AI Chatbot for Migraine Management in Hong Kong Women

Not Applicable

Not yet recruiting

• Conditions: Migraine

• Registration Number: NCT06920602
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-10
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Study Start: 2025-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Compliance	At the end of each 1-month intervention period	Compliance will be assessed using backdated records, complete records, and missed records. Backdated records will be calculated as the proportion of records completed on the day or the following day of the migraine attack, providing an indication of participants' adherence to timely migraine tracking. Complete records will be determined as the proportion of the migraine dairy records containing all required information, reflecting the completeness of participants' migraine data entry. Missed records will be calculated as the proportion of self-reported miss-recorded migraine attack entries compared to the total number of migraine attacks, offering insights into the potential underreporting of migraine attacks. These compliance measures will be derived from the data collected through the chatbot and paper diary, allowing for a comparison of compliance between the two migraine tracking methods.
Accuracy	At the end of each 1-month intervention period	The accuracy of the recorded migraine data will be evaluated by assessing the consistency between migraine features recorded using the chatbot or paper diary and those reported during end-of-period interviews with study staff. During these interviews, participants will be asked to provide a detailed account of their migraine experiences and the perceived accuracy of migraine features.

Secondary Outcome Measures

Name	Time	Method
Utilization	At the end of each 1-month intervention period	Utilization will be evaluated using the Chinese version of the System Usability Scale (SUS), a widely used and validated 10-item questionnaire that assesses the usability of a system on a 5-point Likert scale. The SUS yields a single score ranging from 0 to 100, with higher scores indicating better usability. Specifically, chatbot utilization will be objectively assessed using system-generated data, such as the number of logins, user-initiated conversations, and user responses.
Acceptability	At the end of each 1-month intervention period	Acceptability will be measured using the Chinese scale of the Inventory of Technology Acceptance Model. The scale is a 11-item questionnaire that assesses the acceptability of an intervention on a 7-point Likert scale. The average score ranges from 11 to 77 and higher scores indicate greater acceptability.
Feasibility	At the end of each 1-month intervention period	Feasibility will be assessed using the recruitment rate, retention rate, usage frequency and time cost when tracking migraine features.
Validity	At the end of each 1-month intervention period	The validity of the migraine data collected through the chatbot and paper diary will be assessed using convergent validity and divergent validity. Convergent validity will be evaluated by examining the correlation between migraine frequency and severity recorded using the chatbot or paper diary and the Chinese version of the Migraine Disability Assessment (MIDAS) scores (0 to 270, higher scores indicating greater migraine-related disability). Divergent validity will be assessed by analyzing the correlation between migraine frequency and severity and the Chinese version of the Brief Self-Control Scale (7 to 35, with a higher score indicating greater self-control).

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong