Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2023
Date Accepted: Nov 23, 2023
The feasibility of an artificial intelligence conversational agent to improve varenicline adherence: A study protocol
ABSTRACT
Background:
Interventions to increase medication adherence may help improve treatment and healthcare system efficiencies and cost-effectiveness. Digital health solutions are such intervention that can help improve medication adherence by providing reminders, answering questions and tracking medication intake. “ChatV” is an evidence-based, patient- and health care provider-informed healthbot to improve adherence to varenicline, a smoking cessation medication.
Objective:
To conduct a feasibility study to examine if the ChatV healthbot is used as intended, as well as to determine the appropriateness of proceeding with a randomized controlled trial.
Methods:
We will conduct a mixed-methods feasibility study where 40 participants will be prescribed varenicline and interact with the healthbot programmed to provide medication reminders, answering questions about varenicline and smoking cessation, and tracking medication intake and number of cigarettes. Follow-up survey data will be collected at 1, 4, 8, and 12 weeks and a semi-structured interview will be conducted at 12 weeks to understand participants’ experiences using the healthbot. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and utilization of this digital health solution among diverse socio-demographic groups. The Taxonomy of Implementation Outcomes will be used to assess the feasibility, i.e., acceptability, appropriateness, fidelity, adoption and usability. In addition, medication adherence and smoking cessation will be measured to assess preliminary treatment effect. Interview data will be analysed using framework analysis method.
Results:
The study has been approved by the Centre for Addiction and Mental Health’s Research Ethics Board (#50/2022). Participant enrollment for the study will begin in November 2023.
Conclusions:
By employing predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance towards a larger randomised controlled trial to test the effectiveness of the healthbot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the healthbot. These insights will be instrumental in refining the intervention/healthbot. Clinical Trial: Registry name: Clinicaltrials.gov Registration URL: https://classic.clinicaltrials.gov/ct2/show/NCT05997901 Registration number: NCT05997901
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