AI Chatbot for Migraine Management in Hong Kong Women

NCT06920602 | Completed

• 2 other identifiers: HSEARS20241015007RG2024/2025_A_11
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; RCT; migraine diary; artificial intelligence; chatbot

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

AI-empowered voice-interactive chatbot followed by paper migraine diary

Device: AI-empowered voice-interactive chatbot; Device: Paper migraine diary

Sequence 2

EXPERIMENTAL

Paper migraine diary followed by AI-empowered voice-interactive chatbot

Device: Paper migraine diary; Device: AI-empowered voice-interactive chatbot

Interventions

Paper migraine diary DEVICE

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.

Sequence 1

AI-empowered voice-interactive chatbot DEVICE

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.

Sequence 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Nethersole Institute of Continuing Holistic Health Education (NICHE): collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, HONG KONG, Hong Kong

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yao Jie Xie, PhD

  The Hong Kong Polytechnic Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 10, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)