N/A
Completed N=40
Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study
Medication Adherence · Smoking Cessation
Source: ClinicalTrials.gov NCT05997901 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Mar 2026
Primary outcomePrimary: Acceptability of Intervention Measure (AIM) — 15.76 Mean acceptability score at 12 weeks
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Intervention Measure (AIM) |
15.76 | — |
| PRIMARY Appropriateness |
16.56 | — |
| PRIMARY Adoption |
81.2 | — |
| PRIMARY Usability |
74.63 | — |
| SECONDARY Medication Adherence |
25 | — |
| SECONDARY Smoking Status |
11 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-seeking smokers who are willing to start taking varenicline and continue it for 12 weeks, and set a quit date in the next 30 days;
- Smoke cigarettes daily (10 or more cigarettes a day)
- Age ≥ 18 years;
- Speak/read English;
- Have a smartphone with data plan;
- Report being committed to answering questions during follow-up;
- Live in Ontario.
Exclusion Criteria
- Have contraindication(s) to varenicline use;
- Are pregnant/planning to become pregnant/breastfeeding;
- Participated in the co-design phase.
Data sourced from ClinicalTrials.gov (NCT05997901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.