CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Varenicline healthbotother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05997901
NCT05997901N/ACompleted

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

Centre for Addiction and Mental Health·interventional·Posted Aug 18, 2023·Updated Mar 31, 2026

In Brief

A clinical study evaluating Varenicline healthbot for Medication Adherence and Smoking Cessation. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
202420252026
First PostedAug 18, 2023
Enrollment StartJun 1, 2024
Primary CompletionApr 23, 2025
Study CompletionMay 5, 2025
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.9 years ago

Interventions

Varenicline healthbotother

The intervention is a healthbot that will provide information, reminders, answers to questions, and support to participants using varenicline for smoking cessation.