Perfect Fit: A Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach
研究概览
简要总结
The leading cause of disease burden across the globe is cardiovascular disease (CVD). Important modifiable behavioral CVD risk factors include, amongst others, smoking and low physical activity (PA). Individuals with a low socioeconomic position (SEP) often have a less favorable profile of risk factors, resulting in a higher disease burden and premature death. There is a need for cost-effective multi-behavior interventions that target one or more risk factors. eHealth applications are increasingly being used to offer behavior change interventions. Potential benefits include accessibility, scalability, cost-effectiveness, and increased disease self-management. However, eHealth interventions are often static and thereby less effective, and also frequently developed without (sufficiently) engaging end-users. Involving end-users, including those from lower SEP groups, and other relevant stakeholders can help to optimize the adoption and adherence to the eHealth intervention and result in the maintenance of healthy behavior.
The Perfect Fit intervention is the result of interdisciplinary collaboration, and the personalized eHealth intervention supports adult smokers to stop smoking and increase their PA using a virtual coach. We primarily aim to examine the feasibility, acceptability and preliminary effectiveness of the Perfect Fit intervention.
A mixed-method single-arm pre-post intervention study will be used. The intervention, delivered through a virtual coach, has a personalized duration and intensity, but will last on average 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
N/A due to single-arm study.
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
- •18 years or older
- •Current smoker (cigarette, cigar, or rolling tobacco)
- •Intention to quit smoking between now and 6 weeks
- •Being able to walk without pain complaints
- •Being able to understand and read Dutch (B1 level)
- •Having access to the internet and a smartphone
- •In addition, at least 50% of sample has ≥10% risk of CVD (Nederlands Huisartsen Genootschap, 2019), estimated on basis of:
- •- Being female and 55+ years old OR male and 50+ years old
- •Finally, at least 75% of sample is:
- •- Living in region Leiden (region between Leiden/Amsterdam/Utrecht)
排除标准
- •Being involved in smoking cessation therapy/counseling at the start of the intervention.
- •Has undergone major lower extremity surgery in the past year (to prevent giving PA advice that contradicts medical guidance).
- •Taking antipsychotics or having a serious psychiatric illness (e.g., schizophrenia/psychosis, bipolar disorder, major depression).
- •Being pregnant.
- •Not able to wear the smartwatch throughout the day (e.g., when individuals are not allowed to wear a watch at work)
结局指标
主要结局
Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach
时间窗: Assessed after the intervention, at week 16 (post-intervention, T1)
Assess feasibility of the Perfect Fit intervention using: 1. usage data on which components of the intervention (i.e., chat conversations, exercises, informational videos) are completed at certain timepoints (measured from baseline to post-intervention, T1). Users who complete all the preparation phase dialogs, complete at least one dialog per week during the execution phase of the intervention, and complete the closing dialogue, will be marked as adherent users. 2. a self-report question about the frequency of contact with the virtual coach; Users will be asked to indicate how many times a week they had contact with their virtual coach during the Perfect Fit intervention.
Acceptability of the Perfect Fit intervention assessed by the CSQ-8
时间窗: Assessed after the intervention, at week 16 (post-intervention, T1)
Participants' satisfaction with the Perfect Fit intervention and the chat function of the NiceDay app (the app that is used for chat interaction between the user and the virtual coach) will be measured with the Dutch translation of the 8-item Client Satisfaction Questionnaire (CSQ-8; De Wilde \& Hendriks, 2005; Larsen, 1979). An example of an item is: "To what extent has our service \[the Perfect Fit program\] met your needs?". The items are scored on 4-point Likert scales with different labels (e.g., from 1 (quite dissatisfied) to 4 (very satisfied)) and the total score ranges from 8 to 32, with a higher score indicating greater satisfaction.
Usability of the Perfect Fit intervention assessed by the SUS
时间窗: Assessed after the intervention, at week 16 (post-intervention, T1)
The usability of the Perfect Fit intervention and the chat function of the NiceDay app will be measured with a Dutch translation of the System Usability Scale (SUS; Brooke, 1996). The total questionnaire consists of ten items with items such as "I think the virtual coach is unnecessary complex" and "I found the various functions in this system were well integrated". The items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Attitudes to the virtual coach assessed by satisfaction and relationship with, usability of and adherence to the virtual coach
时间窗: Assessed after the intervention, at week 16 (post-intervention, T1)
Acceptance of the virtual coach will be assessed using a Dutch translation of a set of six items that measure the evaluation of the coach in terms of satisfaction, usability, continuation of collaboration, relationship, preference for a program with or without coach and adherence to advice from the coach. The questionnaire has been used in other studies evaluating virtual agents (Bickmore et al., 2010; Provoost et al., 2020). Two example items are: "How satisfied were you with the virtual coach?" and "How easy was it talking to the virtual coach?". Answers are given on a 7-point Likert scale with different labels (e.g., from 1 (not at all satisfied) to 7 (very satisfied)).
Qualitative data on primary outcome measures
时间窗: Assessed after the intervention, at week 16 (post-intervention, T1)
Qualitative individual semi-structured interviews with participants will complement the quantitative data and provide more in-depth insight into acceptability, feasibility, preliminary effectiveness, and requirements for implementation of the Perfect Fit intervention.
次要结局
- Preliminary effectiveness of the Perfect Fit intervention: Self-reported smoking abstinence(Assessed four times during the study: at post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Preliminary effectiveness of the Perfect Fit intervention: Self-reported level of PA(Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Preliminary effectiveness of the Perfect Fit intervention: PA self-identity(Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Preliminary effectiveness of the Perfect Fit intervention: Smoking abstinence self-efficacy(Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Preliminary effectiveness of the Perfect Fit intervention: PA self-efficacy(Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Preliminary effectiveness of the Perfect Fit intervention: Objective level of PA(Assessed during the intervention: from baseline (week 0, T0) to post-intervention (week 16, T1))
- Feasibility of the study: Recruitment, response and consent rate(Assessed from the start of the recruitment till inclusion of final participant)
- Preliminary effectiveness of the Perfect Fit intervention: non-smoker self-identity(Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).)
- Feasibility of the study: Recruitment strategies(Assessed before the intervention, at baseline (week 0, T0))
- Feasibility of the study: Adherence(Assessed from the start of the recruitment to the end (week 64, T4) of the study)
- Feasibility of the study: Intervention completion after 16 weeks(Assessed after the intervention, at week 16 (post-intervention, T1))
- Qualitative data on secondary outcome measures(Assessed after the intervention, at week 16 (post-intervention, T1))
研究者
aversluis
Dr. (Assistant professor)
Leiden University Medical Center