Skip to main content
OpenTrials
Completed

NCT Number: NCT06920602

AI Chatbot for Migraine Management in Hong Kong Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, HONG KONG

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. timeliness

    Time frame: 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.

  2. Completeness

    Time frame: 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.

  3. Missed episodes

    Time frame: 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

  4. Accuracy

    Time frame: 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.

Secondary outcomes

  1. Utilization

    Time frame: 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.

  2. Acceptability

    Time frame: At the end of each 1-month intervention period

    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.

  3. Usage

    Time frame: At the end of each 1-month intervention period

    Usage will be assessed by the number of uses (entries) per tool.

  4. Time per recording

    Time frame: At the end of each 1-month intervention period

    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.

  5. Validity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Nethersole Institute of Continuing Holistic Health Education (NICHE)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.