&#xD;
        smoking; 5) support and encouragement to increase participants' motivation to continue their&#xD;
        quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to&#xD;
        take their varenicline at the appropriate times and will be able to interact with the&#xD;
        healthbot when they want.&#xD;
  &#xD;
        At 1, 4, 8, and 12 weeks, participants will complete a survey. At the beginning of the study,&#xD;
        participants will be able to choose if they answer the questions through the healthbot or&#xD;
        online. All participants who do not complete the online/healthbot follow-up within the&#xD;
        timeframe allowed will be contacted by phone from research staff. In addition, after the 12&#xD;
        weeks of using the healthbot, participants will participate in a 1-hour semi-structured phone&#xD;
        interview.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 12, 2022</start_date>
    <completion_date type="Anticipated">December 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 12, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The investigators will conduct a non-randomized single arm feasibility study. It will only have an intervention group, and is designed to examine important study procedures (e.g., patient recruitment, retention, missing data), in advance of a larger randomized controlled trial (RCT) testing the effectiveness of the healthbot.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>12 weeks</time_frame>
      <description>The extent to which an innovation is agreeable, palatable, or satisfactory to a stakeholder. In order to measure acceptability, the investigators will utilize the four-item Acceptability of Intervention Measure (AIM) in the follow up surveys and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The acceptability will also be assessed through open ended questions in the semi-structured interviews.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Appropriateness</measure>
      <time_frame>12 weeks</time_frame>
      <description>The perceived fit or compatibility of an innovation with a practice setting or context. For this study, appropriateness will be measured at the individual level (e.g., alignment with users' attitudes, needs, and background) in the 12 week survey, with the Intervention Appropriateness Measure (IAM), a validated 4-item intervention appropriateness scale, and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The appropriateness will also be assessed in-depth in the semi-structured interviews.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fidelity</measure>
      <time_frame>12 weeks</time_frame>
      <description>The extent to which an intervention is used as intended. For this study, the investigators will explore in the semi-structured interviews what functions of the healthbot participants used, what they used the healthbot for (e.g., answer questions, receive support), frequency of use, and quality, i.e., whether the healthbot delivered the correct information according to the user.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoption</measure>
      <time_frame>12 weeks</time_frame>
      <description>The intention, decision, or initiation of use for an evidence-based practice, characterizing it at the level of the provider or organization. Given that the concept of adoption aligns with constructs of actual system use, researchers examining behavioural intervention technologies (such as the healthbot) have expanded this level of analysis to that of the consumer. In this study, the investigators will measure the adoption of the healthbot by examining analytics data, which the healthbot will passively collect in in-app logs, during the 12 weeks that the participant is scheduled to take the varenicline.&#xD;
  The investigators will measure adoption through multiple healthbot analytics, including when (day/time) the user interacted with the healthbot, which features were used, and time spent engaged. If the mean use is ≤20 time, it will be considered as the cutoff point to not progress to a randomized controlled trial.&#xD;
  We will also explore participants' perceived use of the hea</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability</measure>
      <time_frame>12 weeks</time_frame>
      <description>Will be assessed using the System Usability Scale (SUS). The SUS is a 10-item measure assessing usability and user satisfaction with technology. A score of ≤40 will be considered as the cutoff point to not progress to a randomized controlled trial.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Medication Adherence</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will be asked about their medication adherence using timeline follow-back (TLFB) in the surveys collected at 1, 4, 8, and 12 weeks. Participants will report the number of pills taken since the previous assessment. Participants will be asked to send pictures of the blister packs via email at 1, 4, 8, and 12 weeks. These two methods will be used to assess the feasibility of measuring adherence through these different methods, to help understand which method would be most appropriate for any follow up RCT. Participants who used the healthbot to log their medications will be able to import this data to the survey. We selected TLFB to measure adherence since the 12 week TLFB measure is moderately correlated with saliva varenicline levels, and is considered the best practical measure of varenicline adherence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Smoking Status</measure>
