AI Chatbot for Migraine Management in Hong Kong Women

Development and Evaluation of an AI-empowered Voice-interactive Chatbot for Migraine Management Among Hong Kong Women: a Randomized Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: AI-empowered voice-interactive chatbot; Device: Paper migraine diary

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • HONG KONG
    • Hong Kong, HONG KONG, Hong Kong
      • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; AI-empowered voice-interactive chatbot followed by paper migraine diary	Device: AI-empowered voice-interactive chatbot; Participants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system.; Device: Paper migraine diary; Participants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use.
Experimental: Sequence 2; Paper migraine diary followed by AI-empowered voice-interactive chatbot	Device: AI-empowered voice-interactive chatbot; Participants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system.; Device: Paper migraine diary; Participants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
timeliness	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.	At the end of each 1-month intervention period
Completeness	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.	At the end of each 1-month intervention period
Missed episodes	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	At the end of each 1-month intervention period
Accuracy	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.	At the end of each 1-month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization	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.	At the end of each 1-month intervention period
Validity	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).	At the end of each 1-month intervention period
Acceptability	Acceptability will be measured using the validated Chinese version of Technology Acceptance Model (TAM) scale, an 11-item questionnaire on a 7-point Likert scale with higher scores indicating greater acceptance.	At the end of each 1-month intervention period
Usage	Usage will be assessed by the number of uses (entries) per tool.	At the end of each 1-month intervention period
Time per recording	Time required to record each migraine episode, using system-logged durations for the chatbot and self-recorded start and finish times for the paper diary.	At the end of each 1-month intervention period

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Nethersole Institute of Continuing Holistic Health Education (NICHE)
• Investigators: Principal Investigator: Yao Jie Xie, PhD, The Hong Kong Polytechnic Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: RCT; artificial intelligence; migraine; chatbot; migraine diary
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: HSEARS20241015007; RG2024/2025_A_11 (Other Grant/Funding Number: NICHE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No