An interventional study of Varenicline healthbot in Medication Adherence and Smoking Cessation, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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:
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 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 be asked a few baseline questions related to socio-demographic characteristics, smoking dependency, and an adapted scale to measure varenicline adherence self-efficacy. They will have a virtual or in person visit with a healthcare provider for eligibility confirmation and obtain a prescription for varenicline for 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. All participants who do not complete the follow-up survey 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.
223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.
This study's enrollment of 40 is below the median of 118 across 189 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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.
Other: Varenicline healthbot
The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.
Acceptability of Intervention Measure (AIM)
The extent to which an innovation is agreeable, palatable, or satisfactory to a stakeholder. In order to measure acceptability, we used the four-item Acceptability of Intervention Measure (AIM) in the follow up surveys. The Acceptability of Intervention Measure (AIM) is a 4-item scale assessing perceived acceptability. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). The total AIM score is the sum of the four items, yielding a range of 4-20, with higher scores indicating greater acceptability. Unit of Measure: score on a scale (4-20).
Time frame: 12 weeks
Appropriateness
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. The IAM includes 4 items, each rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Item responses are summed to generate a total IAM score ranging from 4 to 20, with higher scores indicating greater perceived appropriateness of the intervention.
Time frame: 12 weeks
Adoption
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.
Time frame: 12 weeks
Usability
Will be assessed using the System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with alternating positively and negatively worded items. Responses are summed and converted to a total score ranging from 0 to 100, with higher scores indicating better perceived usability. A SUS score of 68 is considered average usability, with scores above 68 indicating above-average usability and scores below 68 suggesting usability concerns. Scores above approximately 80 are typically interpreted as excellent usability, while scores below 50 indicate poor usability. SUS scores
Time frame: 12 weeks
Medication Adherence
The Timeline Follow-Back (TLFB) method was used to assess adherence to varenicline. TLFB is a validated, calendar-based retrospective reporting method in which participants indicate the number of varenicline pills taken since their previous study visit. TLFB surveys were collected at Weeks 1, 4, 8, and 12. For each interval, adherence was calculated as: (Number of pills reportedly taken ÷ Number of pills prescribed for that interval) Participants were classified as adherent if they took ≥80% of their prescribed varenicline doses during each interval. The reported outcome reflects the number of participants who, at the 12-week assessment, were ≥80% adherent at Weeks 1, 4, 8, and 12.
Time frame: 12 weeks
Smoking Status
Smoking abstinence was assessed during the follow-up survey at 12 weeks. Abstinence was defined using the dichotomous 7-day point-prevalence question: "Have you had a cigarette, even a puff, in the last seven days?" Participants who responded "No" were classified as abstinent. The outcome reflects the number of participants who had quit smoking at the 12-week assessment.
Time frame: 12 weeks
Between May-December 2024, 83 individuals were pre-screened, 40 were eligible and enrolled. Please note that other parts of the study (co- design started in June 2024)
| Milestone | Varenicline Healthbot |
|---|---|
| Started | 40 |
| Completed | 36 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
The extent to which an innovation is agreeable, palatable, or satisfactory to a stakeholder. In order to measure acceptability, we used the four-item Acceptability of Intervention Measure (AIM) in the follow up surveys. The Acceptability of Intervention Measure (AIM) is a 4-item scale assessing perceived acceptability. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). The total AIM score is the sum of the four items, yielding a range of 4-20, with higher scores indicating greater acceptability. Unit of Measure: score on a scale (4-20).
| Mean acceptability score at 12 weeks | Varenicline Healthbot |
|---|---|
| Acceptability of Intervention Measure (AIM) | 15.76 ± 3.89 |
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. The IAM includes 4 items, each rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Item responses are summed to generate a total IAM score ranging from 4 to 20, with higher scores indicating greater perceived appropriateness of the intervention.
| Mean appropriateness score at 12 weeks | Varenicline Healthbot |
|---|---|
| Appropriateness | 16.56 ± 3.41 |
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.
| usage in mins | Varenicline Healthbot |
|---|---|
| Adoption | 81.2 ± 20.64 |
Will be assessed using the System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with alternating positively and negatively worded items. Responses are summed and converted to a total score ranging from 0 to 100, with higher scores indicating better perceived usability. A SUS score of 68 is considered average usability, with scores above 68 indicating above-average usability and scores below 68 suggesting usability concerns. Scores above approximately 80 are typically interpreted as excellent usability, while scores below 50 indicate poor usability. SUS scores
| Total usability score | Varenicline Healthbot |
|---|---|
| Usability | 74.63 ± 20.64 |
The Timeline Follow-Back (TLFB) method was used to assess adherence to varenicline. TLFB is a validated, calendar-based retrospective reporting method in which participants indicate the number of varenicline pills taken since their previous study visit. TLFB surveys were collected at Weeks 1, 4, 8, and 12. For each interval, adherence was calculated as: (Number of pills reportedly taken ÷ Number of pills prescribed for that interval) Participants were classified as adherent if they took ≥80% of their prescribed varenicline doses during each interval. The reported outcome reflects the number of participants who, at the 12-week assessment, were ≥80% adherent at Weeks 1, 4, 8, and 12.
| Participants | Varenicline Healthbot |
|---|---|
| Medication Adherence | 25 |
Smoking abstinence was assessed during the follow-up survey at 12 weeks. Abstinence was defined using the dichotomous 7-day point-prevalence question: "Have you had a cigarette, even a puff, in the last seven days?" Participants who responded "No" were classified as abstinent. The outcome reflects the number of participants who had quit smoking at the 12-week assessment.
| Participants | Varenicline Healthbot |
|---|---|
| Smoking Status | 11 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline Healthbot | 0/40 (0%) | 1/40 (2.5%) | 34/40 (85%) |
| Event | Varenicline Healthbot |
|---|---|
| StrokeNervous system disorders | 1/40 |
| Event | Varenicline Healthbot |
|---|---|
| NauseaGastrointestinal disorders | 16/40 |
| vomitingGastrointestinal disorders | 16/40 |
| Abnormal dreamsPsychiatric disorders | 12/40 |
| FatigueGeneral disorders | 5/40 |
| Sleep disorderPsychiatric disorders | 5/40 |
| Depressed moodPsychiatric disorders | 4/40 |
| DiarrhoeaGastrointestinal disorders | 4/40 |
| InsomniaPsychiatric disorders | 3/40 |
| HeadacheNervous system disorders | 3/40 |
| DizzinessNervous system disorders | 3/40 |
| Sex/Gender, Customized(Participants) | Varenicline Healthbot |
|---|---|
| Women | 19 |
| men | 21 |
| Age, Customized(Participants) | Varenicline Healthbot |
|---|---|
| 18-40 | 13 |
| 41-60 | 16 |
| 61+ | 11 |
| Race/Ethnicity, Customized(Participants) | Varenicline Healthbot |
|---|---|
| White | 34 |
| Métis, Black, Latino/Latina/Latinx, Middle Eastern | 6 |
| Fagerström Test of Cigarette Dependence score(score on a scale) | Varenicline Healthbot |
|---|---|
| Mean | 4.56 ± 2.14 |
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