Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Appropriateness
研究概览
简要总结
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:
- What are the challenges to varenicline adherence and strategies to overcome such challenges from the perspective of service users and service providers?
- What features of a healthbot would help improve adherence to varenicline?
- 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.
详细描述
A: Co-design a theory informed healthbot to support patients' adherence to varenicline:
The investigators will employ a user-centred approach to build the healthbot in order to optimize user experience and achieve the best uptake and utilization. Following the Discover, Design and Build, and Test (DDBT) framework, the investigators will use a three-step approach to co-design the core functionality of the healthbot: 1) review the literature and conduct interviews with potential users (Discovery Phase); 2) design the healthbot and conduct Wizard of Oz testing (Design/Build Phase); 3) Train and test the healthbot (Test Phase).
Literature review:
The aim of this rapid review is two folded: 1) to identify the barriers and facilitators to varenicline adherence, in people using varenicline for smoking cessation (the investigators will use the Theoretical Domains Framework (TDF) to organize the data extraction), and 2) to identify the behaviour change techniques (BCTs) that are associated with helping people adhere to their varenicline treatment (the investigators will use BCTT v1. to organize the data extraction). The study was registered with PROSPERO (# CRD42022321838).
Semi-Structured Interviews with people who use varenicline:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Have contraindication(s) to varenicline use;
- •Are pregnant/planning to become pregnant/breastfeeding;
- •Participated in the co-design phase.
结局指标
主要结局
Appropriateness
时间窗: 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, and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The appropriateness will also be assessed in-depth in the semi-structured interviews.
Fidelity
时间窗: 12 weeks
The extent to which an intervention is used as intended. For this study, the investigators will explore in the semi-structured interviews what functions of the healthbot participants used, what they used the healthbot for (e.g., answer questions, receive support), frequency of use, and quality, i.e., whether the healthbot delivered the correct information according to the user.
Acceptability
时间窗: 12 weeks
The extent to which an innovation is agreeable, palatable, or satisfactory to a stakeholder. In order to measure acceptability, the investigators will utilize the four-item Acceptability of Intervention Measure (AIM) in the follow up surveys and a score of ≤8 will be considered as the cutoff point to not progress to a randomized controlled trial. The acceptability will also be assessed through open ended questions in the semi-structured interviews.
Adoption
时间窗: 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. We will also explore participants' perceived use of the hea
Usability
时间窗: 12 weeks
Will be assessed using the System Usability Scale (SUS). The SUS is a 10-item measure assessing usability and user satisfaction with technology. A score of ≤40 will be considered as the cutoff point to not progress to a randomized controlled trial.
次要结局
- Medication Adherence(12 weeks)
- Smoking Status(12 weeks)
研究者
Nadia Minian
Scientist
Centre for Addiction and Mental Health