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

NCT05997901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-31

Study results available
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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.

Conditions

  • Medication Adherence
  • Smoking Cessation

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Nadia Minian, PhD · CAMH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-04-23
Completion
2025-05-05

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997901 on ClinicalTrials.gov