Development and Evaluation of an AI-empowered Voice-interactive Chatbot for Migraine Management Among Hong Kong Women: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
The goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based migraine diaries among Hong Kong women with migraine.
Participants will use different tools (AI-empowered voice-interactive chatbot or paper migraine diary) for migraine tracking. Participants will be randomly allocated to one of two intervention sequences: (1) AI-empowered voice-interactive chatbot followed by paper migraine diary, or (2) paper migraine diary followed by AI-empowered voice-interactive chatbot. The study will consist of two intervention periods, each lasting one month, with a 1:1 allocation ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older
- •Meet diagnostic criteria for migraine according to ICHD-3
- •Experiencing at least 2 headache days per month
- •Living in Hong Kong
- •Fluent in Cantonese
- •Owning a smartphone with internet access
- •Willing to provide informed consent
排除标准
- •Individuals with severe cognitive impairments or communication difficulties
- •Those unable to use a smartphone or the chatbot due to physical or mental limitations
- •Using another alternative electronic migraine diary during recruitment or in the past 12 weeks
研究组 & 干预措施
Sequence 1
AI-empowered voice-interactive chatbot followed by paper migraine diary
干预措施: AI-empowered voice-interactive chatbot (Device)
Sequence 1
AI-empowered voice-interactive chatbot followed by paper migraine diary
干预措施: Paper migraine diary (Device)
Sequence 2
Paper migraine diary followed by AI-empowered voice-interactive chatbot
干预措施: Paper migraine diary (Device)
Sequence 2
Paper migraine diary followed by AI-empowered voice-interactive chatbot
干预措施: AI-empowered voice-interactive chatbot (Device)
结局指标
主要结局
Accuracy
时间窗: At the end of each 1-month intervention period
Accuracy will be defined as the proportion of diary entries in which all required migraine-related fields were recorded correctly. Accuracy will be adjudicated by assessing the consistency between migraine features recorded using the chatbot or paper diary and those reported during end-of-period online interviews with study staff. Discrepancies will be documented; records will be not altered for primary analyses. During these interviews, researchers will summarise the participant's recorded migraine information for that period, regardless of modality, and ask the participant to identify any errors.
timeliness
时间窗: At the end of each 1-month intervention period
Timeliness will be defined as the proportion of migraine episodes recorded within 24 hours of onset. This measure will be derived from the data collected through the chatbot and paper diary.
Completeness
时间窗: At the end of each 1-month intervention period
Completeness will be defined as the proportion of diary entries with all required migraine-related information fully recorded. This measure will be derived from the data collected through the chatbot and paper diary.
Missed episodes
时间窗: At the end of each 1-month intervention period
Missed episodes will be defined as the proportion of migraine episodes not recorded; the number of missed episodes in each period will be obtained at the end-of-period questionnaire
Accuracy
时间窗: At the end of each 1-month intervention period
Accuracy will be defined as the proportion of diary entries in which all required migraine-related fields were recorded correctly. Accuracy will be adjudicated by assessing the consistency between migraine features recorded using the chatbot or paper diary and those reported during end-of-period online interviews with study staff. Discrepancies will be documented; records will be not altered for primary analyses. During these interviews, researchers will summarise the participant's recorded migraine information for that period, regardless of modality, and ask the participant to identify any errors.
次要结局
- Utilization(At the end of each 1-month intervention period)
- Acceptability(At the end of each 1-month intervention period)
- Validity(At the end of each 1-month intervention period)
- Utilization(At the end of each 1-month intervention period)
- Acceptability(At the end of each 1-month intervention period)
- Usage(At the end of each 1-month intervention period)
- Time per recording(At the end of each 1-month intervention period)
- Validity(At the end of each 1-month intervention period)
研究者
XIE Yao Jie Grace
Associate Professor
The Hong Kong Polytechnic University