      <time_frame>12 weeks</time_frame>
      <description>Smoking abstinence will be assessed during the follow up surveys at 1, 4, 8 and 12 weeks, and will be defined by a negative response to the dichotomous 7-day point prevalence question, &quot;Have you had a cigarette, even a puff, in the last seven days?&quot;</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Medication Adherence</condition>
    <condition>Smoking Cessation</condition>
    <arm_group>
      <arm_group_label>Varenicline healthbot</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>While the exact healthbot features will be based on results from the rapid review, interviews and Wizard of OZ testing, the investigators know from the existing literature on medication adherence, and behaviour change interventions, that the healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information and suggestions on managing known side effects (the most frequently cited reason for varenicline non-adherence is experiencing side effects); 3) answers to questions about medication use (e.g., what to do if a dose is missed); and 4) support to increase participants' motivation to continue their quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to take their varenicline at the appropriate times, and will be able to interact with the healthbot when they want.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Varenicline healthbot</intervention_name>
      <description>The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.</description>
      <arm_group_label>Varenicline healthbot</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Treatment-seeking smokers who are willing to start taking varenicline and continue it&#xD;
               for 12 weeks, and set a quit date in the next 30 days;&#xD;
  &#xD;
            -  Smoke cigarettes daily (10 or more cigarettes a day)&#xD;
  &#xD;
            -  Age ≥ 18 years;&#xD;
  &#xD;
            -  Speak/read English;&#xD;
  &#xD;
            -  Have a smartphone with data plan;&#xD;
  &#xD;
            -  Report being committed to answering questions during follow-up;&#xD;
  &#xD;
            -  Live in Ontario.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have contraindication(s) to varenicline use;&#xD;
  &#xD;
            -  Are pregnant/planning to become pregnant/breastfeeding;&#xD;
  &#xD;
            -  Participated in the co-design phase.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nadia Minian, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CAMH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nadia Minian, PhD</last_name>
      <phone>4165358501</phone>
      <phone_ext>77420</phone_ext>
      <email>Nadia.Minian2@camh.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre for Addiction and Mental Health</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M6J1H4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nadia Minian, PhD</last_name>
        <phone>4165358501</phone>
        <phone_ext>77420</phone_ext>
        <email>Nadia.Minian2@camh.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
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      <citation>Booke J. SUS-A quick and dirty usability scale. In Jordan P, Thomas B, (Eds). Usability Evaluation In Industry: Taylor and Francis 1996.</citation>
    </reference>
    <reference>
      <citation>Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict. 1989 Jul;84(7):791-9. doi: 10.1111/j.1360-0443.1989.tb03059.x.</citation>
      <PMID>2758152</PMID>
    </reference>
    <reference>
      <citation>Brown RA, Burgess ES, Sales SD, et al. Reliability and validity of a smoking timeline follow-back interview. Psychology of Addictive Behaviors. 1998;12(2):101-112.</citation>
    </reference>
    <reference>
      <citation>Peng AR, Morales M, Wileyto EP, Hawk LW Jr, Cinciripini P, George TP, Benowitz NL, Nollen NL, Lerman C, Tyndale RF, Schnoll R. Measures and predictors of varenicline adherence in the treatment of nicotine dependence. Addict Behav. 2017 Dec;75:122-129. doi: 10.1016/j.addbeh.2017.07.006. Epub 2017 Jul 12.</citation>
      <PMID>28728040</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 14, 2022</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
      <investigator_full_name>Nadia Minian</investigator_full_name>
      <investigator_title>Scientist</investigator_title>
    </responsible_party>
    <keyword>Medication Adherence</keyword>
    <keyword>Smoking Cessation</keyword>
    <keyword>Varenicline</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varenicline</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997901
  org study id: PJT-180405
  nct id: NCT05997901
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this feasibility study is to co-create and evaluate a theory informed,
        evidence-based, patient-centered healthbot aimed at helping people adhere to their
        varenicline regimen. The main research questions it aims to answer are:
  
