Trial Outcomes & Findings for Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study (NCT NCT05997901)

Last Updated: 2026-03-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-03-31

Participant Flow

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)

Participant milestones

Participant milestones
Measure	Varenicline Healthbot 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. Varenicline healthbot: The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline Healthbot 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. Varenicline healthbot: The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline Healthbot n=40 Participants 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.
Sex/Gender, Customized Women	19 Participants n=4 Participants
Sex/Gender, Customized men	21 Participants n=4 Participants
Age, Customized 18-40	13 Participants n=4 Participants
Age, Customized 41-60	16 Participants n=4 Participants
Age, Customized 61+	11 Participants n=4 Participants
Race/Ethnicity, Customized White	34 Participants n=4 Participants
Race/Ethnicity, Customized Métis, Black, Latino/Latina/Latinx, Middle Eastern	6 Participants n=4 Participants
Fagerström Test of Cigarette Dependence score	4.56 score on a scale STANDARD_DEVIATION 2.14 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 34 participants had complete data across all timepoints.

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Acceptability of Intervention Measure (AIM)	15.76 Mean acceptability score at 12 weeks Standard Deviation 3.89

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Appropriateness	16.56 Mean appropriateness score at 12 weeks Standard Deviation 3.41

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Adoption	81.2 usage in mins Full Range 20.64 • Interval 1.2 to 1161.3

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Usability	74.63 Total usability score Standard Deviation 20.64 • Interval 25.0 to 100.0

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Medication Adherence	25 Participants

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Varenicline Healthbot n=34 Participants 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.
Smoking Status	11 Participants

Adverse Events

Varenicline Healthbot

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Varenicline Healthbot n=40 participants at risk 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.
Nervous system disorders Stroke	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.

Other adverse events

Other adverse events
Measure	Varenicline Healthbot n=40 participants at risk 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.
Psychiatric disorders Insomnia	7.5% 3/40 • Number of events 3 • 12 weeks Adverse events were monitored throughout the study.
Nervous system disorders Hypersomnia	5.0% 2/40 • Number of events 2 • 12 weeks Adverse events were monitored throughout the study.
General disorders Lethargy	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
General disorders Tired	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Abnormal dreams	30.0% 12/40 • Number of events 13 • 12 weeks Adverse events were monitored throughout the study.
General disorders Fatigue	12.5% 5/40 • Number of events 5 • 12 weeks Adverse events were monitored throughout the study.
Infections and infestations Herpes zoster	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Nervous system disorders Somnolence	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Sleep disorder	12.5% 5/40 • Number of events 5 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Nausea	40.0% 16/40 • Number of events 17 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders vomiting	40.0% 16/40 • Number of events 17 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Depressed mood	10.0% 4/40 • Number of events 4 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Anger	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Emotional disorder	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Irritability	5.0% 2/40 • Number of events 2 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Apathy	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Psychiatric disorders Agitation	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Nervous system disorders Headache	7.5% 3/40 • Number of events 3 • 12 weeks Adverse events were monitored throughout the study.
Nervous system disorders Dizziness	7.5% 3/40 • Number of events 3 • 12 weeks Adverse events were monitored throughout the study.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Chills	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
General disorders Hyperhidrosis	2.5% 1/40 • Number of events 2 • 12 weeks Adverse events were monitored throughout the study.
General disorders Feeling cold	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
General disorders Hot flush	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Heartburn	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Respiratory, thoracic and mediastinal disorders Productive cough	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Number of events 2 • 12 weeks Adverse events were monitored throughout the study.
Vascular disorders Blood pressure increased	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Cardiac disorders Palpitations	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Dry mouth	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Constipation	5.0% 2/40 • Number of events 2 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Gastroesophageal reflux disease	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Metabolism and nutrition disorders Decreased appetite	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Diarrhoea	10.0% 4/40 • Number of events 4 • 12 weeks Adverse events were monitored throughout the study.
Nervous system disorders Dysgeusia	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Gastrointestinal disorders Dyspepsia	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.
Skin and subcutaneous tissue disorders Rash	2.5% 1/40 • Number of events 1 • 12 weeks Adverse events were monitored throughout the study.

Additional Information

The feasibility of an artificial intelligence conversational agent to improve varenicline adherence

CAMH

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place