          1. What are the challenges to varenicline adherence and strategies to overcome such
             challenges from the perspective of service users and service providers?
  
          2. What features of a healthbot would help improve adherence to varenicline?
  
          3. Does a healthbot developed to improve varenicline adherence meet the implementation
             outcomes and increase medication adherence as well as smoking cessation? The study will
             be conducted using the Discover Design Build and Test framework.
  
               -  In the Discover phase, a literature review, 20 service user interviews, and 20
                  healthcare provider interviews will help inform the challenges to varenicline
                  adherence, strategies to overcome them using the Capability, Opportunity,
                  Motivation, and Behavior framework, and the ways in which a healthbot might help
                  improve adherence.
  
               -  In the Design, Build and Test phase, 40 participants will interact with a
                  preliminary healthbot using the Wizard of Oz method, then provide feedback about
                  their experiences in a follow up interview; and team members, including clinicians
                  and researchers, will beta test and validate a more refined healthbot.
  
        In the last phase, a non-randomized single arm feasibility study, 40 participants will
        interact with the healthbot for 12 weeks and provide feedback about the acceptability,
        appropriateness, fidelity, adoption, and usability of the healthbot; and researchers will
        assess participants' medication adherence and smoking status.
  A: Co-design a theory informed healthbot to support patients' adherence to varenicline:
  
        The investigators will employ a user-centred approach to build the healthbot in order to
        optimize user experience and achieve the best uptake and utilization. Following the Discover,
        Design and Build, and Test (DDBT) framework, the investigators will use a three-step approach
        to co-design the core functionality of the healthbot: 1) review the literature and conduct
        interviews with potential users (Discovery Phase); 2) design the healthbot and conduct Wizard
        of Oz testing (Design/Build Phase); 3) Train and test the healthbot (Test Phase).
  
        Literature review:
  
        The aim of this rapid review is two folded: 1) to identify the barriers and facilitators to
        varenicline adherence, in people using varenicline for smoking cessation (the investigators
        will use the Theoretical Domains Framework (TDF) to organize the data extraction), and 2) to
        identify the behaviour change techniques (BCTs) that are associated with helping people
        adhere to their varenicline treatment (the investigators will use BCTT v1. to organize the
        data extraction). The study was registered with PROSPERO (# CRD42022321838).
  
        Semi-Structured Interviews with people who use varenicline:
  
        To gain in-depth understanding of the challenges and solutions people who use varenicline
        encounter and to understand what features users would like to see in a healthbot designed to
        help adhere to varenicline.
  
        Semi-Structured Interviews with health care providers who help people who want to quit
        smoking:
  
        There is little guidance regarding health care providers' (HCP) perspectives in recommending
        digital health solutions to their patients. Understanding the perspectives of HCPs is crucial
        to facilitate the effective delivery and uptake of the healthbot. These interviews will
        explore: (1) barriers/facilitators influencing HCPs provision of digital health solutions to
        patients prescribed varenicline; (2) Identify theoretical domains to target for behaviour
        change; (3) Select BCTs to include in the healthbot.
  
        Wizard of Oz Method:
  
        The purpose of this stage is to test a minimum viable product to determine whether the
        product needs a pivot. Pivots are structured improvements designed to test new fundamental
        hypotheses about products, strategies, and growth engines and often occur in the early stages
        of product development. The Wizard of Oz (WoZ) method is a popular approach wherein research
        participants interact with a computer system they believe is autonomous; however, responses
        are actually generated by an unseen human being (the wizard). It is useful in iterative
        development as it is very easy to change and evolve the wizard's responses.
  
        Building the healthbot (Build Phase):
  
        Following guidance from the Nonadoption, abandonment, scale-up, spread, and sustainability
        (NASSS) framework, the investigators will build the healthbot choosing the simplest sensible
        solution for the design. For this study, the investigators will build a rule-based healthbot,
        that has capabilities to determine the meaning of users' words. The rules will come from the
        literature review, the interviews, and WoZ testing. Specifically, following the discovery
        phase, the research team will rate all BCTs identified as possible contributors to helping
        people adhere to their varenicline based on whether it is affordable, practical, effective,
        acceptable, safe and equitable (APEASE criteria).
  
        Training and testing (Test Phase):
  
        The interviews and WoZ data will serve to help train the healthbot. In addition, once the
        investigators have a working prototype of the healthbot, team members including clinicians
        and researchers will interact with the healthbot to beta test and validate it.
  
        B: Evaluate the implementation outcomes; examine medication adherence and smoking cessation
        success among participants who use the healthbot:
  
        The investigators will conduct a non-randomized single arm feasibility study. It will only
        have an intervention group (with no control group) and is designed to examine important study
        procedures (e.g., patient recruitment, retention, missing data), in advance of a larger
        randomized controlled trial (RCT) testing the effectiveness of the healthbot.
  
        Interested individuals will contact research staff, who will explain the study and assess for
        inclusion criteria. If eligible, participants will be sent a consent form and scheduled for a
        phone-based consent discussion. Once consent is received, an in person or virtual baseline
        visit will be scheduled where participants (n=40) will complete an online questionnaire,
        including questions related to socio-demographic characteristics, smoking dependency, and an
        adapted scale to measure varenicline adherence self-efficacy. They will have a virtual on in
        person visit a healthcare provider for eligibility confirmation and obtain a prescription for
        varenicline the first four weeks (one tablet [0.5 mg] daily for the first three days, one
        tablet [0.5 mg] twice daily for the next four days, and one tablet [1 mg] twice daily for
        three weeks). In addition, research staff will show participants how to use the healthbot on
        their phones. A follow up visit will be scheduled at two weeks where healthcare providers
        will assess the participant's tolerance of varenicline and provide a prescription for the
        remaining eight weeks (one tablet (1 mg) twice daily or a different dose depending on the
        tolerance of each participant). Medication will be provided in person or mailed to the
        participants based on the format of their baseline and follow up healthcare provider visit.
        Any unanticipated problems due to varenicline use (i.e., adverse events that are unexpected
        in terms of severity, nature or frequency; related, or possibly related to participation in
        the research; and suggest that the research places other research participants at greater
        risk of harm) will be documented as applicable and reported to the Research Ethics Board and
        adverse drug reactions will be reported to the Market Authorization Holder (APOTEX) as
        applicable.
  
        The healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information
        and suggestions on managing known side effects (the most frequently cited reason for
        varenicline non-adherence is experiencing side effects); 3) answers to questions about
        medication use (e.g., what to do if a dose is missed); 4) tracking medication intake and
        smoking; 5) support and encouragement to increase participants' motivation to continue their
        quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to
        take their varenicline at the appropriate times and will be able to interact with the
        healthbot when they want.
  
        At 1, 4, 8, and 12 weeks, participants will complete a survey. At the beginning of the study,
        participants will be able to choose if they answer the questions through the healthbot or
        online. All participants who do not complete the online/healthbot follow-up within the
        timeframe allowed will be contacted by phone from research staff. In addition, after the 12
        weeks of using the healthbot, participants will participate in a 1-hour semi-structured phone
        interview.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The investigators will conduct a non-randomized single arm feasibility study. It will only have an intervention group, and is designed to examine important study procedures (e.g., patient recruitment, retention, missing data), in advance of a larger randomized controlled trial (RCT) testing the effectiveness of the healthbot.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acceptability
  time frame: 12 weeks
  description: The extent to which an innovation is agreeable, palatable, or satisfactory to a stakeholder. In order to measure acceptability, the investigators will utilize the four-item Acceptability of Intervention Measure (AIM) in the follow up surveys and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The acceptability will also be assessed through open ended questions in the semi-structured interviews.
  measure: Appropriateness
  time frame: 12 weeks
  description: The perceived fit or compatibility of an innovation with a practice setting or context. For this study, appropriateness will be measured at the individual level (e.g., alignment with users' attitudes, needs, and background) in the 12 week survey, with the Intervention Appropriateness Measure (IAM), a validated 4-item intervention appropriateness scale, and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The appropriateness will also be assessed in-depth in the semi-structured interviews.
  measure: Fidelity
  time frame: 12 weeks
  description: The extent to which an intervention is used as intended. For this study, the investigators will explore in the semi-structured interviews what functions of the healthbot participants used, what they used the healthbot for (e.g., answer questions, receive support), frequency of use, and quality, i.e., whether the healthbot delivered the correct information according to the user.
  measure: Adoption
  time frame: 12 weeks
  description: The intention, decision, or initiation of use for an evidence-based practice, characterizing it at the level of the provider or organization. Given that the concept of adoption aligns with constructs of actual system use, researchers examining behavioural intervention technologies (such as the healthbot) have expanded this level of analysis to that of the consumer. In this study, the investigators will measure the adoption of the healthbot by examining analytics data, which the healthbot will passively collect in in-app logs, during the 12 weeks that the participant is scheduled to take the varenicline.
  The investigators will measure adoption through multiple healthbot analytics, including when (day/time) the user interacted with the healthbot, which features were used, and time spent engaged. If the mean use is ≤20 time, it will be considered as the cutoff point to not progress to a randomized controlled trial.
  We will also explore participants' perceived use of the hea
  measure: Usability
  time frame: 12 weeks
  description: Will be assessed using the System Usability Scale (SUS). The SUS is a 10-item measure assessing usability and user satisfaction with technology. A score of ≤40 will be considered as the cutoff point to not progress to a randomized controlled trial.
  measure: Medication Adherence
  time frame: 12 weeks
  description: Participants will be asked about their medication adherence using timeline follow-back (TLFB) in the surveys collected at 1, 4, 8, and 12 weeks. Participants will report the number of pills taken since the previous assessment. Participants will be asked to send pictures of the blister packs via email at 1, 4, 8, and 12 weeks. These two methods will be used to assess the feasibility of measuring adherence through these different methods, to help understand which method would be most appropriate for any follow up RCT. Participants who used the healthbot to log their medications will be able to import this data to the survey. We selected TLFB to measure adherence since the 12 week TLFB measure is moderately correlated with saliva varenicline levels, and is considered the best practical measure of varenicline adherence.
  measure: Smoking Status
  time frame: 12 weeks
  description: Smoking abstinence will be assessed during the follow up surveys at 1, 4, 8 and 12 weeks, and will be defined by a negative response to the dichotomous 7-day point prevalence question, "Have you had a cigarette, even a puff, in the last seven days?"
  arm group label: Varenicline healthbot
  arm group type: Experimental
  description: While the exact healthbot features will be based on results from the rapid review, interviews and Wizard of OZ testing, the investigators know from the existing literature on medication adherence, and behaviour change interventions, that the healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information and suggestions on managing known side effects (the most frequently cited reason for varenicline non-adherence is experiencing side effects); 3) answers to questions about medication use (e.g., what to do if a dose is missed); and 4) support to increase participants' motivation to continue their quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to take their varenicline at the appropriate times, and will be able to interact with the healthbot when they want.
  intervention type: Other
  intervention name: Varenicline healthbot
  description: The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.
  arm group label: Varenicline healthbot
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nadia Minian, PhD
  role: Principal Investigator
  affiliation: CAMH
  last name: Nadia Minian, PhD
  phone: 4165358501
  phone ext: 77420
  email: Nadia.Minian2@camh.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
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  citation: Booke J. SUS-A quick and dirty usability scale. In Jordan P, Thomas B, (Eds). Usability Evaluation In Industry: Taylor and Francis 1996.
  citation: Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict. 1989 Jul;84(7):791-9. doi: 10.1111/j.1360-0443.1989.tb03059.x.
  PMID: 2758152
  citation: Brown RA, Burgess ES, Sales SD, et al. Reliability and validity of a smoking timeline follow-back interview. Psychology of Addictive Behaviors. 1998;12(2):101-112.
  citation: Peng AR, Morales M, Wileyto EP, Hawk LW Jr, Cinciripini P, George TP, Benowitz NL, Nollen NL, Lerman C, Tyndale RF, Schnoll R. Measures and predictors of varenicline adherence in the treatment of nicotine dependence. Addict Behav. 2017 Dec;75:122-129. doi: 10.1016/j.addbeh.2017.07.006. Epub 2017 Jul 12.
  PMID: 28728040
  responsible party type: Principal Investigator
  investigator affiliation: Centre for Addiction and Mental Health
  investigator full name: Nadia Minian
  investigator title: Scientist
  mesh term: Varenicline